Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)

• Status: Completed
• Trial end date: 2020-05-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the superiority of CHF 5993 pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) over Symbicort® Turbuhaler® in terms of pulmonary function, as well as to assess its safety.

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

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Bromides; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; 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 ratio < 0.7 at least 10-15 minutes after 4 puffs (4 x 100 µg) of salbutamol pMDI

• At least one exacerbation in the 12 months preceding the screening visit

Exclusion Criteria:

• Pregnant or lactating women

• Diagnosis of asthma, history of allergic rhinitis or atopy

• Patients treated for exacerbations in the 4 weeks prior to screening visit

• Patients treated with non-cardioselective ß-blockers in the month preceding the 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 Pro Re Nata

• 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