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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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 pMDI over the equivalent dose of Foster® in COPD (Chronic Obstructive Pulmonary Disease) patients after 52 weeks of treatment

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Formoterol Fumarate; Glycopyrrolate

Criteria

Inclusion Criteria:

• Male or female adults aged ≥ 40 years with a diagnosis of COPD

• Current smokers or ex-smokers

• A post-bronchodilator FEV1 < 50% of the predicted normal value and a post- bronchodilator FEV1/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