Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD (NCT01917331) | Clinical Trial Compass
CompletedPhase 3
Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD
Hungary1,368 participantsStarted 2014-03-21
Plain-language summary
Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of beclometasone + formoterol + glycopyrrolate (BDP/FF/GB) administered via pressurised metered dose inhaler (pMDI) over the equivalent dose of Foster® (beclometasone dipropionate (BDP) / formoterol fumarate (FF), in patients diagnosed with chronic obstructive pulmonary disease (COPD) after 52 weeks of treatment.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female adults aged ≥ 40 years with a diagnosis of COPD
* Current smokers or ex-smokers
* A post-bronchodilator Forced Expiratory Volume in the 1st Second (FEV1) \< 50% of the predicted normal value and a post- bronchodilator FEV1/ Forced Vital Capacity (FVC) \< 0.7
* At least one exacerbation in the 12 months preceding the screening visit
Exclusion Criteria:
* Pregnant or lactating women
* Diagnosis of asthma or history of allergic rhinitis or atopy
* Patients treated with non-cardioselective β-blockers in the month preceding the screening visit
* Patients treated for exacerbations in the 4 weeks prior to screening visit
* Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN
* Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
* Known respiratory disorders other than COPD
* Patients who have clinically significant cardiovascular condition
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1_Change From Baseline in Pre-dose Morning Forced Expiratory Volume in the 1st Second (FEV1) -- at Week 26
Timeframe: Baseline (Week 0), Week 26.
2
2_Change From Baseline in 2-hour Post-dose FEV1 -- at Week 26
Timeframe: Baseline (Week 0) to 2-hour post-dose at Week 26.
3
3_Transition Dyspnoea Index (TDI) Focal Score -- at Week 26