Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients.

Detailed Description
-----------------
The primary objective is to demonstrate that CHF 1535 NEXT DPI® (beclomethasone dipropionate + formoterol fumarate 100/6 μg), 1 inhalation twice daily, is non-inferior to the corresponding dose of CHF 1535 pMDI in terms of pulmonary function test (change from baseline to the entire treatment period in average pre-dose morning PEF) in asthmatic adult patients ≥ 18 years under treatment with fixed dose combination of Foster® (beclomethasone dipropionate + formoterol fumarate 100 / 6 μg) 1 inhalation bid.

Official Title
-----------------
A Phase 3,8-week Clinical Trial to Test the Efficacy of CHF1535 Via NEXT DPI® Versus Same Dose of CHF1535 pMDI and Beclomethasone DPI 100µg on PEF in Adult Asthmatic Patients After 1 Month of Treatment With FOSTER®

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: CHF 1535 100/6 NEXT DPI® 2 months
* Drug: CHF 1535 100/6 pMDI 2 months
* Drug: BDP DPI 2 months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female adults (≥18 years old). Reversibility test defined as ΔFEV1 ≥ 12% and ≥ 200 mL . FEV1 > 80% of the predicted values . Asthma Control Questionnaire score < 1.25. Asthmatic patients Non- or ex-smokers Exclusion Criteria: History of near fatal asthma. COPD patients Asthma exacerbation within 1 month prior to the screening visit or asthma exacerbation during the run-in period. Lower respiratory tract infection within 1 month prior Visit1 (V1). 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 before V1 Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments. Significant medical history of and/or treatments Active cancer or a history of cancer .

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF 1535 100/6 NEXT Dry Powder Inhaler®<br>CHF1535 100/6 NEXT DPI® 1 inhalation bis in day (b.i.d) (daily dose BDP 200/FF 12 µg) | Drug: CHF 1535 100/6 NEXT DPI® 2 months<br>* CHF 1535 100/6 NEXT DPI® 2 months<br>|
| Active Comparator: CHF1535 100/6 pMDI<br>CHF1535 100/6 pressurisedMeterDoseInhaler 1 inhalation b.i.d (total daily dose BDP 200/FF 12 µg) | Drug: CHF 1535 100/6 pMDI 2 months<br>* CHF 1535 100/6 pMDI 2 months<br>* Other names: Foster®;|
| Active Comparator: beclomethasone dipropionate DPI<br>beclomethasone dipropionate 100 µg DPI, 1 inhalation b.i.d (total daily dose BDP 200 µg) | Drug: BDP DPI 2 months<br>* BDP DPI 2 months<br>* Other names: Clenil® Pulvinal®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow. |  | at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dose morning FEV1 (Forced Expiratory Volume in one second); |  | at 2, 4, 6 and 8 weeks of treatment | 
| Pre-dose morning FVC (Force Vital Capacity) ; |  | at 2, 4, 6 and 8 weeks of treatment | 
| ACQ (Asthma Control Questionnaire) score ; |  | at eight weeks | 
| pre-dose evening PEF ; |  | at 2, 4, 6 and 8 weeks of treatment | 
| daily PEF variability ; |  | at 2, 4, 6 and 8 weeks of treatment | 
| use of rescue medication ; |  | at 2, 4, 6 and 8 weeks of treatment | 
| percentage of rescue use-free days |  | at 2, 4, 6 and 8 weeks of treatment | 
| pre-dose morning PEF ; |  | at 2, 4, 6 and 8 weeks of treatment |