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

Phase 3 Completed NCT01917331

Condition	Chronic Obstructive Pulmonary Disease
Phase	Phase 3
Sponsor	Chiesi Farmaceutici S.p.A.
Status	Completed
Enrollment	1,368 participants
Interventions	Beclometasone/Formoterol/Glycopyrrolate, Beclometasone/Formoterol
Start date	Mar 21, 2014
Completion date	Jan 14, 2016
Results posted	Jun 3, 2026

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.

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

CHF 5993 pMDI	0.082 litre
CHF 1535 pMDI Foster®	0.001 litre

p-value	< 0.001
Adjusted mean difference	0.081 (95% CI 0.052–0.109)

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

CHF 5993 pMDI	0.261 litre
CHF 1535 pMDI Foster®	0.145 litre

p-value	< 0.001
Adjusted mean difference	0.117 (95% CI 0.086–0.147)

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

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

CHF 5993 pMDI	1.71 score on a scale
CHF 1535 pMDI Foster®	1.50 score on a scale

p-value	= 0.160
Adjusted mean difference	0.21 (95% CI -0.08–0.51)

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and — University of Tennessee Graduate School of Medicine
Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®T — Chiesi Farmaceutici S.p.A.
Tiotropium/Salmeterol Inhalation Powder in COPD — Boehringer Ingelheim
Risk Factors, Costs, and Impacts of ED Boarding — University of Maryland, Baltimore
Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructiv — United Therapeutics
Anti-Platelets in Chronic Obstructive Pulmonary Disease — Brigham and Women's Hospital

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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