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

Study Overview
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Brief Summary
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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.

Official Title
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A 24-week, Double Blind, Double Dummy, Randomized, Multinational, Multicentre, 2-arm Parallel Group,Active Controlled Clinical Trial of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide Administered Via pMDI (CHF 5993) Versus the Fixed Combination of Budesonide Plus Formoterol Fumarate (Symbicort® Turbuhaler®) in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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COPD (Chronic Obstructive Pulmonary Disease)

Intervention / Treatment
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* Drug: CHF 5993 100/6/12.5 µg
* Drug: 160 µg budesonide + 4.5 µg formoterol fumarate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF 5993 100/6/12.5 µg<br>Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose (BDP/FF/GB) (Beclometasone dipropionate / Formoterol Fumarate / glycoppyronium Bromide) | Drug: CHF 5993 100/6/12.5 µg<br>* Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose<br>|
| Active Comparator: Symbicort Turbuhaler 160/4.5 µg<br>Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (160µg + 4.5 µg expresses the delivered dose; 200 µg + 6 µg expresses the metered dose) ( BUD/FF) (Budesonide/Formoterol Fumarate) | Drug: 160 µg budesonide + 4.5 µg formoterol fumarate<br>* Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24 | Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24 | Baseline to Week 24 | 
| Change from Baseline in 2-hour post-dose FEV1 at week 24 | Change from Baseline in 2-hour post-dose FEV1 at week 24 | Baseline to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at week 24 | Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose | Baseline to Week 24 | 
| Time to First COPD exacerbation | Time to First COPD exacerbation | Baseline to week 24 | 
| Rate of COPD exacerbations | Rate of COPD exacerbations | Baseline to week 24 | 
| Change in COPD Assessment Test (CAT) | Change in COPD Assessment Test (CAT) | At all visits (from baseline to Week 24) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Anticholinergics, Triple Combination