Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD

Study Overview
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Brief Summary
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Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of Beclometasone+Formoterol+Glycopyrrolate (BDP/FF/GB) administered via pMDI over the equivalent dose of Foster® in COPD (Chronic Obstructive Pulmonary Disease) patients after 52 weeks of treatment

Detailed Description
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This 52-week randomised 2 parallel groups study aimed at evaluating the superiority of fixed triple therapy with ICS/LABA/LAMA compared to ICS/LABA in severe to very severe COPD patients. Patients' eligibility was checked during the screening visit including the review of medical history, spirometry assessments, routine labs, physical examination, 12-lead ECG, vital signs measurement. This visit was followed by a 2-week open-label run-in period under Foster® (BDP/FF 400/24 µg total daily dose). Eligible patients were then randomised to either fixed triple therapy BDP/FF/GB or BDP/FF. During the 52-week treatment period, completing patients did have 5 subsequent visits post randomisation scheduled respectively after 4 (Visit 3), 12 (Visit 4), 26 (Visit 5), 40 (Visit 6) and 52 (Visit 7) weeks of treatment. During these, pre-dose and post-dose spirometry, 12-lead ECG, vital signs, dyspnea assessments were performed. Rescue medication use, compliance with the treatment and EXACT-PRO questionnaire were recorded daily (via an electronic diary) during the run-in and randomised treatment periods.

Official Title
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A Phase 3 Randomised Double Blind Randomised Parallel Multinational Trial Comparing a Fixed Combination of Beclometasone+Formoterol+Glycopyrrolate to Foster® in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Beclometasone/Formoterol/Glycopyrrolate
* Drug: Beclometasone/Formoterol


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 < 0.7 At least one exacerbation in the 12 months preceding the screening visit Exclusion Criteria: Pregnant or lactating women Diagnosis of asthma or history of allergic rhinitis or atopy Patients treated with non-cardioselective β-blockers in the month preceding the screening visit Patients treated for exacerbations in the 4 weeks prior to 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 PRN 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: Beclometasone/Formoterol/Glycopyrrolate<br>CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations bid | Drug: Beclometasone/Formoterol/Glycopyrrolate<br>* Active drug tested<br>* Other names: BDP/FF/GB or CHF 5993 pMDI 100/6/12.5 mcg;|
| Active Comparator: Beclometasone/Formoterol<br>Foster® 100/6 mcg 2 inhalations bid | Drug: Beclometasone/Formoterol<br>* Active comparator<br>* Other names: Foster® or CHF 1535 pMDI 100/6 mcg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dose and 2-hour post-dose morning FEV1 at week 26 and TDI score at week 26 | Change from baseline in pre-dose morning FEV1 at Week 26. Change from baseline to the 2-hour post-dose value of FEV1 at Week 26. TDI focal score at Week 26 | week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD exacerbation rate | Moderate and severe COPD exacerbation rate over 52 weeks of treatment | week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spirometry, severe COPD, lung disease, fixed combination