Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Een studie bij patiënten met chronische obstructieve longziekte (FUTURE)

24 juni 2026 bijgewerkt door: Chiesi Farmaceutici S.p.A.

Een 12 weken durende, multicentrische, multinationale, gerandomiseerde, dubbelblinde, dubbeldummy, 2-armige parallelle groepsstudie waarin de werkzaamheid en veiligheid van Foster® 100/6 (Beclomethasondipropionaat 100 µg plus formoterol 6 µg/verstuiving) wordt vergeleken, 2 Puffs tweemaal daags, versus Seretide® 500/50 (fluticason 500 µg plus salmeterol 50 µg/verstuiving), 1 inhalatie tweemaal daags, bij patiënten met chronische obstructieve longziekte

Het doel van de huidige studie is het bepalen van de effecten op de gezondheidsstatus en spirometrische waarden van Foster® 100/6 (twee pufjes tweemaal daags) versus Seretide® 500/50 (één inhalatie tweemaal daags), gedurende een behandelingsperiode van 12 weken bij chronische obstructieve Longziekte (COPD) patiënten.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Chronische obstructieve longziekte (COPD) is een ongeneeslijke, slopende en progressieve ziekte die fataal kan zijn. De recente Global Burden of Disease Study rangschikt COPD als de 6e belangrijkste doodsoorzaak en de 12e belangrijkste oorzaak van morbiditeit wereldwijd. Bovendien wijzen trends in het gebruik van medische zorgmiddelen erop dat de economische kosten van COPD blijven stijgen in direct verband met de vergrijzing van de bevolking, de toename van de prevalentie van ziekten en de kosten van nieuwe en bestaande medische en volksgezondheidsinterventies.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

419

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Denemarken
      • Aarhus, Denemarken
        • Aarhus University Hospital
      • Copenhagen, Denemarken
        • Bispebjerg Hospital
      • Copenhagen, Denemarken
        • Dept. of Cardiology and Respiratory Medicine
      • Gentofte Municipality, Denemarken
        • Gentofte Hospital
      • Odense, Denemarken
        • Odense University Hospital
  • Duitsland
      • Berlin, Duitsland
        • Praxis Dr. Jorg Kampschulte
      • Leipzig, Duitsland
        • Praxis Dr. Jörg Winkler
      • Lübeck, Duitsland
        • KLB Healthresearch
      • Lübeck, Duitsland
        • KLD Helthreseach
      • Magdeburg, Duitsland
        • SMO.MD GmbH Zentrum für Klinische Studien
      • Saarbrücken, Duitsland
        • Pneumologische Gemeinschaftspraxis Saarbrücken
      • Wedel, Duitsland
        • Fachinternistische Gemeinschafts
      • Wiesloch, Duitsland
        • Pneumologische Praxis Dr Redlich
      • Wuppertal, Duitsland
        • Gemeinschaftspraxis für Pneumologie
  • Frankrijk
      • Toulon, Frankrijk
        • Centre Hospitalier
  • Hongarije
      • Balassagyarmat, Hongarije
        • Dr. Kenessey Albert Kórház - Rendelőintézet
      • Budapest, Hongarije
        • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház
      • Békés, Hongarije
        • Békés Megyei Képviselő-testület Pándy Kálmán Kórház
      • Debrecen, Hongarije
        • Centrum-Tüdőgyógyászati Klinika
      • Kecskemét, Hongarije
        • Bács-Kiskun Megeyi Önkormanyzat...
      • Mosonmagyaróvár, Hongarije
        • Karolina Kórház és Rendelőintézet Tüdőgyógyászat
      • Nyíregyháza, Hongarije
        • Jósa András Hospital
      • Nyíregyháza, Hongarije
        • Békés Megyei Képviselő-testület Pándy Kálmán Kórház
      • Szigetszentmiklös, Hongarije
        • Chiesi Clinical Centre Szigetszentmiklös
  • Italië
      • Bologna, Italië
        • Ospedale Sant'Orsola-Malpighi
      • Catania, Italië
        • A.O. Policlinico
      • Monza, Italië
        • A.O. S. Gerardo
      • Naples, Italië
        • Azienda Ospedaliera Monaldi
      • Pisa, Italië
        • Universita di Pisa
      • Roma, Italië
        • IRCCS San Raffaele La Pisana
      • Rome, Italië, 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)
  • Slowakije
      • Humenné, Slowakije
        • Neštátna ambulancia pneumológie a ftizeológie, Nemocničná
      • Nové Zámky, Slowakije
        • Diunea, sro. Ambulancia PaF
      • Ostrov, Slowakije
        • ALERGOIMUNO s.r.o
      • Poprad, Slowakije
        • Pľúcna ambulancia, Poliklinika ADUS
      • Prešov, Slowakije
        • PULMO, s.r.o
      • Prievidza, Slowakije
        • PNEUMO-MED, s.r.o
      • Spišská Nová Ves, Slowakije
        • Pľúcna ambulancia, Hrebenár s.r.o
      • Trnava, Slowakije
        • PNEUMO-CENTRUM, s.r.o, Poliklinika
  • Spanje
      • Barcelona, Spanje
        • Hospital Del Mar
      • Sabadell, Spanje
        • Hospital Parc Tauli
      • Vic, Spanje
        • Hospital General Vic
  • Turkije (Türkiye)
      • Adana, Turkije (Türkiye)
        • Çukurova Üniversitesi
      • Antalya, Turkije (Türkiye)
        • Akdeniz Universitesi
      • Antalya, Turkije (Türkiye)
        • Bilim Üniversitesi
      • Bornova, Turkije (Türkiye)
        • Ege Üniversitesi
      • Bursa, Turkije (Türkiye)
        • Uludağ Üniversitesi
      • Gaziantep, Turkije (Türkiye)
        • Gaziantep Üniversitesi
      • Istanbul, Turkije (Türkiye)
        • Fatih Üniversitesi
      • Istanbul, Turkije (Türkiye)
        • Marmara Üniversitesi
      • Izmir, Turkije (Türkiye)
        • Dokuz Eylul Universitesi
      • Kayseri, Turkije (Türkiye)
        • Erciyes Üniversitesi
  • Verenigd Koninkrijk
      • Belfast, Verenigd Koninkrijk
        • Belfast City Hospital
      • London, Verenigd Koninkrijk
        • Kings College Hospital
      • Newcastle, Verenigd Koninkrijk
        • Freeman Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusiecriteria:

  1. Mannelijke of vrouwelijke patiënten van ≥ 40 jaar die een formulier voor geïnformeerde toestemming hebben ondertekend voorafgaand aan de start van een studiegerelateerde procedure of, zodra van toepassing, schriftelijke geïnformeerde toestemming verkregen door wettelijke vertegenwoordiger.

  2. Ambulante patiënten met de diagnose COPD en inclusief:

    1. Rookgeschiedenis van ten minste 10 pakjaren gedefinieerd als [(aantal gerookte sigaretten per dag) x (aantal jaren roken) / 20], zowel huidige als ex-rokers komen in aanmerking.
    2. Gebruik van luchtwegverwijders in de afgelopen 2 maanden voor bezoek 1.
    3. Post-bronchusverwijdende FEV1 < 60% van de voorspelde normale waarde.
    4. Post-bronchodilatator FEV1/FVC < 0,7.
    5. Een respons van ≥ 5% op een reversibiliteitstest.
    6. Een Baseline Dyspnoea Index (BDI) focale score van minder dan of gelijk aan 10 (ook te behalen bij bezoek 2).
  3. Geschiedenis van niet meer dan één COPD-exacerbatie in de afgelopen 12 maanden (zonder rekening te houden met de laatste 2 maanden) om te bezoeken 1.
  4. Een coöperatieve houding en het vermogen om te worden getraind in het juiste gebruik van pMDI- en DPI-inhalatoren (Accuhaler®, circulaire gegoten plastic inhalator).

Belangrijkste uitsluitingscriteria:

  1. Klinisch relevante luchtwegaandoeningen.
  2. Huidige diagnose van astma of andere ademhalingsstoornissen dan COPD.
  3. Klinisch significante laboratorium- en ECG-afwijkingen die duiden op een significante of onstabiele bijkomende ziekte die de haalbaarheid van de resultaten van het onderzoek kan beïnvloeden volgens het oordeel van de onderzoeker.
  4. Patiënten met COPD-exacerbatie in de 2 maanden voorafgaand aan de screening en tijdens de onderzoeksperiode.
  5. Patiënten die langdurig (minstens 12 uur per dag) zuurstoftherapie nodig hebben voor chronische hypoxemie.
  6. Patiënten behandeld met depotcorticosteroïden in de 2 maanden voorafgaand aan het bezoek 1 en tijdens de inloopperiode.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Beclomethasone Dipropionate - Formoterol
Administered via a pressurized metered-dose inhaler
Andere namen:
  • Voeden
Actieve vergelijker: 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.
Geneesmiddel: Fluticasone - Salmeterol
Administered via a pressurized metered-dose inhaler
Andere namen:
  • Seretide Accuhaler®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chiesi Farmaceutici S.p.A.

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 april 2011

Primaire voltooiing (Werkelijk)

13 maart 2012

Studie voltooiing (Werkelijk)

13 maart 2012

Studieregistratiedata

Eerst ingediend

19 november 2010

Eerst ingediend dat voldeed aan de QC-criteria

19 november 2010

Eerst geplaatst (Geschat)

22 november 2010

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

24 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren