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)

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: CHF 5993 DPI
* Drug: CHF5993 pMDI
* Drug: CHF 1535 pMDI
* Drug: Placebo DPI
* Drug: Placebo pMDI


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF 5993 DPI<br>BDP/FF/GB DPI 100/6/12,5 mcg | Drug: CHF 5993 DPI<br>* BDP/FF/GB DPI<br>Drug: Placebo pMDI<br>* CHF 5993 pMDI matched Placebo (direct blinding of active CHF 5993 and CHF 1535 pMDIs)<br>|
| Active Comparator: CHF 5993 pMDI<br>BDP/FF/GB pMDI 100/6/12,5 mcg | Drug: CHF5993 pMDI<br>* BDP/FF/GB pMDI<br>Drug: Placebo DPI<br>* CHF 5993 DPI matched placebo<br>|
| Active Comparator: CHF 1535 pMDI<br>BDP/FF pMDI 100/6 mcg | Drug: CHF 1535 pMDI<br>* BDP/FF pMDI<br>Drug: Placebo DPI<br>* CHF 5993 DPI matched placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 AUC0-12h (Area Under the Curve for Forced Expiratory Volume in 1 second measured serially for 0-12 hours) normalised by time (L) on dosing Day 28 | To demonstrate the non-inferiority between CHF 5993 DPI and CHF 5993 pMDI in terms of FEV1 AUC0-12h normalized by time, in COPD patients | Day 28 | 
| Trough FEV1 at 24 hours (L) on dosing Day 28. | To demonstrate the non-inferiority between CHF 5993 DPI and CHF 5993 pMDI in terms of trough FEV1 at 24h on dosing Day 28 in COPD patients | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pre-dose morning FEV1 (L) on Day 28 | To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures. | from Baseline to Day 28 | 
| Change from baseline in FEV1 AUC0-4h normalised by time (L) on Day 28 | To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures. | from Baseline to Day 28 | 
| Change from baseline in FEV1 AUC0-12h normalised by time (L) on Day 1 | To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures. | from Baseline to Day 1 |