Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Eine Studie an Patienten mit chronisch obstruktiver Lungenerkrankung (FUTURE)

24. Juni 2026 aktualisiert von: Chiesi Farmaceutici S.p.A.

Eine 12-wöchige, multizentrische, multinationale, randomisierte, doppelblinde Doppel-Dummy-Studie mit zweiarmiger Parallelgruppe zum Vergleich der Wirksamkeit und Sicherheit von Foster® 100/6 (Beclomethasondipropionat 100 µg plus Formoterol 6 µg/Aktion), 2 Puffs b.i.d., versus Seretide® 500/50 (Fluticason 500 µg plus Salmeterol 50 µg/Sprühstoß), 1 Inhalation b.i.d., bei Patienten mit chronisch obstruktiver Lungenerkrankung

Der Zweck der vorliegenden Studie besteht darin, die Auswirkungen auf den Gesundheitszustand und die spirometrischen Werte von Foster® 100/6 (zwei Sprühstöße b.i.d.) im Vergleich zu Seretide® 500/50 (eine Inhalation b.i.d.) über einen 12-wöchigen Behandlungszeitraum bei chronisch obstruktiver Erkrankung zu bestimmen Patienten mit Lungenerkrankungen (COPD).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Die chronisch obstruktive Lungenerkrankung (COPD) ist eine unheilbare, schwächende und fortschreitende Krankheit, die tödlich sein kann. Die jüngste Global Burden of Disease Study stuft COPD als sechsthäufigste Todesursache und zwölfthäufigste Morbiditätsursache weltweit ein. Darüber hinaus deuten Trends bei der Nutzung medizinischer Versorgungsressourcen darauf hin, dass die wirtschaftlichen Kosten von COPD in direktem Zusammenhang mit der alternden Bevölkerung, der Zunahme der Krankheitsprävalenz und den Kosten neuer und bestehender medizinischer und öffentlicher Gesundheitsinterventionen weiter steigen.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

419

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Deutschland
      • Berlin, Deutschland
        • Praxis Dr. Jorg Kampschulte
      • Leipzig, Deutschland
        • Praxis Dr. Jörg Winkler
      • Lübeck, Deutschland
        • KLB Healthresearch
      • Lübeck, Deutschland
        • KLD Helthreseach
      • Magdeburg, Deutschland
        • SMO.MD GmbH Zentrum für Klinische Studien
      • Saarbrücken, Deutschland
        • Pneumologische Gemeinschaftspraxis Saarbrücken
      • Wedel, Deutschland
        • Fachinternistische Gemeinschafts
      • Wiesloch, Deutschland
        • Pneumologische Praxis Dr Redlich
      • Wuppertal, Deutschland
        • Gemeinschaftspraxis für Pneumologie
  • Dänemark
      • Aarhus, Dänemark
        • Aarhus University Hospital
      • Copenhagen, Dänemark
        • Bispebjerg Hospital
      • Copenhagen, Dänemark
        • Dept. of Cardiology and Respiratory Medicine
      • Gentofte Municipality, Dänemark
        • Gentofte Hospital
      • Odense, Dänemark
        • Odense University Hospital
  • Frankreich
      • Toulon, Frankreich
        • Centre Hospitalier
  • Italien
      • Bologna, Italien
        • Ospedale Sant'Orsola-Malpighi
      • Catania, Italien
        • A.O. Policlinico
      • Monza, Italien
        • A.O. S. Gerardo
      • Naples, Italien
        • Azienda Ospedaliera Monaldi
      • Pisa, Italien
        • Universita di Pisa
      • Roma, Italien
        • IRCCS San Raffaele La Pisana
      • Rome, Italien, 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)
  • Slowakei
      • Humenné, Slowakei
        • Neštátna ambulancia pneumológie a ftizeológie, Nemocničná
      • Nové Zámky, Slowakei
        • Diunea, sro. Ambulancia PaF
      • Ostrov, Slowakei
        • ALERGOIMUNO s.r.o
      • Poprad, Slowakei
        • Pľúcna ambulancia, Poliklinika ADUS
      • Prešov, Slowakei
        • PULMO, s.r.o
      • Prievidza, Slowakei
        • PNEUMO-MED, s.r.o
      • Spišská Nová Ves, Slowakei
        • Pľúcna ambulancia, Hrebenár s.r.o
      • Trnava, Slowakei
        • PNEUMO-CENTRUM, s.r.o, Poliklinika
  • Spanien
      • Barcelona, Spanien
        • Hospital Del Mar
      • Sabadell, Spanien
        • Hospital Parc Tauli
      • Vic, Spanien
        • Hospital General Vic
  • Türkei (türkiye)
      • Adana, Türkei (türkiye)
        • Çukurova Üniversitesi
      • Antalya, Türkei (türkiye)
        • Akdeniz Universitesi
      • Antalya, Türkei (türkiye)
        • Bilim Üniversitesi
      • Bornova, Türkei (türkiye)
        • Ege Üniversitesi
      • Bursa, Türkei (türkiye)
        • Uludağ Üniversitesi
      • Gaziantep, Türkei (türkiye)
        • Gaziantep Üniversitesi
      • Istanbul, Türkei (türkiye)
        • Fatih Üniversitesi
      • Istanbul, Türkei (türkiye)
        • Marmara Üniversitesi
      • Izmir, Türkei (türkiye)
        • Dokuz Eylul Universitesi
      • Kayseri, Türkei (türkiye)
        • Erciyes Üniversitesi
  • 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
  • Vereinigtes Königreich
      • Belfast, Vereinigtes Königreich
        • Belfast City Hospital
      • London, Vereinigtes Königreich
        • Kings College Hospital
      • Newcastle, Vereinigtes Königreich
        • Freeman Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

40 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  1. Männliche oder weibliche Patienten im Alter von ≥ 40 Jahren, die vor Beginn eines studienbezogenen Verfahrens eine Einverständniserklärung oder gegebenenfalls eine vom gesetzlichen Vertreter eingeholte schriftliche Einverständniserklärung unterzeichnet haben.

  2. Ambulante Patienten mit COPD-Diagnose und einschließlich:

    1. Rauchergeschichte von mindestens 10 Packungsjahren, definiert als [(Anzahl der pro Tag gerauchten Zigaretten) x (Anzahl der Jahre des Rauchens) / 20], sowohl aktuelle als auch ehemalige Raucher sind teilnahmeberechtigt.
    2. Verwendung von Bronchodilatatoren in den letzten 2 Monaten bis zum Besuch 1.
    3. FEV1 nach Bronchodilatation < 60 % des vorhergesagten Normalwerts.
    4. FEV1/FVC nach Bronchodilatation < 0,7.
    5. Eine Reaktion von ≥ 5 % auf einen Reversibilitätstest.
    6. Ein Baseline Dyspnoea Index (BDI) Focal Score kleiner oder gleich 10 (muss auch bei Visite 2 erreicht werden).
  3. Vorgeschichte von nicht mehr als einer COPD-Exazerbation in den letzten 12 Monaten (ohne Berücksichtigung der letzten 2 Monate) zu Besuch 1.
  4. Eine kooperative Einstellung und Fähigkeit, in der richtigen Verwendung von pMDI- und DPI-Inhalatoren (Accuhaler®, kreisförmig geformter Kunststoffinhalator) geschult zu werden.

Hauptausschlusskriterien:

  1. Klinisch relevante Atemwegserkrankungen.
  2. Aktuelle Diagnose von Asthma oder anderen Atemwegserkrankungen als COPD.
  3. Klinisch signifikante Labor- und EKG-Anomalien, die auf eine signifikante oder instabile Begleiterkrankung hinweisen, die sich nach Einschätzung des Prüfers auf die Realisierbarkeit der Studienergebnisse auswirken können.
  4. Patienten mit COPD-Exazerbation in den 2 Monaten vor dem Screening und während des Studienzeitraums.
  5. Patienten, die eine Langzeit-Sauerstofftherapie (mindestens 12 Stunden täglich) wegen chronischer Hypoxämie benötigen.
  6. Patienten, die in den 2 Monaten vor Visite 1 und während der Einlaufphase mit Depotkortikosteroiden behandelt wurden.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: Beclomethasone Dipropionate - Formoterol
Administered via a pressurized metered-dose inhaler
Andere Namen:
  • Fördern
Aktiver 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.
Arzneimittel: Fluticasone - Salmeterol
Administered via a pressurized metered-dose inhaler
Andere Namen:
  • Seretide Accuhaler®

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Chiesi Farmaceutici S.p.A.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

12. April 2011

Primärer Abschluss (Tatsächlich)

13. März 2012

Studienabschluss (Tatsächlich)

13. März 2012

Studienanmeldedaten

Zuerst eingereicht

19. November 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. November 2010

Zuerst gepostet (Geschätzt)

22. November 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren