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Une étude chez des patients atteints de maladie pulmonaire obstructive chronique (FUTURE)

24 juin 2026 mis à jour par: Chiesi Farmaceutici S.p.A.

Une étude de 12 semaines, multicentrique, multinationale, randomisée, en double aveugle, double factice, en groupes parallèles à 2 bras comparant l'efficacité et l'innocuité de Foster® 100/6 (dipropionate de béclométhasone 100 µg plus formotérol 6 µg/activation), 2 Bouffées b.i.d., Versus Seretide® 500/50 (Fluticasone 500 µg Plus Salmétérol 50 µg/Actuation), 1 Inhalation b.i.d., chez les patients atteints de maladie pulmonaire obstructive chronique

Le but de la présente étude est de déterminer les effets sur l'état de santé et les valeurs spirométriques de Foster® 100/6 (deux bouffées b.i.d.) par rapport à Seretide® 500/50 (une inhalation b.i.d.), sur une période de traitement de 12 semaines dans la maladie obstructive chronique. Patients atteints de maladie pulmonaire (MPOC).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

La maladie pulmonaire obstructive chronique (MPOC) est une maladie incurable, débilitante et évolutive qui peut être mortelle. La récente étude Global Burden of Disease Study classe la MPOC au 6ème rang des causes de mortalité et au 12ème rang des causes de morbidité dans le monde. En outre, les tendances dans l'utilisation des ressources de soins médicaux indiquent que le coût économique de la MPOC continue d'augmenter en relation directe avec le vieillissement de la population, l'augmentation de la prévalence de la maladie et le coût des interventions médicales et de santé publique nouvelles et existantes.

Type d'étude

Interventionnel

Inscription (Réel)

419

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

La description

Critère d'intégration:

  1. Patients de sexe masculin ou féminin âgés de ≥ 40 ans, qui ont signé un formulaire de consentement éclairé avant le début de toute procédure liée à l'étude ou, une fois applicable, un consentement éclairé écrit obtenu par le représentant légal.

  2. Patients ambulatoires avec un diagnostic de BPCO et comprenant :

    1. Antécédents de tabagisme d'au moins 10 paquets-années définis comme [(nombre de cigarettes fumées par jour) x (nombre d'années de tabagisme) / 20], les fumeurs actuels et les anciens fumeurs sont éligibles.
    2. Utilisation de bronchodilatateurs au cours des 2 mois précédents pour visiter 1.
    3. VEMS post-bronchodilatateur < 60 % de la valeur normale prédite.
    4. VEMS/CVF post-bronchodilatateur < 0,7.
    5. Une réponse ≥ 5% à un test de réversibilité.
    6. Un score focal de l'indice de base de la dyspnée (BDI) inférieur ou égal à 10 (à respecter également à la visite 2).
  3. Antécédents de pas plus d'une exacerbation de BPCO au cours des 12 derniers mois (sans tenir compte des 2 derniers mois) à visiter 1.
  4. Une attitude coopérative et une capacité à être formé à l'utilisation appropriée des inhalateurs pMDI et DPI (Accuhaler®, inhalateur circulaire en plastique moulé).

Principaux critères d'exclusion :

  1. Troubles respiratoires cliniquement pertinents.
  2. Diagnostic actuel d'asthme ou de troubles respiratoires autres que la MPOC.
  3. Anomalies de laboratoire et d'ECG cliniquement significatives indiquant une maladie concomitante significative ou instable pouvant avoir un impact sur la faisabilité des résultats de l'étude selon le jugement de l'investigateur.
  4. Patients présentant une exacerbation de la MPOC dans les 2 mois précédant le dépistage et pendant la période d'étude.
  5. Patients nécessitant une oxygénothérapie à long terme (au moins 12 heures par jour) pour une hypoxémie chronique.
  6. Patients traités par corticoïdes retard dans les 2 mois précédant la visite 1 et pendant la période de rodage.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Beclomethasone Dipropionate - Formoterol
Administered via a pressurized metered-dose inhaler
Autres noms:
  • Favoriser
Comparateur actif: 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.
Médicament: Fluticasone - Salmeterol
Administered via a pressurized metered-dose inhaler
Autres noms:
  • Seretide Accuhaler®

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Chiesi Farmaceutici S.p.A.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 avril 2011

Achèvement primaire (Réel)

13 mars 2012

Achèvement de l'étude (Réel)

13 mars 2012

Dates d'inscription aux études

Première soumission

19 novembre 2010

Première soumission répondant aux critères de contrôle qualité

19 novembre 2010

Première publication (Estimé)

22 novembre 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 juin 2026

Dernière vérification

1 juin 2026

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Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

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