Trial | NCT03590379  Report issue

Title

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)
A Phase II, Multicentre, Randomised, Double-blind, Double-dummy, Active-controlled, 3-way Cross-over Study to Evaluate the Efficacy of CHF 5993 Administered Via Dry Powder Inhaler (DPI) Versus CHF 5993 Via Pressurized Metered Dose Inhaler (pMDI) and CHF 1535 pMDI in Patients With Chronic Obstructive Pulmonary Disease

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    366
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
Study Started
Jun 15
2018
Primary Completion
Oct 16
2018
Study Completion
Mar 06
2019
Last Update
Apr 12
2021

Drug CHF 5993 DPI [budesonide (rhinocort), formoterol (foradil)]

BDP/FF/GB DPI

Drug CHF5993 pMDI [budesonide (rhinocort), formoterol (foradil)]

BDP/FF/GB pMDI

Drug CHF 1535 pMDI

BDP/FF pMDI

Drug Placebo DPI

CHF 5993 DPI matched placebo

Drug Placebo pMDI

CHF 5993 pMDI matched Placebo (direct blinding of active CHF 5993 and CHF 1535 pMDIs)

CHF 5993 DPI Experimental

BDP/FF/GB DPI 100/6/12,5 mcg

CHF 5993 pMDI Active Comparator

BDP/FF/GB pMDI 100/6/12,5 mcg

CHF 1535 pMDI Active Comparator

BDP/FF pMDI 100/6 mcg

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;
No Results Posted