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

• 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 .