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En studie hos pasienter med kronisk obstruktiv lungesykdom (FUTURE)

24. juni 2026 oppdatert av: Chiesi Farmaceutici S.p.A.

En 12-ukers, multisenter, multinasjonal, randomisert, dobbeltblind, dobbeltdummy, 2-arms parallell gruppestudie som sammenligner effektiviteten og sikkerheten til Foster® 100/6 (beklometasondipropionat 100 µg pluss formoterol 6 µg/aktivering), 2 Puffs b.i.d., Versus Seretide® 500/50 (Fluticasone 500 µg Plus Salmeterol 50 µg/Actuation), 1 Inhalation b.i.d., hos pasienter med kronisk obstruktiv lungesykdom

Hensikten med denne studien er å bestemme effekten på helsestatus og spirometriske verdier av Foster® 100/6 (to drag b.i.d.) versus Seretide® 500/50 (én inhalasjon b.i.d.), over en 12-ukers behandlingsperiode i kronisk obstruktiv behandling. Pasienter med lungesykdom (KOLS).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Kronisk obstruktiv lungesykdom (KOLS) er en uhelbredelig, svekkende og progressiv sykdom som kan være dødelig. Den nylige Global Burden of Disease-studien rangerer KOLS som den 6. ledende årsaken til dødelighet og den 12. ledende årsaken til sykelighet over hele verden. Videre indikerer trender i bruken av medisinske ressurser at de økonomiske kostnadene ved KOLS fortsetter å stige i direkte forhold til den aldrende befolkningen, økningen i forekomst av sykdom og kostnadene ved nye og eksisterende medisinske og folkehelseintervensjoner.

Studietype

Intervensjonell

Registrering (Faktiske)

419

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Danmark
      • Aarhus, Danmark
        • Aarhus University Hospital
      • Copenhagen, Danmark
        • Bispebjerg Hospital
      • Copenhagen, Danmark
        • Dept. of Cardiology and Respiratory Medicine
      • Gentofte Municipality, Danmark
        • Gentofte Hospital
      • Odense, Danmark
        • Odense University Hospital
  • Frankrike
      • Toulon, Frankrike
        • Centre Hospitalier
  • Italia
      • Bologna, Italia
        • Ospedale Sant'Orsola-Malpighi
      • Catania, Italia
        • A.O. Policlinico
      • Monza, Italia
        • A.O. S. Gerardo
      • Naples, Italia
        • Azienda Ospedaliera Monaldi
      • Pisa, Italia
        • Universita di Pisa
      • Roma, Italia
        • IRCCS San Raffaele La Pisana
      • Rome, Italia, 00161
        • Policlinico Umberto I - VIII Padiglione
  • Polen
      • Gdansk, Polen
        • NZOZ "Non Nocere"
      • Koszalin, Polen
        • Niepubliczny Zakład Opieki Zdrowotnej "PROFILAKTYKA"
      • Krakow, Polen
        • Szpital Uniwersytecki w Krakowie
      • Krakow, Polen
        • Szpital Specjalistyczny im Jana Pawła II
      • Lodz, Polen
        • Prywatny Gabinet Specjalistyczny
      • Szczecin, Polen
        • Samodzielny Publiczny Szpital Kliniczny
      • Warsaw, Polen
        • Chorób Płuc
      • Warsaw, Polen
        • Gabinet Lekarski SERIA IWONA GRZELEWSKA-RZYMOWSKA
      • Warsaw, Polen
        • Instytut Gruźlicy i Chorób Płuc. Zakład Diagnostyki i Leczenia Niewydolności Oddychania
      • Warsaw, Polen
        • Zakład Fizjopatologii Oddychania, Instytut Gruźlicy i Chorób Płuc
      • Wroclaw, Polen
        • DOBROSTAN - Gabinety Lekarskie
      • Wroclaw, Polen
        • NZOZ Lekarze Specjaliści J.Małolepszy i Partnerzy
      • Zgierz, Polen
        • Wojewódzki Szpital Specjalistyczny im. M. Curie-Skłodowskiej)
  • Slovakia
      • Humenné, Slovakia
        • Neštátna ambulancia pneumológie a ftizeológie, Nemocničná
      • Nové Zámky, Slovakia
        • Diunea, sro. Ambulancia PaF
      • Ostrov, Slovakia
        • ALERGOIMUNO s.r.o
      • Poprad, Slovakia
        • Pľúcna ambulancia, Poliklinika ADUS
      • Prešov, Slovakia
        • PULMO, s.r.o
      • Prievidza, Slovakia
        • PNEUMO-MED, s.r.o
      • Spišská Nová Ves, Slovakia
        • Pľúcna ambulancia, Hrebenár s.r.o
      • Trnava, Slovakia
        • PNEUMO-CENTRUM, s.r.o, Poliklinika
  • Spania
      • Barcelona, Spania
        • Hospital Del Mar
      • Sabadell, Spania
        • Hospital Parc Tauli
      • Vic, Spania
        • Hospital General Vic
  • Storbritannia
      • Belfast, Storbritannia
        • Belfast City Hospital
      • London, Storbritannia
        • Kings College Hospital
      • Newcastle, Storbritannia
        • Freeman Hospital
  • Tyrkia (Türkiye)
      • Adana, Tyrkia (Türkiye)
        • Çukurova Üniversitesi
      • Antalya, Tyrkia (Türkiye)
        • Akdeniz Universitesi
      • Antalya, Tyrkia (Türkiye)
        • Bilim Üniversitesi
      • Bornova, Tyrkia (Türkiye)
        • Ege Üniversitesi
      • Bursa, Tyrkia (Türkiye)
        • Uludağ Üniversitesi
      • Gaziantep, Tyrkia (Türkiye)
        • Gaziantep Üniversitesi
      • Istanbul, Tyrkia (Türkiye)
        • Fatih Üniversitesi
      • Istanbul, Tyrkia (Türkiye)
        • Marmara Üniversitesi
      • Izmir, Tyrkia (Türkiye)
        • Dokuz Eylul Universitesi
      • Kayseri, Tyrkia (Türkiye)
        • Erciyes Üniversitesi
  • Tyskland
      • Berlin, Tyskland
        • Praxis Dr. Jorg Kampschulte
      • Leipzig, Tyskland
        • Praxis Dr. Jörg Winkler
      • Lübeck, Tyskland
        • KLB Healthresearch
      • Lübeck, Tyskland
        • KLD Helthreseach
      • Magdeburg, Tyskland
        • SMO.MD GmbH Zentrum für Klinische Studien
      • Saarbrücken, Tyskland
        • Pneumologische Gemeinschaftspraxis Saarbrücken
      • Wedel, Tyskland
        • Fachinternistische Gemeinschafts
      • Wiesloch, Tyskland
        • Pneumologische Praxis Dr Redlich
      • Wuppertal, Tyskland
        • Gemeinschaftspraxis für Pneumologie
  • Ungarn
      • Balassagyarmat, Ungarn
        • Dr. Kenessey Albert Kórház - Rendelőintézet
      • Budapest, Ungarn
        • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház
      • Békés, Ungarn
        • Békés Megyei Képviselő-testület Pándy Kálmán Kórház
      • Debrecen, Ungarn
        • Centrum-Tüdőgyógyászati Klinika
      • Kecskemét, Ungarn
        • Bács-Kiskun Megeyi Önkormanyzat...
      • Mosonmagyaróvár, Ungarn
        • Karolina Kórház és Rendelőintézet Tüdőgyógyászat
      • Nyíregyháza, Ungarn
        • Jósa András Hospital
      • Nyíregyháza, Ungarn
        • Békés Megyei Képviselő-testület Pándy Kálmán Kórház
      • Szigetszentmiklös, Ungarn
        • Chiesi Clinical Centre Szigetszentmiklös

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  1. Mannlige eller kvinnelige pasienter i alderen ≥ 40 år, som har signert et informert samtykkeskjema før oppstart av en studierelatert prosedyre eller etter gjeldende skriftlig informert samtykke innhentet av juridisk representant.

  2. Polikliniske pasienter med diagnosen KOLS og inkludert:

    1. Røykehistorie på minst 10 pakkeår definert som [(antall sigaretter røykt per dag) x (antall år med røyking) / 20], både nåværende og tidligere røykere er kvalifisert.
    2. Bruk av bronkodilatatorer de siste 2 månedene for å besøke 1.
    3. Post-bronkodilator FEV1 < 60 % av forventet normalverdi.
    4. Post-bronkodilator FEV1/FVC < 0,7.
    5. En ≥ 5 % respons på en reversibilitetstest.
    6. En baseline Dyspné Index (BDI) fokalscore mindre eller lik 10 (skal også oppfylles ved besøk 2).
  3. Anamnese med ikke mer enn én KOLS-forverring de siste 12 månedene (uten å ta hensyn til de siste 2 månedene) for å besøke 1.
  4. En samarbeidende holdning og evne til å bli opplært til riktig bruk av pMDI og DPI (Accuhaler®, sirkulær støpt plastinhalator) inhalatorer.

Hovedekskluderingskriterier:

  1. Klinisk relevante luftveislidelser.
  2. Gjeldende diagnose av astma eller andre luftveislidelser enn KOLS.
  3. Klinisk signifikante laboratorie- og EKG-avvik som indikerer en signifikant eller ustabil samtidig sykdom som kan påvirke gjennomførbarheten av resultatene av studien i henhold til etterforskerens vurdering.
  4. Pasienter med KOLS-eksacerbasjon i de 2 månedene før screening og i løpet av studieperioden.
  5. Pasienter som trenger langvarig (minst 12 timer daglig) oksygenbehandling for kronisk hypoksemi.
  6. Pasienter behandlet med depotkortikosteroider i de 2 månedene før besøk 1 og under innkjøringsperioden.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Foster®
Participants received 2 puffs of Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose) administered via a pMDI twice daily (BID), resulting in a total daily dose of beclomethasone dipropionate 400 μg plus formoterol 24 μg, for a duration of 12 weeks. To ensure blinding, participants received one inhalation of placebo matching Seretide® Accuhaler® via a inhaler BID, for a duration of 12 weeks.
Legemiddel: Beclomethasone Dipropionate - Formoterol
Administered via a pressurized metered-dose inhaler
Andre navn:
  • Foster
Aktiv komparator: Seretide® Accuhaler®
Participants received one inhalation of Seretide® Accuhaler® (fluticasone 500 μg plus salmeterol 50 μg/actuation) administered via inhaler, BID resulting in a total daily dose of fluticasone 1000 μg plus salmeterol 100 μg, for a duration of 12 weeks. To ensure blinding, participants receieved two puffs of placebo matching Foster® via pMDI, BID for a duration of 12 weeks.
Legemiddel: Fluticasone - Salmeterol
Administered via a pressurized metered-dose inhaler
Andre navn:
  • Seretide Accuhaler®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Area Under the Curve (AUC) 0-30min Standardized by Time of Change From Pre-dose in Forced Expiratory Volume in One Second (FEV1) in the Morning of Day 1
Tidsramme: on Day 1 (V2)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessment were implemented at pre-dose, and 5, 15 and 30 minutes post inhalation
on Day 1 (V2)
Transition Dyspnoea Index (TDI) Score at Day 84
Tidsramme: Day 84 (V5)

TDI has three domains as follows:

  1. Functional impairment, which determines the impact of breathlessness on the ability to carry out activities;
  2. Magnitude of task, which determines the type of task that causes breathlessness;
  3. Magnitude of effort, which establishes the level of effort that results in breathlessness

The TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain. The sum of all domains yields the TDI focal score of -9 (major deterioration) to +9 (major improvement).

Adjusted means were reported.
Day 84 (V5)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84
Tidsramme: on Day 84 (V5)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessments were implemented pre-dose, 5, 15 and 30 minutes post inhalation.
on Day 84 (V5)
AUC 0-30min Standardized by Time of Change From Baseline in FEV1 After Drug Inhalation in the Morning of Day 84
Tidsramme: on Day 84 (V5)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessments were implemented at baseline and 5,15 and 30 minutes post inhalation.
on Day 84 (V5)
Change From Baseline (CFB) in Pre-dose Morning FEV1
Tidsramme: Weeks 4, 8 and 12
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.
Weeks 4, 8 and 12
Change From Baseline in Pre-dose Morning Forced Vital Capacity (FVC)
Tidsramme: Weeks 4, 8 and 12
FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits. Higher values indicate improved lung capacity and reduced airway obstruction. Adjusted means were reported.
Weeks 4, 8 and 12
Change From Pre-dose in Morning FEV1 at 5, 15 and 30 Min After Drug Intake
Tidsramme: 5, 15, 30 Min post inhalation at Weeks 0 (V2) and 12 (Day 84, V5)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.
5, 15, 30 Min post inhalation at Weeks 0 (V2) and 12 (Day 84, V5)
Change From Baseline in Morning FEV1 at 5, 15 and 30 Min After Drug Intake
Tidsramme: at 5, 15 and 30 mins post inhalation at Week 12 (Day 84, V5)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.
at 5, 15 and 30 mins post inhalation at Week 12 (Day 84, V5)
Change From Pre-dose in Morning FVC at 5, 15 and 30 Min After Drug Intake
Tidsramme: at 5, 15 and 30 min post inhalation Week 0 (V2) & Week 12 Day 84, (V5)
FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits. Higher values indicate improved lung capacity and reduced airway obstruction. Adjusted means were reported.
at 5, 15 and 30 min post inhalation Week 0 (V2) & Week 12 Day 84, (V5)
Change From Baseline to Each Two-Week Period in COPD Symptom Scores
Tidsramme: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

COPD symptom scores consists of following 6 items recorded by the participants in diary.

  • the ability to perform the usual daily activities;
  • breathlessness over the previous 24h;
  • waking at night due to respiratory symptoms;
  • breathlessness on rising;
  • cough over the previous 24h;
  • sputum production over the previous 24h.

Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst). Baseline COPD symptom score has been calculated as the mean of the COPD symptom scores recorded in the run-in period. Each item or total scores were averaged over each 2 week period. Average COPD symptom score in each two-week period has been calculated as the mean of the item or total score recorded in each two-week period. Adjusted means were reported.
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Change From Baseline to Each Two-Week Period in Percentage of COPD Symptom-Free Days
Tidsramme: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

COPD symptom scores consists of following 6 items recorded by the participants in diary.

  • ability to perform the usual daily activities;
  • breathlessness over the previous 24h;
  • waking at night due to respiratory symptoms;
  • breathlessness on rising;
  • cough over the previous 24h;
  • sputum production over the previous 24h.

Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst).

A COPD symptom-free day is a day with total COPD symptom scores = 0. Baseline % of COPD symptom-free days is calculated as the % ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)*100.

Reported values (in form of adjusted means) reflect a percentage (%).

% of COPD symptom-free days in each two-week period is calculated as % (ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)*100.
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Change From Baseline to Entire Treatment Period in Percentage of COPD Symptom-Free Days
Tidsramme: Baseline, Weeks 1 through 12

COPD symptom scores consists of following 6 items recorded by the participants in diary.

  • ability to perform the usual daily activities;
  • breathlessness over the previous 24h;
  • waking at night due to respiratory symptoms;
  • breathlessness on rising;
  • cough over the previous 24h;
  • sputum production over the previous 24h.

Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst).

A COPD symptom-free day is a day with total COPD symptom scores = 0. Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of COPD symptom-free days is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)*100.

% of COPD symptom-free days in each two-week period is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)*100.
Baseline, Weeks 1 through 12
Change From Baseline to Each Two-Week Period in Average Use of Rescue Salbutamol Consumption
Tidsramme: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Number of rescue salbutamol puffs per day were recorded in the diary. Baseline use of rescue medication has been calculated as the mean number of puffs per day in the run-in period. Average use of rescue medication in each two-week period has been calculated as the mean number of puffs per day in each two week period. Adjusted means were reported.
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Change From Baseline to Each Two-Week Period in Percentage of Rescue Salbutamol-Free Days
Tidsramme: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

A rescue medication-free day is a day with number of puffs of rescue medication = 0.

Reported values (in form of adjusted means) reflect a percentage (%). Baseline percentage (%) of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)*100.

% of rescue medication-free days in each two-week period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the two-week period)*100.
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Change From Baseline to Entire Treatment Period in Percentage of Rescue Salbutamol-Free Days
Tidsramme: at week 12 (V5)

A rescue medication-free day is a day with number of puffs of rescue medication = 0.

Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)*100.

% of rescue medication-free days in the entire treatment period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the entire treatment period)*100.
at week 12 (V5)
Change From Baseline in the St George's Respiratory Questionnaire (SGRQ) Component and Total Scores
Tidsramme: at Week 12 (V5)

SGRQ is a 76-item questionnaire developed to measure health in chronic airflow limitation and designed to be self-completed by the participant. It consists of 76-items across three domains:

  • Symptoms, which evaluates the frequency and severity of respiratory issues like coughing, sputum production, and breathlessness;
  • Activity, which measures limitations in physical activities due to breathlessness;
  • Impacts, which examines psychological and social effects, including feelings of stigma, loss of control, and daily life disruption.

Each domain score ranges from 0 to 100 with higher scores indicating the worst health status. Total score was obtained by combining the weighted scores from each domain and ranging from 0 (better health) to 100 (Worst health).
at Week 12 (V5)
Change From Baseline in Pre-dose and in Post-dose Distance Walked (6 Minute Walking Test - 6MWT)
Tidsramme: Week 12 (V5), pre-dose and post-dose
The 6MWT was carried out following standardized procedures, according to ATS guidelines. The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test. Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes. The patients sit at rest for at least 10 minutes before the test start. The longer distance covered, the better the outcome.
Week 12 (V5), pre-dose and post-dose
Change From Pre-dose in Post-dose Distance Walked (6MWT)
Tidsramme: on Week 0 (Day 1, V2) and Week 12 (V5, Day 84)
The 6MWT was carried out following standardized procedures, according to ATS guidelines. The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test. Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes. The patients sit at rest for at least 10 minutes before the test start.
on Week 0 (Day 1, V2) and Week 12 (V5, Day 84)
Number of Participants With COPD Exacerbations From Week 0 Through Week 12
Tidsramme: Week 12
A COPD exacerbation is defined as "a sustained worsening of the participants condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and requires unscheduled medical intervention [leading to prescriptions of systemic corticosteroids (at least 3 days)] and/or antibiotics (at least 5 days), or need for a visit to an emergency department or hospitalization) in a participant with underlying COPD".
Week 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tidsramme: From first dose of study drug until end of the treatment (up to 84 days)

AE=An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine.

Serious AE= An adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect.

ADR=A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility Serious ADR=An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect.

Severe AE= "Severe" refers to the intensity of an AE; the event itself may be of relatively minor medical significance but intense.
From first dose of study drug until end of the treatment (up to 84 days)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chiesi Farmaceutici S.p.A.

Etterforskere

  • Hovedetterforsker: Dave Singh, MD, The Medicine Evaluation Unit - Manchester, UK
  • Hovedetterforsker: Jorgen Vestbo, MD, Dept. of Cardiology and Respiratory Medicine - Copenhagen, Denmark

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. april 2011

Primær fullføring (Faktiske)

13. mars 2012

Studiet fullført (Faktiske)

13. mars 2012

Datoer for studieregistrering

Først innsendt

19. november 2010

Først innsendt som oppfylte QC-kriteriene

19. november 2010

Først lagt ut (Antatt)

22. november 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CCD-0910-PR-0021
  • 2009-014410-10 (EudraCT-nummer)

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