Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD

第3相 完了 NCT01917331

概要

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.

1_Change From Baseline in Pre-dose Morning Forced Expiratory Volume in the 1st Second (FEV1) -- at Week 26

Baseline (Week 0), Week 26. · litre

2_Change From Baseline in 2-hour Post-dose FEV1 -- at Week 26

Baseline (Week 0) to 2-hour post-dose at Week 26. · litre

3_Transition Dyspnoea Index (TDI) Focal Score -- at Week 26

Baseline (Week 0), Week 26. · score on a scale

BENITIONS で見る ClinicalTrials.gov の原文を見る

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すべての治験