Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol
Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol
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