Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2019-03-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Bromide Administered Via Dry Powder Inhaler in COPD

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Male and female adults (40 ≤ age ≤ 85 years) with a diagnosis of COPD;

• Current smokers or ex-smokers;

• A Post-bronchodilator FEV1 ≥30% and <80% of the predicted normal value and FEV1/FVC (Forced Vital Capacity) < 0.7;

• Patients' COPD therapy (stable regimen at least 30 days before screening) with either:

• Inhaled corticosteroids/long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination

• Inhaled corticosteroids/long-acting β2-agonist (free or fixed) combination

• Inhaled long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination

• Inhaled long-acting muscarinic antagonist alone.

Exclusion Criteria:

• Pregnant and lactating women;

• Diagnosis of asthma;

• Known respiratory disorders other than COPD;

• Patients treated for a moderate or severe COPD exacerbation within 6 weeks prior to screening or during the run-in period;

• Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia;

• Patients who have clinically significant cardiovascular condition;