A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Pleven, Bulgarien, 5800
- Novartis Investigative Site
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Plovdiv, Bulgarien, 4002
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Ruse, Bulgarien, 7002
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Sofia, Bulgarien, 1431
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Varna, Bulgarien, 9010
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HUS, Finland, 00029
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Helsinki, Finland, 00029
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Pori, Finland, FIN-28500
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Turku, Finland, 20521
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Alabama
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Vestavia, Alabama, Forenede Stater, 35216
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California
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Huntington Beach, California, Forenede Stater, 92647
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Lakewood, California, Forenede Stater, 90712-151
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Los Angeles, California, Forenede Stater, 90048
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Orange, California, Forenede Stater, 92868
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Stockton, California, Forenede Stater, 95207
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Walnut Creek, California, Forenede Stater, 94598
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Colorado
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Boulder, Colorado, Forenede Stater, 80304
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96814
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Illinois
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Lombard, Illinois, Forenede Stater, 60148
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O'Fallon, Illinois, Forenede Stater, 62269
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Peoria, Illinois, Forenede Stater, 61602
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Indiana
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Evansville, Indiana, Forenede Stater, 47712
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Iowa
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Ames, Iowa, Forenede Stater, 50010
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Iowa City, Iowa, Forenede Stater, 52240
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Waterloo, Iowa, Forenede Stater, 50702
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Kentucky
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Bowling Green, Kentucky, Forenede Stater, 42101
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70115
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Slidell, Louisiana, Forenede Stater, 70458
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Maine
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Bangor, Maine, Forenede Stater, 04401
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Maryland
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Baltimore, Maryland, Forenede Stater, 21224
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Michigan
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Livonia, Michigan, Forenede Stater, 48152
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55407
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39209
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Picayune, Mississippi, Forenede Stater, 39466
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Missouri
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St. Charles, Missouri, Forenede Stater, 63301
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Montana
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Missoula, Montana, Forenede Stater, 59804
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68506
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Omaha, Nebraska, Forenede Stater, 68131
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Nevada
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Henderson, Nevada, Forenede Stater, 89014
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Las Vegas, Nevada, Forenede Stater, 89119
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New York
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Rochester, New York, Forenede Stater, 14618
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Ohio
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Dayton, Ohio, Forenede Stater, 45459
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Dublin, Ohio, Forenede Stater, 43016
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73112
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Oklahoma City, Oklahoma, Forenede Stater, 73103
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Oregon
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Eugene, Oregon, Forenede Stater, 97404
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Medford, Oregon, Forenede Stater, 97504-8741
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South Carolina
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Spartanburg, South Carolina, Forenede Stater, 29303
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37912
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Texas
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Corsicana, Texas, Forenede Stater, 75110
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Ft. Worth, Texas, Forenede Stater, 76104
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Lufkin, Texas, Forenede Stater, 75904
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McKinney, Texas, Forenede Stater, 75069
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Virginia
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Abingdon, Virginia, Forenede Stater, 24210
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Midlothian, Virginia, Forenede Stater, 23114
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Newport News, Virginia, Forenede Stater, 23606
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Barceloneta, Puerto Rico, 00617
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San Juan, Puerto Rico, 00909
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San Juan, Puerto Rico, 00918
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Brasov, Rumænien, 500281
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Bucharest, Rumænien, 060011
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Bucuresti, Rumænien, 50554
- Novartis Investigative Site
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Cluj-Napoca, Rumænien, 400371
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District 1
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Bucharest, District 1, Rumænien, 10457
- Novartis Investigative Site
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Bucharest, District 1, Rumænien, 11475
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District 3
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Bucharest, District 3, Rumænien, 030303
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Bucharest, District 3, Rumænien, 030317
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Jud. Constanta
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Constanta, Jud. Constanta, Rumænien, 900002
- Novartis Investigative Site
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Jud. Iasi
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Iasi, Jud. Iasi, Rumænien, 700115
- Novartis Investigative Site
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Andalucia
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Granada, Andalucia, Spanien, 18014
- Novartis Investigative Site
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Málaga, Andalucia, Spanien, 29010
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Cataluña
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Badalona, Cataluña, Spanien, 08914
- Novartis Investigative Site
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Barcelona, Cataluña, Spanien
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Canet de Mar, Cataluña, Spanien, 08360
- Novartis Investigative Site
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Centelles, Cataluña, Spanien, 08540
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Tarragona, Cataluña, Spanien, 43350
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Comunidad Valenciana
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Valencia, Comunidad Valenciana, Spanien, 46015
- Novartis Investigative Site
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Budapest, Ungarn, 1125
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Budapest, Ungarn, 1046
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Gyor, Ungarn, 9024
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Mako, Ungarn, 6900
- Novartis Investigative Site
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Nyiregyhaza, Ungarn, 4400
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Pecs, Ungarn, 7635
- Novartis Investigative Site
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Szazhalombatta, Ungarn, 2440
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Szolnok, Ungarn, H-5000
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Torokbalint, Ungarn, 2045
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Male and female adults aged ≥40 years
- Patients with stable COPD according to GOLD strategy (GOLD 2011).
- Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- Patients with an mMRC ≥ grade 2
Exclusion Criteria:
- History of long QT syndrome or prolonged QTc
- Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
- Patients with Type I or uncontrolled Type II diabetes
- Patients with a history of asthma or have concomitant pulmonary disease
- Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible
- Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety
- Other protocol defined inclusion/exclusion criteria may apply
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Eksperimentel: QVA149 dose 1
QVA149 27.5/12.5 μg capsules
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QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
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Eksperimentel: QVA149 dose 2
QVA149 27.5/25 μg capsules
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QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
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Aktiv komparator: QAB149
QAB149 75 μg capsules
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QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI
To mimic QAB149
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Tidsramme: 56 weeks
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The overall rate of adverse events reported from initiation through 30 days post last dose.
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56 weeks
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Time to Premature Discontinuation of Treatment
Tidsramme: 56 weeks
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methodTime to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve.
The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment earl
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56 weeks
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Change From Baseline in Pre-dose Trough FEV1
Tidsramme: Day 29, 57,, 85, 141, 197, 253, 309 and 365
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Pulmonary function assessments were performed using centralized spirometry according to international standards.
Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1.
A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.
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Day 29, 57,, 85, 141, 197, 253, 309 and 365
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Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Tidsramme: Day 1, 29, 57, 85, 141, 197, 253, 309, and 365
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Pulmonary function assessments were performed using centralized spirometry according to international standards.
Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1.
A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.
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Day 1, 29, 57, 85, 141, 197, 253, 309, and 365
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Change From Baseline in FVC Measurement at All Post-baseline Time Points
Tidsramme: Day1, 29, 57, 85, 141, 197, 253, 309, and 365
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Pulmonary function assessments were performed using centralized spirometry according to international standards.
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Day1, 29, 57, 85, 141, 197, 253, 309, and 365
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Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation
Tidsramme: 52 weeks
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Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)
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52 weeks
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Change From Baseline in Mean Total Daily Symptom Scores
Tidsramme: 52 weeks
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The participant recorded symptom scores twice daily in the eDiary.
The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening.
The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom.
The maximum daytime total score is 27 and the maximum nighttime total score is 27.
The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day.
The maximum possible total daily score is 54.
A negative change from baseline indicated improvement.
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52 weeks
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Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period
Tidsramme: 52 weeks
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Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.
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52 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CQVA149A2340
- 2012-001998-93
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