A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma

Study Overview
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Brief Summary
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To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a extrafine pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids

Official Title
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A 12-week, Multinational, Randomised, Double Blind, Double Dummy, 4-arm Parallel-group Study Comparing the Efficacy and Safety of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation, Via HFA Pressurised Inhalation Solution, in Moderate to Severe Symptomatic Asthmatic Patients Aged ≥ 12 Years Under Treatment With Inhaled Corticosteroids

Conditions
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Asthma

Intervention / Treatment
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* Drug: BDP/Formoterol Next DPI
* Drug: Foster
* Drug: BDP/Formoterol Next DPI
* Drug: Foster


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Outpatients of both sexes, aged > 12 years Moderate to severe symptomatic asthma Forced expiratory volume in the first second (FEV1) > 40% and < 80% of the predicted normal values Reversibility test Partly controlled asthma (GINA revised 2006) Patients free of long-acting beta2-agonists (LABAs) treatment Under inhaled corticosteroids (ICS) treatment A minimum inspiratory flow ≥ 40 L/min 10. Non-smokers or ex smokers Asthma Control Questionnaire ACQ score ≥ 1.5 Exclusion Criteria: Pregnant or nursing (lactating) women Women of child-bearing potential, UNLESS they are menopausal or have acceptable methods of contraception Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer History of near fatal asthma Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit Diagnosis COPD History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency Diagnosis of restrictive lung disease Patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids) Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids Allergy to any component of the study treatments Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ; Patients with abnormal QTc

Ages Eligible for Study
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Minimum Age: 12 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CHF 1535 Next DPI : BDP/Formoterol : 200/12 µg | Drug: BDP/Formoterol Next DPI<br>* BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)<br>|
| Active Comparator: 2<br>CHF 1535 HFA pMDI : BDP/Formoterol : 200/12 µg | Drug: Foster<br>* BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)<br>|
| Experimental: 3<br>CHF 1535 Next DPI : BDP/Formoterol : 400/24 µg | Drug: BDP/Formoterol Next DPI<br>* BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)<br>|
| Active Comparator: 4<br>CHF 1535 HFA pMDI : BDP/Formoterol : 400/24 µg | Drug: Foster<br>* BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic |  | 3 month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dose FEV1 |  | every month | 
| Post-dose FEV1 AUC 0-8 h |  | 3 month period | 
| FVC and FEF 25-75% |  | every month | 
| PEF |  | every day | 
| Morning and evening asthma clinical symptoms scores |  | every day | 
| Moderate and severe exacerbations |  | every month | 
| Rescue medication |  | every day | 
| Sputum |  | 3 month period |