Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder

Inclusion criteria

• Diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2011
• Asthmatic patients already treated with low daily doses of Inhaled Corticosteroids (ICS) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ICS/Long Acting Beta2 Agonists (LABA) fixed combinations.
• Patients with Forced Expiratory Volume in 1 sec (FEV1) >= 70 % of predicted values
• Non or ex-smokers
• Body Mass Index (BMI) >= 18.5 and <= 32 kg/m2

Exclusion criteria

• Pregnant or lactating women unless using acceptable methods of contraception
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
• History of near fatal asthma
• Patients with abnormal QTcF at screening Visit
• Hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
• Lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period.
• History of drug addiction or excessive use of alcohol ;
• Diagnosis of restrictive lung disease.
• Patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids)
• Significant medical history or any laboratory abnormality indicative of a significant underlying condition