Een studie waarin de werkzaamheid, veiligheid en verdraagbaarheid van de vaste dosis drievoudige combinatie CHF 5993 met de vaste dosis dubbele combinatie CHF 1535 bij proefpersonen met COPD werden vergeleken (TRITON)
17 september 2026 bijgewerkt door: Chiesi Farmaceutici S.p.A.
Een fase III, 52 weken durende, multinationale, multicenter, gerandomiseerde, dubbelblinde, 2-armige parallelle groepsstudie waarin de werkzaamheid, veiligheid en verdraagbaarheid van de vaste dosis drievoudige combinatie van beclomethasondipropionaat plus formoterolfumaraat plus glycopyrroniumbromide (CHF 5993) met de vaste dosis dubbele combinatie van beclomethasondipropionaat plus formoterolfumaraat (CHF 1535), beide toegediend via pMDI bij proefpersonen met chronische obstructieve longziekte (COPD)
The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This is a phase III, multinational, multicenter, randomized, double-blind active controlled 2-arm parallel group study to compare efficacy, safety, and tolerability of CHF 5993 pMDI with CHF 1535 pMDI with respect to lung function, incidence of moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes.
After screening, eligible subjects will enter 2-week run-in period using their regular COPD maintenance therapies after which they will be randomized to one of 2 study treatment groups. Following randomization, subjects will be assessed after 4 weeks then at 6-week intervals thereafter for a period of 52 weeks. A follow-up safety phone call will be performed a week after the last clinic visit. A subset of subjects consenting to participate in the pharmacokinetic substudy will undergo additional assessments (totaling 3 visits) during the scheduled study visits.
During the study, daily symptoms, rescue medication use and compliance with the study drug will be recorded via a subject electronic diary. Subject concomitant medications, adverse events, and healthcare resource utilization will be assessed and recorded throughout the study. At intermittent study visits, subjects will undergo vital signs examinations including weight, spirometry measurements, and 12-lead ECG. Symptoms and COPD health status will be assessed through disease specific questionnaires. Routine hematology, blood chemistry, and serum pregnancy testing will be performed before enrollment and at end of study.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
3406
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Buenos Aires, Argentinië, 1407
- Chiesi Clinical Trial Site 032125
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Buenos Aires, Argentinië, C1425FVH
- Chiesi Clinical Trial Site 032130
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Buenos Aires, Argentinië
- Chiesi Clinical Trial Site 032133
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Ciudad Autonoma de Buenos Aire, Argentinië, 1430
- Chiesi Clinical Trial Site 032103
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Ciudad Autonoma de Buenos Aire, Argentinië, B1602DOH
- Chiesi Clinical Trial Site 032109
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Córdoba, Argentinië, 5000
- Chiesi Clinical Trial Site 032122
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Lobos, Argentinië, 7240
- Chiesi Clinical Trial Site 032131
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Mar del Plata, Argentinië, 7600
- Chiesi Clinical Trial Site 032119
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Mendoza, Argentinië, 5500
- Chiesi Clinical Trial Site 032105
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Mendoza, Argentinië, 5500
- Chiesi Clinical Trial Site 032129
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Mendoza, Argentinië, M5502IDE
- Chiesi Clinical Trial Site 032126
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Paraná, Argentinië, 3100
- Chiesi Clinical Trial Site 032123
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Rosario, Argentinië, S2002OJN
- Chiesi Clinical Trial Site 032128
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San Miguel de Tucumán, Argentinië, 4000
- Chiesi Clinical Trial Site 032134
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San Miguel de Tucumán, Argentinië, 4000
- Chiesi Clinical Trial Site 032136
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San Rafael, Argentinië, 5600
- Chiesi Clinical Trial Site 032127
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Santa Fe, Argentinië, 3000
- Chiesi Clinical Trial Site 032124
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Buenos Aires
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentinië, 1056ABJ
- Chiesi Clinical Trial Site 032115
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentinië, 1426
- Chiesi Clinical Trial Site 032113
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentinië, B1837
- Chiesi Clinical Trial Site 032107
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentinië, C1426ABO
- Chiesi Clinical Trial Site 032112
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentinië, Cl425DTG
- Chiesi Clinical Trial Site 032121
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La Plata, Buenos Aires, Argentinië, 1900
- Chiesi Clinical Trial Site 032108
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Mar del Plata, Buenos Aires, Argentinië, 3168
- Chiesi Clinical Trial Site 032118
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Mar del Plata, Buenos Aires, Argentinië, B7600FZO
- Chiesi Clinical Trial Site 032114
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Monte Grande, Buenos Aires, Argentinië, 1842
- Chiesi Clinical Trial Site 032102
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Quilmes, Buenos Aires, Argentinië, B1878FNR
- Chiesi Clinical Trial Site 032106
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San Fernando, Buenos Aires, Argentinië, 1646
- Chiesi Clinical Trial Site 032116
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San Juan Bautista, Buenos Aires, Argentinië, B1853AIK
- Chiesi Clinical Trial Site 032110
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Vicente López, Buenos Aires, Argentinië, 1602
- Chiesi Clinical Trial Site 032100
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Córdoba Province
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Córdoba, Córdoba Province, Argentinië, X5008HHW
- Chiesi Clinical Trial Site 032111
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Entre Ríos Province
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Concepción del Uruguay, Entre Ríos Province, Argentinië, E3260EPD
- Chiesi Clinical Trial Site 032120
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Santa Fe Province
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Rosario, Santa Fe Province, Argentinië, 2000
- Chiesi Clinical Trial Site 032101
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Rosario, Santa Fe Province, Argentinië, S2121
- Chiesi Clinical Trial Site 032132
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentinië, T4000
- Chiesi Clinical Trial Site 032117
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Gabrovo, Bulgarije
- Chiesi Clinical Trial Site 100125
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Haskovo, Bulgarije
- Chiesi Clinical Trial Site 100109
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Kozloduy, Bulgarije, 3320
- Chiesi Clinical Trial Site 100129
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Lovech, Bulgarije
- Chiesi Clinical Trial Site 100111
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Montana, Bulgarije
- Chiesi Clinical Trial Site 100115
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Pleven, Bulgarije, 5808
- Chiesi Clinical Trial Site 100132
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Pleven, Bulgarije
- Chiesi Clinical Trial Site 100101
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Plovdiv, Bulgarije, 4003
- Chiesi Clinical Trial Site 100131
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Plovdiv, Bulgarije
- Chiesi Clinical Trial Site 100102
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Plovdiv, Bulgarije
- Chiesi Clinical Trial Site 100126
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Razgrad, Bulgarije, 7200
- Chiesi Clinical Trial Site 100128
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Rousse, Bulgarije
- Chiesi Clinical Trial Site 100104
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Rousse, Bulgarije
- Chiesi Clinical Trial Site 100113
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Sofia, Bulgarije
- Chiesi Clinical Trial Site 100100
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Sofia, Bulgarije
- Chiesi Clinical Trial Site 100110
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Sofia, Bulgarije
- Chiesi Clinical Trial Site 100112
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Sofia, Bulgarije
- Chiesi Clinical Trial Site 100116
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Sofia, Bulgarije
- Chiesi Clinical Trial Site 100117
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Sofia, Bulgarije
- Chiesi Clinical Trial Site 100118
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Sofia, Bulgarije
- Chiesi Clinical Trial Site 100119
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Sofia, Bulgarije
- Chiesi Clinical Trial Site 100121
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Sofia, Bulgarije
- Chiesi Clinical Trial Site 100123
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Sofia, Bulgarije
- Chiesi Clinical Trial Site 100124
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Sofia, Bulgarije
- Chiesi Clinical Trial Site 100127
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Stara Zagora, Bulgarije
- Chiesi Clinical Trial Site 100103
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Stara Zagora, Bulgarije
- Chiesi Clinical Trial Site 100107
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Varna, Bulgarije, 9020
- Chiesi Clinical Trial Site 100130
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Veliko Tarnovo, Bulgarije
- Chiesi Clinical Trial Site 100122
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Vidin, Bulgarije
- Chiesi Clinical Trial Site 100106
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Vidin, Bulgarije
- Chiesi Clinical Trial Site 100114
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Alberta
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Edmonton, Alberta, Canada, T5A 4L8
- Chiesi Clinical Trial Site 124103
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Sherwood Park, Alberta, Canada, T8H 0N2
- Chiesi Clinical Trial Site 124105
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Ontario
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Burlington, Ontario, Canada, L7N 3V2
- Chiesi Clinical Trial Site 124102
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Greater Sudbury, Ontario, Canada, P3C 1X3
- Chiesi Clinical Trial Site 124104
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Windsor, Ontario, Canada, N8X 1T3
- Chiesi Clinical Trial Site 124100
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Quebec
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Trois-Rivières, Quebec, Canada, G8T 7A1
- Chiesi Clinical Trial Site 124106
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Debrecen, Hongarije
- Chiesi Clinical Trial Site 348118
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Hajdúnánás, Hongarije
- Chiesi Clinical Trial Site 348112
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Hatvan, Hongarije
- Chiesi Clinical Trial Site 348116
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Monor, Hongarije
- Chiesi Clinical Trial Site 348103
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Sellye, Hongarije, 7960
- Chiesi Clinical Trial Site 348125
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BA
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Komló, BA, Hongarije, 7300
- Chiesi Clinical Trial Site 348121
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Pécs, BA, Hongarije, 7626
- Chiesi Clinical Trial Site 348122
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GS
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Csorna, GS, Hongarije, 9300
- Chiesi Clinical Trial Site 348124
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JN
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Szolnok, JN, Hongarije, 5000
- Chiesi Clinical Trial Site 348126
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Nógrád megye
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Balassagyarmat, Nógrád megye, Hongarije
- Chiesi Clinical Trial Site 348107
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Pest County
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Gödöllő, Pest County, Hongarije
- Chiesi Clinical Trial Site 348120
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Szabolcs-Szatmár-Bereg
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Nyíregyháza, Szabolcs-Szatmár-Bereg, Hongarije
- Chiesi Clinical Trial Site 348104
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Nyíregyháza, Szabolcs-Szatmár-Bereg, Hongarije
- Chiesi Clinical Trial Site 348109
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Vas County
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Szombathely, Vas County, Hongarije
- Chiesi Clinical Trial Site 348105
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Chihuahua City, Mexico, 31217
- Chiesi Clinical Trial Site 484116
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Chihuahua City, Mexico
- Chiesi Clinical Trial Site 484105
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Chihuahua City, Mexico
- Chiesi Clinical Trial Site 484109
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Tlalpan, Mexico
- Chiesi Clinical Trial Site 484108
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Estado de Baja California
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Tijuana, Estado de Baja California, Mexico
- Chiesi Clinical Trial Site 484110
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Jalisco
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Guadalajara, Jalisco, Mexico, 44610
- Chiesi Clinical Trial Site 484113
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Guadalajara, Jalisco, Mexico
- Chiesi Clinical Trial Site 484100
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Guadalajara, Jalisco, Mexico
- Chiesi Clinical Trial Site 484102
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Guadalajara, Jalisco, Mexico
- Chiesi Clinical Trial Site 484104
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Guadalajara, Jalisco, Mexico
- Chiesi Clinical Trial Site 484106
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Guadalajara, Jalisco, Mexico
- Chiesi Clinical Trial Site 484112
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Guadalupe, Jalisco, Mexico, 44200
- Chiesi Clinical Trial Site 484115
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Mexico City
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Cuauhtémoc, Mexico City, Mexico
- Chiesi Clinical Trial Site 484103
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Michoacán
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Morelia, Michoacán, Mexico
- Chiesi Clinical Trial Site 484107
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Nuevo León
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Monterrey, Nuevo León, Mexico
- Chiesi Clinical Trial Site 484101
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Monterrey, Nuevo León, Mexico
- Chiesi Clinical Trial Site 484111
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Bialystok, Polen, 15-003
- Chiesi Clinical Trial Site 616125
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Bialystok, Polen
- Chiesi Clinical Trial Site 616119
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Giżycko, Polen
- Chiesi Clinical Trial Site 616100
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Grudziądz, Polen
- Chiesi Clinical Trial Site 616113
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Katowice, Polen
- Chiesi Clinical Trial Site 616116
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Krakow, Polen, 30-149
- Chiesi Clinical Trial Site 616122
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Krakow, Polen
- Chiesi Clinical Trial Site 616106
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Krakow, Polen
- Chiesi Clinical Trial Site 616109
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Krakow, Polen
- Chiesi Clinical Trial Site 616118
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Lodz, Polen
- Chiesi Clinical Trial Site 616103
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Olsztyn, Polen
- Chiesi Clinical Trial Site 616128
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Ostrowiec, Polen
- Chiesi Clinical Trial Site 616117
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Ostróda, Polen
- Chiesi Clinical Trial Site 616105
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Poznan, Polen, 60-214
- Chiesi Clinical Trial Site 616123
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Poznan, Polen
- Chiesi Clinical Trial Site 616107
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Poznan, Polen
- Chiesi Clinical Trial Site 616110
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Rzeszów, Polen
- Chiesi Clinical Trial Site 616108
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Skierniewice, Polen
- Chiesi Clinical Trial Site 616114
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Skorzewo, Polen, 60-185
- Chiesi Clinical Trial Site 616120
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Sosnowiec, Polen
- Chiesi Clinical Trial Site 616102
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Tarnów, Polen
- Chiesi Clinical Trial Site 616111
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Torun, Polen
- Chiesi Clinical Trial Site 616115
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Warsaw, Polen, 00-215
- Chiesi Clinical Trial Site 616127
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Wroclaw, Polen, 54-239
- Chiesi Clinical Trial Site 616126
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Wroclaw, Polen
- Chiesi Clinical Trial Site 616104
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Wroclaw, Polen
- Chiesi Clinical Trial Site 616112
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Zawadzkie, Polen
- Chiesi Clinical Trial Site 616101
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Guaynabo, Puerto Rico, 00968
- Chiesi Clinical Trial Site 840393
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Bacau, Roemenië, 600252
- Chiesi Clinical Trial Site 642109
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Bragadiru, Roemenië, 077025
- Chiesi Clinical Trial Site 642106
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Brasov, Roemenië, 500283
- Chiesi Clinical Trial Site 642117
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Bucharest, Roemenië, 020125
- Chiesi Clinical Trial Site 642103
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Bucharest, Roemenië, 11025
- Chiesi Clinical Trial Site 642113
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Bucharest, Roemenië, 012071
- Chiesi Clinical Trial Site 642108
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Caracal, Roemenië, 235200
- Chiesi Clinical Trial Site 642115
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Cluj-Napoca, Roemenië, 400275
- Chiesi Clinical Trial Site 642111
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Constanța, Roemenië, 900433
- Chiesi Clinical Trial Site 642105
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Craiova, Roemenië, 200515
- Chiesi Clinical Trial Site 642110
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Craiova, Roemenië, 200515
- Chiesi Clinical Trial Site 642118
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Iași, Roemenië, 700141
- Chiesi Clinical Trial Site 642101
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Reșca, Roemenië, 237143
- Chiesi Clinical Trial Site 642114
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Satu Mare, Roemenië, 44055
- Chiesi Clinical Trial Site 642112
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Timișoara, Roemenië, 300134
- Chiesi Clinical Trial Site 642116
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Bihor County
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Oradea, Bihor County, Roemenië, 410169
- Chiesi Clinical Trial Site 642102
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Cluj
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Cluj-Napoca, Cluj, Roemenië, 400371
- Chiesi Clinical Trial Site 642104
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Hunedoara County
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Deva, Hunedoara County, Roemenië, 330162
- Chiesi Clinical Trial Site 642120
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Ilfov
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Bragadiru, Ilfov, Roemenië, 077025
- Chiesi Clinical Trial Site 642107
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Timiș County
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Timișoara, Timiș County, Roemenië, 300336
- Chiesi Clinical Trial Site 642119
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Brandýs nad Labem, Tsjechië
- Chiesi Clinical Trial Site 203101
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Jindřichův Hradec, Tsjechië
- Chiesi Clinical Trial Site 203107
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Miroslav, Tsjechië
- Chiesi Clinical Trial Site 203109
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Prague, Tsjechië, 11000
- Chiesi Clinical Trial Site 203116
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Prague, Tsjechië, 140 00
- Chiesi Clinical Trial Site 203115
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Prague, Tsjechië
- Chiesi Clinical Trial Site 203114
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Rokycany, Tsjechië
- Chiesi Clinical Trial Site 203112
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Strakonice, Tsjechië
- Chiesi Clinical Trial Site 203108
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Teplice, Tsjechië
- Chiesi Clinical Trial Site 203104
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Tábor, Tsjechië
- Chiesi Clinical Trial Site 203105
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Varnsdorf, Tsjechië
- Chiesi Clinical Trial Site 203110
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35215-7502
- Chiesi Clinical Trial Site 840350
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Dothan, Alabama, Verenigde Staten, 36303
- Chiesi Clinical Trial Site 840186
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Foley, Alabama, Verenigde Staten, 36535
- Chiesi Clinical Trial Site 840258
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Jasper, Alabama, Verenigde Staten, 35501
- Chiesi Clinical Trial Site 840279
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Mobile, Alabama, Verenigde Staten, 36608
- Chiesi Clinical Trial Site 840433
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Montgomery, Alabama, Verenigde Staten, 36106
- Chiesi Clinical Trial Site 840206
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Muscle Shoals, Alabama, Verenigde Staten, 35661
- Chiesi Clinical Trial Site 840249
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Arizona
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Chandler, Arizona, Verenigde Staten, 85224
- Chiesi Clinical Trial Site 840406
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Peoria, Arizona, Verenigde Staten, 85381
- Chiesi Clinical Trial Site 840402
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Tucson, Arizona, Verenigde Staten, 85741
- Chiesi Clinical Trial Site 840349
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California
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Covina, California, Verenigde Staten, 91723
- Chiesi Clinical Trial Site 840404
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Escondido, California, Verenigde Staten, 92025
- Chiesi Clinical Trial Site 840209
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La Palma, California, Verenigde Staten, 90623
- Chiesi Clinical Trial Site 840427
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Lomita, California, Verenigde Staten, 90717
- Chiesi Clinical Trial Site 840358
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Newport Beach, California, Verenigde Staten, 92663
- Chiesi Clinical Trial Site 840173
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Northridge, California, Verenigde Staten, 91324
- Chiesi Clinical Trial Site 840208
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Northridge, California, Verenigde Staten, 91324
- Chiesi Clinical Trial Site 840277
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Redding, California, Verenigde Staten, 96001
- Chiesi Clinical Trial Site 840364
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Sacramento, California, Verenigde Staten, 95821
- Chiesi Clinical Trial Site 840226
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Sacramento, California, Verenigde Staten, 95823
- Chiesi Clinical Trial Site 840405
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San Diego, California, Verenigde Staten, 92120
- Chiesi Clinical Trial Site 840107
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Santa Ana, California, Verenigde Staten, 92705
- Chiesi Clinical Trial Site 840373
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Upland, California, Verenigde Staten, 91786
- Chiesi Clinical Trial Site 840164
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West Covina, California, Verenigde Staten, 91790
- Chiesi Clinical Trial Site 840174
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Westminster, California, Verenigde Staten, 92683
- Chiesi Clinical Trial Site 840144
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Colorado
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Aurora, Colorado, Verenigde Staten, 80014
- Chiesi Clinical Trial Site 840441
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Boulder, Colorado, Verenigde Staten, 80302
- Chiesi Clinical Trial Site 840229
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Connecticut
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Norwalk, Connecticut, Verenigde Staten, 06586
- Chiesi Clinical Trial Site 840399
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Florida
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Altamonte Springs, Florida, Verenigde Staten, 32701
- Chiesi Clinical Trial Site 840116
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Aventura, Florida, Verenigde Staten, 33180
- Chiesi Clinical Trial Site 840268
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Brandon, Florida, Verenigde Staten, 33511
- Chiesi Clinical Trial Site 840192
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Brooksville, Florida, Verenigde Staten, 34613
- Chiesi Clinical Trial Site 840310
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Chiefland, Florida, Verenigde Staten, 32626
- Chiesi Clinical Trial Site 840240
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Clearwater, Florida, Verenigde Staten, 33756
- Chiesi Clinical Trial Site 840153
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Coral Gables, Florida, Verenigde Staten, 33134
- Chiesi Clinical Trial Site 840272
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Coral Gables, Florida, Verenigde Staten, 33134
- Chiesi Clinical Trial Site 840304
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Cutler Bay, Florida, Verenigde Staten, 33157
- Chiesi Clinical Trial Site 840193
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Cutler Bay, Florida, Verenigde Staten, 33189
- Chiesi Clinical Trial Site 840311
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Cutler Bay, Florida, Verenigde Staten, 33189
- Chiesi Clinical Trial Site 840335
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Daytona Beach, Florida, Verenigde Staten, 32117
- Chiesi Clinical Trial Site 840141
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DeLand, Florida, Verenigde Staten, 32720
- Chiesi Clinical Trial Site 840133
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Doral, Florida, Verenigde Staten, 33122
- Chiesi Clinical Trial Site 840269
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Hialeah, Florida, Verenigde Staten, 33010
- Chiesi Clinical Trial Site 840303
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Hialeah, Florida, Verenigde Staten, 33012
- Chiesi Clinical Trial Site 840163
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Hialeah, Florida, Verenigde Staten, 33012
- Chiesi Clinical Trial Site 840165
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Hialeah, Florida, Verenigde Staten, 33012
- Chiesi Clinical Trial Site 840238
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Hialeah, Florida, Verenigde Staten, 33012
- Chiesi Clinical Trial Site 840265
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Hialeah, Florida, Verenigde Staten, 33015
- Chiesi Clinical Trial Site 840241
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Hialeah, Florida, Verenigde Staten, 33015
- Chiesi Clinical Trial Site 840253
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Hialeah, Florida, Verenigde Staten, 33016
- Chiesi Clinical Trial Site 840184
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Hialeah, Florida, Verenigde Staten, 33016
- Chiesi Clinical Trial Site 840267
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Hialeah Gardens, Florida, Verenigde Staten, 33016
- Chiesi Clinical Trial Site 840354
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Hialeah Gardens, Florida, Verenigde Staten, 33066
- Chiesi Clinical Trial Site 840256
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Kissimmee, Florida, Verenigde Staten, 34741
- Chiesi Clinical Trial Site 840200
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Lakeland, Florida, Verenigde Staten, 33803
- Chiesi Clinical Trial Site 840232
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Leesburg, Florida, Verenigde Staten, 34748
- Chiesi Clinical Trial Site 840113
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Miami, Florida, Verenigde Staten, 33122
- Chiesi Clinical Trial Site 840372
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Miami, Florida, Verenigde Staten, 33125
- Chiesi Clinical Trial Site 840137
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Miami, Florida, Verenigde Staten, 33125
- Chiesi Clinical Trial Site 840289
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Miami, Florida, Verenigde Staten, 33125
- Chiesi Clinical Trial Site 840377
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Miami, Florida, Verenigde Staten, 33125
- Chiesi Clinical Trial Site 840387
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Miami, Florida, Verenigde Staten, 33126
- Chiesi Clinical Trial Site 840326
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Miami, Florida, Verenigde Staten, 33133
- Chiesi Clinical Trial Site 840175
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Miami, Florida, Verenigde Staten, 33133
- Chiesi Clinical Trial Site 840346
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Miami, Florida, Verenigde Staten, 33134
- Chiesi Clinical Trial Site 840347
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Miami, Florida, Verenigde Staten, 33135
- Chiesi Clinical Trial Site 840205
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Miami, Florida, Verenigde Staten, 33135
- Chiesi Clinical Trial Site 840247
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Miami, Florida, Verenigde Staten, 33135
- Chiesi Clinical Trial Site 840341
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Miami, Florida, Verenigde Staten, 33144
- Chiesi Clinical Trial Site 840148
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Miami, Florida, Verenigde Staten, 33144
- Chiesi Clinical Trial Site 840239
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Miami, Florida, Verenigde Staten, 33144
- Chiesi Clinical Trial Site 840312
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Miami, Florida, Verenigde Staten, 33144
- Chiesi Clinical Trial Site 840355
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Miami, Florida, Verenigde Staten, 33144
- Chiesi Clinical Trial Site 840388
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Miami, Florida, Verenigde Staten, 33155
- Chiesi Clinical Trial Site 840237
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Miami, Florida, Verenigde Staten, 33155
- Chiesi Clinical Trial Site 840261
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Miami, Florida, Verenigde Staten, 33155
- Chiesi Clinical Trial Site 840262
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Miami, Florida, Verenigde Staten, 33155
- Chiesi Clinical Trial Site 840280
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Miami, Florida, Verenigde Staten, 33165
- Chiesi Clinical Trial Site 840178
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Miami, Florida, Verenigde Staten, 33165
- Chiesi Clinical Trial Site 840292
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Miami, Florida, Verenigde Staten, 33166
- Chiesi Clinical Trial Site 840202
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Miami, Florida, Verenigde Staten, 33169
- Chiesi Clinical Trial Site 840275
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Miami, Florida, Verenigde Staten, 33173
- Chiesi Clinical Trial Site 840122
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Miami, Florida, Verenigde Staten, 33173
- Chiesi Clinical Trial Site 840352
-
Miami, Florida, Verenigde Staten, 33174
- Chiesi Clinical Trial Site 840235
-
Miami, Florida, Verenigde Staten, 33174
- Chiesi Clinical Trial Site 840360
-
Miami, Florida, Verenigde Staten, 33174
- Chiesi Clinical Trial Site 840381
-
Miami, Florida, Verenigde Staten, 33175
- Chiesi Clinical Trial Site 840243
-
Miami, Florida, Verenigde Staten, 33175
- Chiesi Clinical Trial Site 840244
-
Miami, Florida, Verenigde Staten, 33175
- Chiesi Clinical Trial Site 840257
-
Miami, Florida, Verenigde Staten, 33175
- Chiesi Clinical Trial Site 840380
-
Miami, Florida, Verenigde Staten, 33175
- Chiesi Clinical Trial Site 840382
-
Miami, Florida, Verenigde Staten, 33176
- Chiesi Clinical Trial Site 840367
-
Miami, Florida, Verenigde Staten, 33186
- Chiesi Clinical Trial Site 840162
-
Miami, Florida, Verenigde Staten, 33186
- Chiesi Clinical Trial Site 840166
-
Miami, Florida, Verenigde Staten, 33186
- Chiesi Clinical Trial Site 840370
-
Miami, Florida, Verenigde Staten, 33186
- Chiesi Clinical Trial Site 840392
-
Miami Beach, Florida, Verenigde Staten, 33141
- Chiesi Clinical Trial Site 840319
-
Miami Lakes, Florida, Verenigde Staten, 33014
- Chiesi Clinical Trial Site 840328
-
Miami Lakes, Florida, Verenigde Staten, 33014
- Chiesi Clinical Trial Site 840378
-
Miami Lakes, Florida, Verenigde Staten, 33016
- Chiesi Clinical Trial Site 840288
-
Miami Lakes, Florida, Verenigde Staten, 33016
- Chiesi Clinical Trial Site 840385
-
Miami Lakes, Florida, Verenigde Staten, 33144
- Chiesi Clinical Trial Site 840353
-
Mt. Dora, Florida, Verenigde Staten, 32757
- Chiesi Clinical Trial Site 840140
-
New Port Richey, Florida, Verenigde Staten, 34652
- Chiesi Clinical Trial Site 840263
-
North Miami, Florida, Verenigde Staten, 33161
- Chiesi Clinical Trial Site 840132
-
North Miami Beach, Florida, Verenigde Staten, 33160
- Chiesi Clinical Trial Site 840161
-
Orlando, Florida, Verenigde Staten, 32807
- Chiesi Clinical Trial Site 840255
-
Orlando, Florida, Verenigde Staten, 32822
- Chiesi Clinical Trial Site 840110
-
Orlando, Florida, Verenigde Staten, 32825
- Chiesi Clinical Trial Site 840125
-
Palmetto Bay, Florida, Verenigde Staten, 33157
- Chiesi Clinical Trial Site 840121
-
Pembroke Pines, Florida, Verenigde Staten, 33024
- Chiesi Clinical Trial Site 840196
-
Pembroke Pines, Florida, Verenigde Staten, 33024
- Chiesi Clinical Trial Site 840198
-
Plantation, Florida, Verenigde Staten, 33317
- Chiesi Clinical Trial Site 840363
-
Plantation, Florida, Verenigde Staten, 33317
- Chiesi Clinical Trial Site 840371
-
Pompano Beach, Florida, Verenigde Staten, 33064
- Chiesi Clinical Trial Site 840252
-
Port Charlotte, Florida, Verenigde Staten, 33952
- Chiesi Clinical Trial Site 840105
-
Sarasota, Florida, Verenigde Staten, 34239
- Chiesi Clinical Trial Site 840294
-
St. Petersburg, Florida, Verenigde Staten, 33704
- Chiesi Clinical Trial Site 840291
-
Tampa, Florida, Verenigde Staten, 33607
- Chiesi Clinical Trial Site 840313
-
Tampa, Florida, Verenigde Staten, 33607
- Chiesi Clinical Trial Site 840356
-
Tampa, Florida, Verenigde Staten, 33607
- Chiesi Clinical Trial Site 840379
-
Tampa, Florida, Verenigde Staten, 33613
- Chiesi Clinical Trial Site 840131
-
Tampa, Florida, Verenigde Staten, 33614
- Chiesi Clinical Trial Site 840324
-
Tampa, Florida, Verenigde Staten, 33634
- Chiesi Clinical Trial Site 840309
-
The Villages, Florida, Verenigde Staten, 32162
- Chiesi Clinical Trial Site 840210
-
Winter Park, Florida, Verenigde Staten, 32789
- Chiesi Clinical Trial Site 840129
-
-
Georgia
-
Adairsville, Georgia, Verenigde Staten, 30103
- Chiesi Clinical Trial Site 840223
-
Columbus, Georgia, Verenigde Staten, 31904
- Chiesi Clinical Trial Site 840218
-
Columbus, Georgia, Verenigde Staten, 31904
- Chiesi Clinical Trial Site 840414
-
Cordele, Georgia, Verenigde Staten, 31015
- Chiesi Clinical Trial Site 840437
-
Lawrenceville, Georgia, Verenigde Staten, 30044
- Chiesi Clinical Trial Site 840390
-
Lawrenceville, Georgia, Verenigde Staten, 30046
- Chiesi Clinical Trial Site 840227
-
Rincon, Georgia, Verenigde Staten, 31326
- Chiesi Clinical Trial Site 840138
-
Stonecrest, Georgia, Verenigde Staten, 30038
- Chiesi Clinical Trial Site 840417
-
Union City, Georgia, Verenigde Staten, 30291
- Chiesi Clinical Trial Site 840383
-
-
Illinois
-
Chicago, Illinois, Verenigde Staten, 60602
- Chiesi Clinical Trial Site 840321
-
Chicago Ridge, Illinois, Verenigde Staten, 60415
- Chiesi Clinical Trial Site 840365
-
-
Indiana
-
Hammond, Indiana, Verenigde Staten, 46324
- Chiesi Clinical Trial Site 840407
-
Valparaiso, Indiana, Verenigde Staten, 76383
- Chiesi Clinical Trial Site 840108
-
-
Iowa
-
Council Bluffs, Iowa, Verenigde Staten, 51503
- Chiesi Clinical Trial Site 840318
-
-
Louisiana
-
Crowley, Louisiana, Verenigde Staten, 70526
- Chiesi Clinical Trial Site 840207
-
Zachary, Louisiana, Verenigde Staten, 70791
- Chiesi Clinical Trial Site 840436
-
-
Maine
-
Bangor, Maine, Verenigde Staten, 04401
- Chiesi Clinical Trial Site 840451
-
-
Maryland
-
Baltimore, Maryland, Verenigde Staten, 21237
- Chiesi Clinical Trial Site 840447
-
Baltimore, Maryland, Verenigde Staten, 21287
- Chiesi Clinical Trial Site 840376
-
Westminster, Maryland, Verenigde Staten, 21157
- Chiesi Clinical Trial Site 840199
-
-
Massachusetts
-
Fall River, Massachusetts, Verenigde Staten, 02723
- Chiesi Clinical Trial Site 840214
-
New Bedford, Massachusetts, Verenigde Staten, 02740
- Chiesi Clinical Trial Site 840322
-
North Dartmouth, Massachusetts, Verenigde Staten, 02747
- Chiesi Clinical Trial site 840250
-
-
Michigan
-
Dearborn, Michigan, Verenigde Staten, 48124
- Chiesi Clinical Trial Site 840325
-
Dearborn, Michigan, Verenigde Staten, 48126
- Chiesi Clinical Trial Site 840400
-
Farmington Hills, Michigan, Verenigde Staten, 48336
- Chiesi Clinical Trial Site 840183
-
Flint, Michigan, Verenigde Staten, 48504
- Chiesi Clinical Trial Site 840340
-
Flint, Michigan, Verenigde Staten, 48532
- Chiesi Clinical Trial Site 840401
-
Novi, Michigan, Verenigde Staten, 48375
- Chiesi Clinical Trial Site 840345
-
Southfield, Michigan, Verenigde Staten, 48034
- Chiesi Clinical Trial Site 840287
-
Southfield, Michigan, Verenigde Staten, 48075
- Chiesi Clinical Trial Site 840415
-
-
Mississippi
-
Fayette, Mississippi, Verenigde Staten, 39069
- Chiesi Clinical Trial Site 840444
-
Ridgeland, Mississippi, Verenigde Staten, 39157
- Chiesi Clinical Trial Site 840448
-
-
Missouri
-
Chesterfield, Missouri, Verenigde Staten, 63017
- Chiesi Clinical Trial Site 840278
-
Columbia, Missouri, Verenigde Staten, 65203
- Chiesi Clinical Trial Site 840155
-
Richmond Heights, Missouri, Verenigde Staten, 63117
- Chiesi Clinical Trial Site 840316
-
Saint Charles, Missouri, Verenigde Staten, 63301
- Chiesi Clinical Trial Site 840150
-
St Louis, Missouri, Verenigde Staten, 63123
- Chiesi Clinical Trial Site 840282
-
St Louis, Missouri, Verenigde Staten, 63141
- Chiesi Clinical Trial Site 840123
-
St Louis, Missouri, Verenigde Staten, 63141
- Chiesi Clinical Trial Site 840142
-
-
Montana
-
Missoula, Montana, Verenigde Staten, 59808
- Chiesi Clinical Trial Site 840273
-
-
Nebraska
-
Lincoln, Nebraska, Verenigde Staten, 68506
- Chiesi Clinical Trial Site 840281
-
Omaha, Nebraska, Verenigde Staten, 68114
- Chiesi Clinical Trial Site 840329
-
-
Nevada
-
Las Vegas, Nevada, Verenigde Staten, 840213
- Chiesi Clinical Trial Site 840213
-
Las Vegas, Nevada, Verenigde Staten, 89106
- Chiesi Clinical Trial Site 840285
-
Las Vegas, Nevada, Verenigde Staten, 89123
- Chiesi Clinical Trial Site 840299
-
-
New Hampshire
-
Portsmouth, New Hampshire, Verenigde Staten, 03810
- Chiesi Clinical Trial Site 840338
-
-
New Jersey
-
Berlin, New Jersey, Verenigde Staten, 08009
- Chiesi Clinical Trial Site 840297
-
Toms River, New Jersey, Verenigde Staten, 08755
- Chiesi Clinical Trial Site 840333
-
-
New York
-
Binghamton, New York, Verenigde Staten, 13905
- Chiesi Clinical Trial Site 840330
-
Brooklyn, New York, Verenigde Staten, 11235
- Chiesi Clinical Trial Site 840397
-
Buffalo, New York, Verenigde Staten, 14201
- Chiesi Clinical Trial Site 840254
-
Buffalo, New York, Verenigde Staten, 14203
- Chiesi Clinical Trial Site 840307
-
Flushing, New York, Verenigde Staten, 11355
- Chiesi Clinical Trial Site 840368
-
New Windsor, New York, Verenigde Staten, 12553
- Chiesi Clinical Trial Site 840362
-
The Bronx, New York, Verenigde Staten, 10455
- Chiesi Clinical Trial Site 840128
-
-
North Carolina
-
Charlotte, North Carolina, Verenigde Staten, 28207
- Chiesi Clinical Trial Site 840215
-
Charlotte, North Carolina, Verenigde Staten, 28210
- Chiesi Clinical Trial Site 840366
-
Charlotte, North Carolina, Verenigde Staten, 28277
- Chiesi Clinical Trial Site 840158
-
Denver, North Carolina, Verenigde Staten, 28037
- Chiesi Clinical Trial Site 840409
-
Durham, North Carolina, Verenigde Staten, 27705
- Chiesi Clinical Trial Site 840403
-
Gastonia, North Carolina, Verenigde Staten, 28054
- Chiesi Clinical Trial Site 840428
-
Huntersville, North Carolina, Verenigde Staten, 28078
- Chiesi Clinical Trial Site 840236
-
Monroe, North Carolina, Verenigde Staten, 28112
- Chiesi Clinical Trial Site 840259
-
Morgantown, North Carolina, Verenigde Staten, 28655
- Chiesi Clinical Trial Site 840440
-
New Bern, North Carolina, Verenigde Staten, 28562
- Chiesi Clinical Trial Site 840194
-
Raleigh, North Carolina, Verenigde Staten, 27607
- Chiesi Clinical Trial Site 840120
-
Raleigh, North Carolina, Verenigde Staten, 27607
- Chiesi Clinical Trial Site 840438
-
Raleigh, North Carolina, Verenigde Staten, 27617
- Chiesi Clinical Trial Site 840429
-
Rocky Mount, North Carolina, Verenigde Staten, 27804
- Chiesi Clinical Trial Site 840112
-
Shelby, North Carolina, Verenigde Staten, 28150
- Chiesi Clinical Trial Site 840135
-
Wilmington, North Carolina, Verenigde Staten, 28403
- Chiesi Clinical Trial Site 840189
-
Winston-Salem, North Carolina, Verenigde Staten, 27103
- Chiesi Clinical Trial Site 840412
-
-
Ohio
-
Akron, Ohio, Verenigde Staten, 44313
- Chiesi Clinical Trial Site 840445
-
Cincinnati, Ohio, Verenigde Staten, 45231
- Chiesi Clinical Trial Site 840104
-
Cincinnati, Ohio, Verenigde Staten, 45242
- Chiesi Clinical Trial Site 840357
-
Columbus, Ohio, Verenigde Staten, 43215
- Chiesi Clinical Trial Site 840124
-
Dayton, Ohio, Verenigde Staten, 45424
- Chiesi Clinical Trial Site 840426
-
Kettering, Ohio, Verenigde Staten, 45439
- Chiesi Clinical Trial Site 840302
-
Maumee, Ohio, Verenigde Staten, 43537
- Chiesi Clinical Trial Site 840233
-
Middleburg Heights, Ohio, Verenigde Staten, 44130
- Chiesi Clinical Trial Site 840167
-
Toledo, Ohio, Verenigde Staten, 43617
- Chiesi Clinical Trial Site 840157
-
-
Oregon
-
Medford, Oregon, Verenigde Staten, 97504
- Chiesi Clinical Trial Site 840203
-
-
Pennsylvania
-
Beaver, Pennsylvania, Verenigde Staten, 15009
- Chiesi Clinical Trial Site 840300
-
DuBois, Pennsylvania, Verenigde Staten, 15801
- Chiesi Clinical Trial Site 840308
-
Jenkintown, Pennsylvania, Verenigde Staten, 19046
- Chiesi Clinical Trial Site 840156
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15236
- Chiesi Clinical Trial Site 840327
-
Scotland, Pennsylvania, Verenigde Staten, 15683
- Chiesi Clinical Trial Site 840418
-
Smithfield, Pennsylvania, Verenigde Staten, 15478
- Chiesi Clinical Trial Site 840419
-
-
Rhode Island
-
Cranston, Rhode Island, Verenigde Staten, 02920
- Chiesi Clinical Trial Site 840450
-
Cumberland, Rhode Island, Verenigde Staten, 02864
- Chiesi Clinical Trial Site 840332
-
-
South Carolina
-
Anderson, South Carolina, Verenigde Staten, 29621
- Chiesi Clinical Trial Site 840222
-
Anderson, South Carolina, Verenigde Staten, 29621
- Chiesi Clinical Trial Site 840435
-
Charleston, South Carolina, Verenigde Staten, 29406
- Chiesi Clinical Trial Site 840431
-
Columbia, South Carolina, Verenigde Staten, 29201
- Chiesi Clinical Trial Site 840334
-
Columbia, South Carolina, Verenigde Staten, 29204
- Chiesi Clinical Trial Site 840130
-
Columbia, South Carolina, Verenigde Staten, 29223
- Chiesi Clinical Trial Site 840430
-
Fort Mill, South Carolina, Verenigde Staten, 29707
- Chiesi Clinical Trial Site 840211
-
Gaffney, South Carolina, Verenigde Staten, 29340
- Chiesi Clinical Trial Site 840182
-
Greenville, South Carolina, Verenigde Staten, 29615
- Chiesi Clinical Trial Site 840111
-
Lancaster, South Carolina, Verenigde Staten, 29720
- Chiesi Clinical Trial Site 840420
-
Mauldin, South Carolina, Verenigde Staten, 29662
- Chiesi Clinical Trial Site 840386
-
Rock Hill, South Carolina, Verenigde Staten, 29732
- Chiesi Clinical Trial Site 840100
-
Spartanburg, South Carolina, Verenigde Staten, 29303
- Chiesi Clinical Trial Site 840375
-
Union, South Carolina, Verenigde Staten, 29379
- Chiesi Clinical Trial Site 840106
-
West Columbia, South Carolina, Verenigde Staten, 29169
- Chiesi Clinical Trial Site 840295
-
-
South Dakota
-
Rapid City, South Dakota, Verenigde Staten, 57702
- Chiesi Clinical Trial Site 840398
-
-
Tennessee
-
Chattanooga, Tennessee, Verenigde Staten, 37404
- Chiesi Clinical Trial Site 840305
-
Franklin, Tennessee, Verenigde Staten, 37067
- Chiesi Clinical Trial Site 840351
-
Johnson City, Tennessee, Verenigde Staten, 37601
- Chiesi Clinical Trial Site 840306
-
Knoxville, Tennessee, Verenigde Staten, 37909
- Chiesi Clinical Trial Site 840171
-
Nashville, Tennessee, Verenigde Staten, 37203
- Chiesi Clinical Trial Site 840361
-
Tullahoma, Tennessee, Verenigde Staten, 37388
- Chiesi Clinical Trial Site 840271
-
-
Texas
-
Baytown, Texas, Verenigde Staten, 77521
- Chiesi Clinical Trial Site 840101
-
Boerne, Texas, Verenigde Staten, 78006
- Chiesi Clinical Trial Site 840114
-
Cypress, Texas, Verenigde Staten, 77429
- Chiesi Clinical Trial Site 840146
-
Dallas, Texas, Verenigde Staten, 75230
- Chiesi Clinical Trial Site 840413
-
Houston, Texas, Verenigde Staten, 77008
- Chiesi Clinical Trial Site 840284
-
Houston, Texas, Verenigde Staten, 77008
- Chiesi Clinical Trial Site 840411
-
Houston, Texas, Verenigde Staten, 77030
- Chiesi Clinical Trial Site 840389
-
Houston, Texas, Verenigde Staten, 77084
- Chiesi Clinical Trial Site 840185
-
Houston, Texas, Verenigde Staten, 77098
- Chiesi Clinical Trial Site 840224
-
Humble, Texas, Verenigde Staten, 77396
- Chiesi Clinical Trial Site 840408
-
Katy, Texas, Verenigde Staten, 77494
- Chiesi Clinical Trial Site 840102
-
Katy, Texas, Verenigde Staten, 77494
- Chiesi Clinical Trial Site 840274
-
Kerrville, Texas, Verenigde Staten, 78028
- Chiesi Clinical Trial Site 840432
-
Lampasas, Texas, Verenigde Staten, 76550
- Chiesi Clinical Trial Site 840160
-
McAllen, Texas, Verenigde Staten, 78503
- Chiesi Clinical Trial Site 840424
-
McKinney, Texas, Verenigde Staten, 75069
- Chiesi Clinical Trial Site 840119
-
Nederland, Texas, Verenigde Staten, 77627
- Chiesi Clinical Trial Site 840442
-
North Richland Hills, Texas, Verenigde Staten, 76180
- Chiesi Clinical Trial Site 840176
-
Pearland, Texas, Verenigde Staten, 77584
- Chiesi Clinical Trial Site 840283
-
San Antonio, Texas, Verenigde Staten, 78063
- Chiesi Clinical Trial Site 840191
-
San Antonio, Texas, Verenigde Staten, 78215
- Chiesi Clinical Trial Site 840320
-
San Antonio, Texas, Verenigde Staten, 78229
- Chiesi Clinical Trial Site 840410
-
Sherman, Texas, Verenigde Staten, 75092
- Chiesi Clinical Trial Site 840231
-
Sherman, Texas, Verenigde Staten, 75092
- Chiesi Clinical Trial Site 840396
-
Splendora, Texas, Verenigde Staten, 77372
- Chiesi Clinical Trial Site 840394
-
Sugar Land, Texas, Verenigde Staten, 77479
- Chiesi Clinical Trial Site 840221
-
Tomball, Texas, Verenigde Staten, 77375
- Chiesi Clinical Trial Site 840139
-
Tomball, Texas, Verenigde Staten, 77375
- Chiesi Clinical Trial Site 840314
-
-
Vermont
-
Colchester, Vermont, Verenigde Staten, 05446
- Chiesi Clinical Trial Site 840337
-
-
Virginia
-
Manassas, Virginia, Verenigde Staten, 20110
- Chiesi Clinical Trial Site 840264
-
Richmond, Virginia, Verenigde Staten, 23219
- Chiesi Clinical Trial Site 840159
-
Richmond, Virginia, Verenigde Staten, 23226
- Chiesi Clinical Trial Site 840425
-
-
Washington
-
Everett, Washington, Verenigde Staten, 98208
- Chiesi Clinical Trial Site 840423
-
Renton, Washington, Verenigde Staten, 98055
- Chiesi Clinical Trial Site 840342
-
Vancouver, Washington, Verenigde Staten, 98664
- Chiesi Clinical Trial Site 840154
-
-
West Virginia
-
Kingwood, West Virginia, Verenigde Staten, 26537
- Chiesi Clinical Trial Site 840421
-
Morgantown, West Virginia, Verenigde Staten, 26505
- Chiesi Clinical Trial Site 840201
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
40 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
-
Signed and dated written informed consent must be obtained prior to initiating any study-related procedures
-
Outpatient
-
Male or female subjects aged ≥40 years
-
Female subjects:
- WOCBP fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signing of the informed consent form and until the follow-up contact or ii. WOCBP with non-fertile male partners (contraception is not required in this case).
- Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile as per definitions given in Appendix 5). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges)
-
COPD diagnosis for at least 12 months before the screening visit in accordance with the definition by the GOLD 2020 Report
-
Current or ex-smokers who quit smoking at least 6 months prior to screening with a smoking history of at least 10 pack-years [pack-years = (number of cigarettes per day x number of years)/20]
-
COPD Assessment Test (CAT) score ≥10
-
A pre- and post-bronchodilator FEV1/FVC ratio <0.70 at screening
-
A post-bronchodilator FEV1 <50% predicted normal at screening and a documented history of ≥1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator FEV1 ≥50% and <80% of predicted normal at screening and a documented history of ≥2 moderate COPD exacerbations or ≥1 severe COPD exacerbation in the previous 12 months
-
Subjects receiving daily inhaled maintenance therapy for their COPD, at a stable dose for at least 3 months prior to the screening and randomization visits
-
Documentation (including imagery and report) of chest x-ray (CXR) or CT scan performed within 6 months prior to the screening visit, without evidence of significant abnormalities (other than those related to the presence of COPD).
-
A cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary.
Exclusion Criteria:
-
Female subjects who are pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating
-
Subjects using the following medications prior to the screening visit and during the run-in period:
- Systemic/oral/parenteral corticosteroids in the prior 4 weeks
- Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) or COPD exacerbation in the prior 4 weeks
- Any long-term chronic maintenance use of antibiotic treatment in the prior 4 weeks
- Oral xanthine derivatives (e.g. theophylline) in the prior 7 days
-
A moderate or severe COPD exacerbation or a respiratory tract infection (e.g., pneumonia) that has not resolved ≤14 days prior to the screening visit or during the run-in period
-
Current treatment with non-cardioselective β-blockers
-
Requirement of long term (> 15 hours daily) oxygen therapy
-
Known respiratory disorders other than COPD which may impact the efficacy of the study drug according to investigator's judgement.
-
Lung transplant surgery or lung volume reduction surgery (subjects with lung volume reduction surgery are excluded if the procedure was performed within 1 year before the Screening visit)
-
Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator, would prevent use of anticholinergic agents
-
History of hypersensitivity to M3 receptor antagonists, β2 agonists, corticosteroids or any of the excipients contained in any of the study drugs used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator's judgement
-
Subject has severe, acute or uncontrolled cardiovascular condition (such as but not limited to unstable ischemic heart disease, NYHA Class IV, left ventricular failure, acute myocardial infarction or unstable angina) in the last 6 months
-
An abnormal and clinically significant 12-lead ECG at either the screening or randomization visit. This is characterized as but not limited to any of the following findings:
- Atrial fibrillation (AF) with rapid ventricular response > 120 bpm
- Ventricular tachycardias (sustained, non-sustained [>3 up to 30 sec])
- Evidence of Mobitz Type II second degree or third-degree atrioventricular block
- Prolonged QTcF (>450ms for males, or >470ms for females). This criterion is not applicable for subjects with a pacemaker or permanent AF.
-
Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug according to investigator's judgement
-
Unstable or uncontrolled concurrent disease which may impact the efficacy or safety of the study drug or the subject's participation in the study according to investigator's judgment
-
Malignancy that has not been in complete remission for at least 1 year or any untreated localized carcinomas
-
History of alcohol abuse and/or substance/drug abuse within 12 months prior to the screening visit
-
Receipt of any other investigational drug within 1 month or 5 half-lives (whichever is greater) prior to the screening visit or have been previously randomized in this trial, or are currently participating in another clinical trial
-
Currently in the acute phase of a pulmonary rehabilitation program within 4 weeks before the screening visit or planning to enroll in the acute phase of such a program during the study. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded
-
Mentally or legally incapacitated, or subjects incarcerated as a result of an official or judicial order
-
Major surgery in the 3 months prior to the screening visit or have a planned surgery during the trial
-
Non-satisfactory compliance with the eDiary (<65% or >135%) during the run-in period
-
Subjects requiring the use of spacer device or nebulizer for administration of maintenance COPD therapies.
-
Veins unsuitable for repeat venipuncture
-
Blood donation or blood loss (≥450mL) in the 4 weeks before randomization
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: BDP/FF/GB - CHF 5993
Two inhalations twice daily of BDP/FF/GB (100/6/12.5μg) for a period of 52 weeks via pressurized metered dose inhaler |
Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg
Andere namen:
Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg
Andere namen:
Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg
Andere namen:
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Actieve vergelijker: BDP/FF - CHF 1535
Two inhalations twice daily of BDP/FF (100/6μg) for a period of 52 weeks via pressurized metered dose inhaler |
Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg
Andere namen:
Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Verandering ten opzichte van baseline in pre-dosis ochtend Geforceerd expiratoir volume in de 1e seconde (FEV1) in week 28
Tijdsspanne: Week 28
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Week 28
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Verandering ten opzichte van baseline in 2 uur post-dosis ochtend FEV1 in week 28
Tijdsspanne: Week 28
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Week 28
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Verandering ten opzichte van baseline in pre-dosis ochtend FEV1 bij aangewezen kliniekbezoeken
Tijdsspanne: Week 4, week 10, week 40 en week 52
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Week 4, week 10, week 40 en week 52
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Verandering ten opzichte van baseline in 2 uur post-dosis ochtend FEV1 aangewezen kliniekbezoeken
Tijdsspanne: Dag 1, week 4, week 10, week 40 en week 52
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Dag 1, week 4, week 10, week 40 en week 52
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Verander van pre-dosis naar 2 uur post-dosis ochtend FEV1 bij aangewezen kliniekbezoeken
Tijdsspanne: Dag 1, Week 4, Week 10, Week 28, Week 40 en Week 52
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Dag 1, Week 4, Week 10, Week 28, Week 40 en Week 52
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FEV1-respons (verandering ten opzichte van baseline in pre-dosis ochtend FEV1 ≥100 ml) bij aangewezen kliniekbezoeken
Tijdsspanne: Dag 1, Week 4, Week 10, Week 28, Week 40 en Week 52
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Dag 1, Week 4, Week 10, Week 28, Week 40 en Week 52
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Tijd tot eerste matige of ernstige COPD-exacerbatie
Tijdsspanne: Behandelingsperiode van 52 weken
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Behandelingsperiode van 52 weken
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Tijd tot de eerste ernstige COPD-exacerbatie
Tijdsspanne: Behandelingsperiode van 52 weken
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Behandelingsperiode van 52 weken
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Respons op de Saint George's Respiratory Questionnaire (SGRQ) (een afname ten opzichte van baseline in totale score ≥4) bij aangewezen kliniekbezoeken
Tijdsspanne: Week 4, week 10, week 28, week 40 en week 52
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Week 4, week 10, week 28, week 40 en week 52
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Verandering ten opzichte van baseline in de SGRQ-totaalscore en domeinscores bij elk aangewezen kliniekbezoek
Tijdsspanne: Week 4, week 10, week 28, week 40 en week 52
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Week 4, week 10, week 28, week 40 en week 52
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Verandering ten opzichte van de uitgangswaarde in de geforceerde vitale capaciteit (FVC) vóór de dosis 's ochtends bij aangewezen kliniekbezoeken
Tijdsspanne: Week 4, week 10, week 28, week 40 en week 52
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Week 4, week 10, week 28, week 40 en week 52
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Verander van pre-dosis naar 2 uur post-dosis ochtend-FVC bij aangewezen kliniekbezoeken
Tijdsspanne: Dag 1, Week 4, Week 10, Week 28, Week 40 en Week 52
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Dag 1, Week 4, Week 10, Week 28, Week 40 en Week 52
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CAT-respons (afname ten opzichte van baseline ≥2 punten) bij aangewezen kliniekbezoeken
Tijdsspanne: Week 4, week 10, week 28, week 40 en week 52
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Week 4, week 10, week 28, week 40 en week 52
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Verandering ten opzichte van baseline in gezondheidsgerelateerde kwaliteit van leven (afname ten opzichte van baseline in totale SGRQ-score ≥4) gedurende 52 weken behandeling.
Tijdsspanne: Behandelingsperiode van 52 weken
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Behandelingsperiode van 52 weken
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Rate of moderate and severe COPD exacerbations over 52 weeks of treatment
Tijdsspanne: 52-week treatment period
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Annualized rate of moderate and severe COPD exacerbations as observed during the 52-week study treatment period. |
52-week treatment period
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Rate of severe COPD exacerbations over 52 weeks of treatment
Tijdsspanne: 52-week treatment period
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Annualized rate of severe COPD exacerbations as observed during 52-week treatment period |
52-week treatment period
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Change from baseline to each inter-visit period in the percentage of days without intake of rescue medication
Tijdsspanne: Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52
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Change from baseline (defined as the 2-week run-in period prior to randomization) to each inter-visit period (defined as the period of time between designated clinic visits) in percentage of days without rescue medication |
Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52
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Change from baseline to each inter-visit period in the average use of rescue medication (number of puffs/day)
Tijdsspanne: Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52
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Change from baseline (defined as the 2-week run-in period prior to randomization) in the average number of puffs per day of rescue medication for each inter-visit period (defined as the period of time between designated clinic visits). |
Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52
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Change from baseline in 2-hour post-dose morning FVC at designated clinic visits
Tijdsspanne: Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52
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Change from baseline (defined as the pre-dose value on Day 1) in 2-hour post-dose morning FVC at designated clinic visits |
Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52
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Change from baseline to each inter-visit period in the average E-RS total score and domain scores
Tijdsspanne: Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52
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Change from baseline (defined as the 2-week run-in period prior to randomization) in the average E-RS total score and E-RS domain scores for the period of time between designated clinic visits. |
Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52
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Change from baseline in COPD Assessment Test (CAT) score at designated clinic visit
Tijdsspanne: Week 4, Week 10, Week 28, Week 40, & Week 52
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The CAT is composed of 8 questions to measure the impact of COPD on daily life, which are scored from 0 to 5 with higher scores reflecting greater impact. |
Week 4, Week 10, Week 28, Week 40, & Week 52
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Modified Medical Research Council (mMRC) dyspnea scale at designated clinic visits
Tijdsspanne: Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52
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Descriptive statistics of the mMRC dyspnea scale score at designated clinic visits. The mMRC dyspnea scale is graded from 0 to 4, with higher grades reflecting greater severity. |
Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Thomas Siler, MD, Midwest Chest Consultants
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
- Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.
- Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
- Ferenci P, Lockwood A, Mullen K, Tarter R, Weissenborn K, Blei AT. Hepatic encephalopathy--definition, nomenclature, diagnosis, and quantification: final report of the working party at the 11th World Congresses of Gastroenterology, Vienna, 1998. Hepatology. 2002 Mar;35(3):716-21. doi: 10.1053/jhep.2002.31250.
- Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
- Anthonisen NR, Manfreda J, Warren CP, Hershfield ES, Harding GK, Nelson NA. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 1987 Feb;106(2):196-204. doi: 10.7326/0003-4819-106-2-196.
- Bajaj JS, Cordoba J, Mullen KD, Amodio P, Shawcross DL, Butterworth RF, Morgan MY; International Society for Hepatic Encephalopathy and Nitrogen Metabolism (ISHEN). Review article: the design of clinical trials in hepatic encephalopathy--an International Society for Hepatic Encephalopathy and Nitrogen Metabolism (ISHEN) consensus statement. Aliment Pharmacol Ther. 2011 Apr;33(7):739-47. doi: 10.1111/j.1365-2036.2011.04590.x. Epub 2011 Feb 9.
- Lopez AD, Shibuya K, Rao C, Mathers CD, Hansell AL, Held LS, Schmid V, Buist S. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J. 2006 Feb;27(2):397-412. doi: 10.1183/09031936.06.00025805. No abstract available.
- Montes de Oca M, Perez-Padilla R, Talamo C, Halbert RJ, Moreno D, Lopez MV, Muino A, Jose Roberto BJ, Valdivia G, Pertuze J, Ana Maria BM; PLATINO Team. Acute bronchodilator responsiveness in subjects with and without airflow obstruction in five Latin American cities: the PLATINO study. Pulm Pharmacol Ther. 2010 Feb;23(1):29-35. doi: 10.1016/j.pupt.2009.09.005. Epub 2009 Oct 8.
- Lane DC, Stemkowski S, Stanford RH, Tao Z. Initiation of Triple Therapy with Multiple Inhalers in Chronic Obstructive Pulmonary Disease: An Analysis of Treatment Patterns from a U.S. Retrospective Database Study. J Manag Care Spec Pharm. 2018 Nov;24(11):1165-1172. doi: 10.18553/jmcp.2018.24.11.1165.
- Lipson DA, Barnhart F, Brealey N, Brooks J, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Martinez FJ, Singh D, Tabberer M, Wise RA, Pascoe SJ; IMPACT Investigators. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. N Engl J Med. 2018 May 3;378(18):1671-1680. doi: 10.1056/NEJMoa1713901. Epub 2018 Apr 18.
- Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, Kessler R. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Oct 15;180(8):741-50. doi: 10.1164/rccm.200904-0492OC. Epub 2009 Jul 30.
- Hanania NA, Crater GD, Morris AN, Emmett AH, O'Dell DM, Niewoehner DE. Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD. Respir Med. 2012 Jan;106(1):91-101. doi: 10.1016/j.rmed.2011.09.002. Epub 2011 Oct 29.
- Jung KS, Park HY, Park SY, Kim SK, Kim YK, Shim JJ, Moon HS, Lee KH, Yoo JH, Lee SD; Korean Academy of Tuberculosis and Respiratory Diseases study group; Korea Chronic Obstructive Pulmonary Disease study group. Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: a randomized controlled study. Respir Med. 2012 Mar;106(3):382-9. doi: 10.1016/j.rmed.2011.09.004. Epub 2011 Oct 4.
- Lipson DA, Barnacle H, Birk R, Brealey N, Locantore N, Lomas DA, Ludwig-Sengpiel A, Mohindra R, Tabberer M, Zhu CQ, Pascoe SJ. FULFIL Trial: Once-Daily Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Aug 15;196(4):438-446. doi: 10.1164/rccm.201703-0449OC.
- Singh D, Papi A, Corradi M, Pavlisova I, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Vestbo J. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting beta2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet. 2016 Sep 3;388(10048):963-73. doi: 10.1016/S0140-6736(16)31354-X. Epub 2016 Sep 1.
- Vestbo J, Papi A, Corradi M, Blazhko V, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Singh D. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. Lancet. 2017 May 13;389(10082):1919-1929. doi: 10.1016/S0140-6736(17)30188-5. Epub 2017 Apr 3.
- Jones PW, Tabberer M, Chen WH. Creating scenarios of the impact of COPD and their relationship to COPD Assessment Test (CAT) scores. BMC Pulm Med. 2011 Aug 11;11:42. doi: 10.1186/1471-2466-11-42.
- Mullerova H, Dransfield MT, Thomashow B, Jones PW, Rennard S, Karlsson N, Fageras M, Metzdorf N, Petruzzelli S, Rommes J, Sciurba FC, Tabberer M, Merrill D, Tal-Singer R. Clinical Development and Research Applications of the Chronic Obstructive Pulmonary Disease Assessment Test. Am J Respir Crit Care Med. 2020 May 1;201(9):1058-1067. doi: 10.1164/rccm.201907-1369PP. No abstract available.
- Kon SS, Canavan JL, Jones SE, Nolan CM, Clark AL, Dickson MJ, Haselden BM, Polkey MI, Man WD. Minimum clinically important difference for the COPD Assessment Test: a prospective analysis. Lancet Respir Med. 2014 Mar;2(3):195-203. doi: 10.1016/S2213-2600(14)70001-3. Epub 2014 Feb 4.
- Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten C, Gustafsson P, Jensen R, Macintyre N, McKay RT, Pedersen OF, Pellegrino R, Viegi G, Wanger J. Standardisation of lung function testing: the authors' replies to readers' comments. Eur Respir J. 2010 Dec;36(6):1496-8. doi: 10.1183/09031936.00130010. No abstract available.
- Seemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 May;157(5 Pt 1):1418-22. doi: 10.1164/ajrccm.157.5.9709032.
- Jones PW. St. George's Respiratory Questionnaire: MCID. COPD. 2005 Mar;2(1):75-9. doi: 10.1081/copd-200050513.
- Jones P, Lareau S, Mahler DA. Measuring the effects of COPD on the patient. Respir Med. 2005 Dec;99 Suppl B:S11-8. doi: 10.1016/j.rmed.2005.09.011. Epub 2005 Oct 19.
- Jones PW, Gelhorn H, Wilson H, Karlsson N, Menjoge S, Mullerova H, Rennard SI, Tal-Singer R, Merrill D, Tabberer M. Responder Analyses for Treatment Effects in COPD Using the St George's Respiratory Questionnaire. Chronic Obstr Pulm Dis. 2017 Mar 2;4(2):124-131. doi: 10.15326/jcopdf.4.2.2017.0130.
- Roland NJ, Bhalla RK, Earis J. The local side effects of inhaled corticosteroids: current understanding and review of the literature. Chest. 2004 Jul;126(1):213-9. doi: 10.1378/chest.126.1.213.
- Ellepola AN, Samaranayake LP. Inhalational and topical steroids, and oral candidosis: a mini review. Oral Dis. 2001 Jul;7(4):211-6.
- Roger JH, Bratton DJ, Mayer B, Abellan JJ, Keene ON. Treatment policy estimands for recurrent event data using data collected after cessation of randomised treatment. Pharm Stat. 2019 Jan;18(1):85-95. doi: 10.1002/pst.1910. Epub 2018 Nov 8.
- Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Barker-Collo S, Bartels DH, Bell ML, Benjamin EJ, Bennett D, Bhalla K, Bikbov B, Bin Abdulhak A, Birbeck G, Blyth F, Bolliger I, Boufous S, Bucello C, Burch M, Burney P, Carapetis J, Chen H, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahodwala N, De Leo D, Degenhardt L, Delossantos A, Denenberg J, Des Jarlais DC, Dharmaratne SD, Dorsey ER, Driscoll T, Duber H, Ebel B, Erwin PJ, Espindola P, Ezzati M, Feigin V, Flaxman AD, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabriel SE, Gakidou E, Gaspari F, Gillum RF, Gonzalez-Medina D, Halasa YA, Haring D, Harrison JE, Havmoeller R, Hay RJ, Hoen B, Hotez PJ, Hoy D, Jacobsen KH, James SL, Jasrasaria R, Jayaraman S, Johns N, Karthikeyan G, Kassebaum N, Keren A, Khoo JP, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lipnick M, Lipshultz SE, Ohno SL, Mabweijano J, MacIntyre MF, Mallinger L, March L, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGrath J, Mensah GA, Merriman TR, Michaud C, Miller M, Miller TR, Mock C, Mocumbi AO, Mokdad AA, Moran A, Mulholland K, Nair MN, Naldi L, Narayan KM, Nasseri K, Norman P, O'Donnell M, Omer SB, Ortblad K, Osborne R, Ozgediz D, Pahari B, Pandian JD, Rivero AP, Padilla RP, Perez-Ruiz F, Perico N, Phillips D, Pierce K, Pope CA 3rd, Porrini E, Pourmalek F, Raju M, Ranganathan D, Rehm JT, Rein DB, Remuzzi G, Rivara FP, Roberts T, De Leon FR, Rosenfeld LC, Rushton L, Sacco RL, Salomon JA, Sampson U, Sanman E, Schwebel DC, Segui-Gomez M, Shepard DS, Singh D, Singleton J, Sliwa K, Smith E, Steer A, Taylor JA, Thomas B, Tleyjeh IM, Towbin JA, Truelsen T, Undurraga EA, Venketasubramanian N, Vijayakumar L, Vos T, Wagner GR, Wang M, Wang W, Watt K, Weinstock MA, Weintraub R, Wilkinson JD, Woolf AD, Wulf S, Yeh PH, Yip P, Zabetian A, Zheng ZJ, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2095-128. doi: 10.1016/S0140-6736(12)61728-0.
- Ferguson GT, Rabe KF, Martinez FJ, Fabbri LM, Wang C, Ichinose M, Bourne E, Ballal S, Darken P, DeAngelis K, Aurivillius M, Dorinsky P, Reisner C. Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial. Lancet Respir Med. 2018 Oct;6(10):747-758. doi: 10.1016/S2213-2600(18)30327-8. Epub 2018 Sep 16.
- Papi A, Vestbo J, Fabbri L, Corradi M, Prunier H, Cohuet G, Guasconi A, Montagna I, Vezzoli S, Petruzzelli S, Scuri M, Roche N, Singh D. Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial. Lancet. 2018 Mar 17;391(10125):1076-1084. doi: 10.1016/S0140-6736(18)30206-X. Epub 2018 Feb 9.
- Wedzicha JA, Singh D, Vestbo J, Paggiaro PL, Jones PW, Bonnet-Gonod F, Cohuet G, Corradi M, Vezzoli S, Petruzzelli S, Agusti A; FORWARD Investigators. Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations. Respir Med. 2014 Aug;108(8):1153-62. doi: 10.1016/j.rmed.2014.05.013. Epub 2014 Jun 6.
Nuttige links
- <p>Global Initiative for Chronic Obstructive Lung Disease: Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2020 Report)</p>
- <p>ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials</p>
- <p>COPD Assessment Test (CAT)</p>
- <p>Measuring shortness of breath (dyspnea) in COPD.</p>
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
27 april 2022
Primaire voltooiing (Werkelijk)
12 januari 2026
Studie voltooiing (Werkelijk)
12 januari 2026
Studieregistratiedata
Eerst ingediend
23 maart 2020
Eerst ingediend dat voldeed aan de QC-criteria
23 maart 2020
Eerst geplaatst (Werkelijk)
25 maart 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
21 september 2026
Laatste update ingediend die voldeed aan QC-criteria
17 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Chronische ziekte
- Ziekte attributen
- Ziekten van de luchtwegen
- Longziekten
- Longziekten, obstructief
- Pathologische aandoeningen, tekenen en symptomen
- Longziekte, chronisch obstructief
- Organische chemicaliën
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Polycyclische verbindingen
- Amines
- Zwangerschap
- Zwangere
- Steroïden
- Verbindingen met gefuseerde ring
- Alcohol
- Zwangerschap
- Aminoalcoholen
- Ethanolamines
- Quaternaire ammoniumverbindingen
- Oniumverbindingen
- Pyrrolidines
- Steroïden, gechloreerd
- Formoterolfumaraat
- Beclomethason
- Glycopyrrolaat
Andere studie-ID-nummers
- CLI-05993AA3-06
- 2020-002389-16 (EudraCT-nummer)
- 2023 (Subsidie/contract van de Amerikaanse NIH)
- 2023-510172-31-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
IPD-toegangscriteria voor delen
Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .