Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease

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

Summary

The purpose of this study is to determine the triple combination of beclometasone dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of severe COPD patients (chronic obstructive pulmonary disease)

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

Details

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

Criteria

Inclusion Criteria:

• Male and female COPD patients aged ≥ 40 years

• Current smokers or ex-smokers

• FEV1<50% predicted (FEV1/FVC <0,7)

• at least 1 documented exacerbations in the last 12 Mo

Exclusion Criteria:

• Pregnant or lactating women and all women physiologically capable of becoming pregnant

• Diagnosis of asthma, history of allergic rhinitis or atopy

• Patients treated for exacerbations 1 Mo prior to screening

• Patients treated with non-cardioselective β-blockers

• Patients treated with long-acting antihistamines

• Known respiratory disorders other than COPD

• Patients who have clinically significant cardiovascular condition