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

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®

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.

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.

Inclusion Criteria:

1. Male and female adults (≥18 years old).
2. Reversibility test defined as ΔFEV1 ≥ 12% and ≥ 200 mL .
3. FEV1 > 80% of the predicted values .
4. Asthma Control Questionnaire score < 1.25.
5. Asthmatic patients
6. Non- or ex-smokers

Exclusion Criteria:

1. History of near fatal asthma.
2. COPD patients
3. Asthma exacerbation within 1 month prior to the screening visit or asthma exacerbation during the run-in period.
4. Lower respiratory tract infection within 1 month prior Visit1 (V1).
5. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
6. Diagnosis of restrictive lung disease.
7. Patients treated with oral or parenteral corticosteroids in the previous 2 months before V1
8. Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments.
9. Significant medical history of and/or treatments
10. Active cancer or a history of cancer .