Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine the triple combination of beclometasone dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of severe COPD patients (chronic obstructive pulmonary disease)

Detailed Description
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A 52-WEEK, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, 3-ARM PARALLEL GROUP, ACTIVE CONTROLLED CLINICAL TRIAL OF FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRROLATE BROMIDE ADMINISTERED VIA PMDI (CHF 5993) VERSUS TIOTROPIUM BROMIDE AND VERSUS FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE ADMINISTERED VIA PMDI AND TIOTROPIUM BROMIDE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE A total of 8 clinic visits (V0 to V7) will be performed during the study, as follows: A pre-screening visit (V0) to obtain the written informed consent from the patient A screening visit (V1) to establish the eligibility of patients, followed by a 2-week open-label run-in under Tiotropium After the randomisation (V2), patients will be assessed after 4, 12, 26, 40 and 52 weeks of treatment (V3 to V7) The assessments performed at visits include routine haematology and blood chemistry, medical history, physical examination, a 12-lead ECG, spirometric parameters, vital signs). During the run-in and the randomised treatment periods, patients use an e-diary to record symptoms, rescue medication use and compliance to the study medications daily. AEs/SAEs and COPD exacerbations will be monitored.

Official Title
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A 52-wk Randomized Double Blind Parallel Trial: Combination of Beclometasone+Formoterol+Glycopyrrolate vs Tiotropium and vs Combination of Beclometasone+Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: BDP/FF/GB
* Drug: Tiotropium
* Drug: BDP/FF + Tiotropium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female COPD patients aged ≥ 40 years Current smokers or ex-smokers FEV1<50% predicted (FEV1/FVC <0,7) at least 1 documented exacerbations in the last 12 Mo Exclusion Criteria: Pregnant or lactating women and all women physiologically capable of becoming pregnant Diagnosis of asthma, history of allergic rhinitis or atopy Patients treated for exacerbations 1 Mo prior to screening Patients treated with non-cardioselective β-blockers Patients treated with long-acting antihistamines 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: BDP/FF/GB<br>CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations b.i.d | Drug: BDP/FF/GB<br>* Superiority over Tiotropium<br>* Other names: CHF 5993 pMDI 100/6/12.5 mcg;|
| Active Comparator: Tiotropium<br>Tiotropium bromide 18 mcg | Drug: Tiotropium<br>* Superiority of CHF5993 over Tiotropium<br>* Other names: Spiriva 18 mcg 1 capsule o.d;|
| Active Comparator: BDP/FF + Tiotropium<br>BDP/FF pMDI 100/6/12.5 mcg 2 inhalations b.i.d and Tiotropium 18 mcg daily BDP/FF/GB versus BDP/FF + Tiotropium | Drug: BDP/FF + Tiotropium<br>* non inferiority vs CHF5993<br>* Other names: Foster 100/6 mcg 2 inhalations bid + Spiriva 18 mcg o.d.;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-dose morning FEV1 | Change from baseline in pre-dose morning FEV1 at Week 52. | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frequent exacerbators