Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD

Study Overview
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Brief Summary
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To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD.

Detailed Description
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The purpose of this study is to evaluate the long-term efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD. Patients are randomised to receive either beclometasone/formoterol or budesonide/formoterol DPI or formoterol DPI during 48 weeks of treatment.

Official Title
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A 48-week, Double Blind, Double Dummy, Randomised, Multinational, Multicentre, 3-arm Parallel Group Clinical Study of Fixed Combination Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant Versus Fixed Combination Budesonide Plus Formoterol DPI Versus Formoterol DPI in Patients With Stable Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
* Drug: Budesonide 200 µg plus formoterol 6 µg DPI
* Drug: Formoterol 12 µg DPI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of COPD (according to GOLD guidelines) FEV1 > or equal 30% and < 50% of predicted normal post-bronchodilator (and at least 0.7 L absolute value) COPD symptoms for at least 2 years At least 1 exacerbation requiring medical intervention (oral corticosteroid and/or antibiotic treatment and/or need for a visit to an emergency department and/or hospitalization) within 2-12 months before screening Current or previous smoker with a cumulative exposure to smoke of more than 20-pack year Exclusion Criteria: Current or past diagnosis of asthma, or any evidence suggestive of asthma Positive FEV1 reversibility test Clinically significant or unstable concurrent diseases, including clinically significant laboratory abnormalities Acute COPD exacerbation or lower tract infection and/or treatment with oral or injectable corticosteroids and antibiotics in the 2 months before screening or during run-in Long term oxygen therapy

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: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI<br> | Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI<br>* Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) two puffs via oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.<br>Drug: Budesonide 200 µg plus formoterol 6 µg DPI<br>* two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.<br>Drug: Formoterol 12 µg DPI<br>* one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.<br>|
| Active Comparator: Budesonide 200 µg plus formoterol 6 µg DPI<br> | Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI<br>* Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) two puffs via oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.<br>Drug: Budesonide 200 µg plus formoterol 6 µg DPI<br>* two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.<br>Drug: Formoterol 12 µg DPI<br>* one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.<br>|
| Active Comparator: Formoterol 12 µg DPI<br> | Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI<br>* Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) two puffs via oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.<br>Drug: Budesonide 200 µg plus formoterol 6 µg DPI<br>* two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.<br>Drug: Formoterol 12 µg DPI<br>* one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of COPD exacerbations and pre-dose morning FEV1 |  | one year treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other pulmonary function parameters, |  | one year treatment | 
| COPD symptom scores and Quality of Life, |  | one year treatment | 
| safety and tolerability |  | one year treatment |