Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Repeated-dose Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Three Different Dosing Regimens of Inhaled Indacaterol Maleate in Patients With Persistent Asthma

This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma

Inclusion Criteria:

• Patients with a diagnosis of asthma and:
• Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
• FEV1 ≥50% and ≤90% of predicted normal at screening
• An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling a total dose of albuterol/salbutamol of 360/400 MDI

Exclusion Criteria:

• Smoking history of ≥ 10 years
• Patients with a diagnosis of COPD
• Patients who have been previously intubated for a severe asthma exacerbation/ attack
• Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
• Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening
• Patients who have had a respiratory tract infection within 6 weeks prior to screening
• Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
• Patients with Type I or uncontrolled Type II diabetes mellitus

Other protocol-defined inclusion/exclusion criteria may apply