Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients

Study Overview
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Brief Summary
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Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over

Detailed Description
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To demonstrate the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT DPI and CHF 1535 via HFA-134a extrafine pMDI in partly controlled adult asthmatic patients

Official Title
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A Phase II, Multinational, Multicentre, Double Blind, Double Dummy, Randomised, 5-way Cross-over, Placebo and Active Controlled Clinical Study to Test the Non-inferiority of a Single Dose of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg Dry Powder) Via NEXT™ DPI 1 or 4 Inhalations Versus CHF 1535 (Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg) pMDI With HFA-134a Propellant 1 or 4 Puffs on FEV1 AUC0-12h in Partly Controlled Adult Asthmatic Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: CHF 1535 Next DPI
* Drug: Foster BDP/Formoterol
* Drug: CHF 1535 Next DPI
* Drug: Foster BDP/Formoterol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient's written informed consent obtained prior to any study-related procedures. Outpatient male or female aged ≥ 18 years. Evidence for partly controlled asthma in the 2 weeks before the screening visit Under previous inhaled corticosteroids (ICS) treatment at the screening visit Forced expiratory volume in the first second (FEV1) ≥ 60% and ≤ 90% of the predicted normal values at the screening visit. A documented positive response to the reversibility test at the screening visit, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, 30 minutes after 400 μg salbutamol pMDI Patients free of long-acting beta2-agonists (LABAs) treatment for at least 2 weeks before the screening visit. Patients free of short-acting beta2-agonists (SABAs) treatment for at least 6 hours before the screening visit. Non-smokers or ex-smokers Exclusion Criteria: Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they are menopausal or are using effective and 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 (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit) within 1 year before screening. Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit. Diagnosis of Chronic Obstructive Pulmonary Disease (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 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit. Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids. Allergy, sensitivity or intolerance to study drugs or excipients. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality.

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CHF 1535 DPI : BDP/Formo 400/24 µg | Drug: CHF 1535 Next DPI<br>* CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)<br>|
| Active Comparator: 2<br>CHF 1535 pMDI HFA : BDP/Formo 400/24 µg | Drug: Foster BDP/Formoterol<br>* BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)<br>|
| Experimental: 3<br>CHF 1535 DPI : BDP/Formo 100/6 µg | Drug: CHF 1535 Next DPI<br>* CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg)<br>|
| Active Comparator: 4<br>CHF 1535 pMDI HFA : BDP/Formo 100/6 µg | Drug: Foster BDP/Formoterol<br>* BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg<br>|
| Placebo Comparator: 5<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 AUC0-12h |  | Every week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FVC as assessed at the same time points as for FEV1; Peak FEV1 in terms of absolute values and % of change from baseline Safety evaluation |  | Every week |