Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients

Study Overview
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Brief Summary
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The purpose of this study is to show the superiority of CHF 1535 (BDP/FF) pMDI over BDP HFA pMDI in terms of lung function considering change from baseline to the entire treatment period in average pre-dose morning PEF in adult asthmatic patients not adequately controlled on high doses of ICS or on medium dose of ICS+LABA.

Official Title
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A 12-week, Multinational, Multicentre, Randomised, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of CHF 1535 200/6µg Versus Beclomethasone Dipropionate in Adult Asthmatic Patients Not Adequately Controlled on High Dose of Inhaled Corticosteroids or on Medium Dose of Inhaled Corticosteroids Plus Long-acting β2 Agonists

Conditions
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Asthma

Intervention / Treatment
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* Drug: CHF1535 200/6 µg
* Drug: BDP 100 µg


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Male or female patients aged > 18 years. Patients with persistent asthma not optimally controlled (GINA 2010) on high doses of ICS or medium dose of ICS+LABA at a stable dose for at least 4 weeks prior to screening. Patients with FEV1 >= 40% and < 80% of predicted for the patient normal value and at least 0.9 L. Patients with a documented positive response to the reversibility test, defined as ΔFEV1 >= 12% and >= 200 mL over baseline, within 30 minutes after administration of 400 μg of salbutamol pMDI. At screening and at the end of the run-in period, patients with not adequately controlled asthma according to GINA 2010 and with score at the Asthma Control Questionnaire (ACQ)> 0.75 Main Exclusion Criteria: History of near fatal asthma or of a past hospitalisation for asthma in Intensive Care Unit or of frequent exacerbations (3 or more asthma exacerbations/ year). Hospitalisation, Emergency Room admission or use of systemic steroids (more than 3 days) for asthma exacerbation in the 4 weeks prior to screening visit and during the run-in period. Symptomatic infection of the lower airways in the 4 weeks before the screening visit. Current or ex-smokers with total cumulative exposure equal or more than 5 pack-years and /or having stopped smoking one year or less prior to screening visit. Patients with a clinically significant abnormality at 12-lead ECG or presenting a QTcB interval value in ECG > 450 msec in males or > 470 msec in females).

Ages Eligible for Study
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Minimum Age: 18 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 1535 200/6µg<br> | Drug: CHF1535 200/6 µg<br>* CHF 1535 (BDP/FF) 800/24 µg daily during 12 weeks<br>|
| Active Comparator: BDP 100µg<br> | Drug: BDP 100 µg<br>* Beclomethasone Dipropionate 800µg daily during 12 weeks<br>* Other names: Qvar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dose morning PEF | Change from baseline to the entire treatment period in average pre-dose morning PEF | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dose morning FEV1 | Change from baseline in pre-dose morning FEV1 every two weeks over a 12-week period | 2 weeks | 
| Asthma symptoms | Asthma symptoms collected day and night-time | 12 weeks | 
| Adverse Events | Adverse Events | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adults, not adequately controlled, pre-dose morning PEF