Efficacy and Safety of Different Doses of Indacaterol
Efficacy and Safety of Different Doses of Indacaterol
This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo
 and salmeterol
Inclusion Criteria:

 -  Patients with a diagnosis of asthma, and:

 1. Receiving daily treatment with inhaled corticosteroid in a regimen that has been
 stable for at least a month prior to screening

 2. Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening ≥50
 and ≤90% of predicted normal

 3. An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30
 minutes after inhaling albuterol

 Exclusion Criteria:

 -  Smoking history >10 pack-years

 -  Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)

 -  Patients with seasonal allergy whose asthma is likely to deteriorate during the study
 period

 -  Patients who have experienced a severe asthma attack/exacerbation requiring
 hospitalization in the 6 months prior to screening

 -  Patients who have had an intubation for a severe asthma exacerbation

 -  Patients who have had an emergency room visit for an asthma attack/asthma exacerbation
 within 6 weeks prior to screening

 -  Patients who have had a respiratory tract infection within 6 weeks prior to screening

 -  Patients with concomitant pulmonary disease

 -  Patients with diabetes Type I or uncontrolled diabetes Type II

 -  Any patient with lung cancer or a history of lung cancer

 -  Patients with a history of certain cardiovascular comorbid conditions

 -  Patients who have ever received or are currently receiving omalizumab or chronic oral
 corticosteroid therapy

 Other protocol-defined inclusion/exclusion criteria may apply