Dose Ranging Study for Indacaterol in Japanese Asthma Patients

A Randomized, Double-blind, Placebo-controlled, 4-period 4-treatment Crossover, Multicenter, Single-dose, Dose-ranging Study Followed by a Single Day's Treatment With Open Label Salmeterol Bid (100 µg/Day), to Assess the Efficacy and Safety of 3 Doses of Indacaterol (150, 300, & 600 µg) Delivered Via Single Dose Dry Powder Inhaler (SDDPI) in Japanese Asthma Patients

This study was designed to provide data about the safety and efficacy of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or doses, could be chosen for testing in later studies.

Inclusion Criteria:

• Male and female Japanese asthmatic patients aged 18 to 75 years old.

Exclusion Criteria:

• Patients who have been hospitalized or had emergency room treatment for an acute asthma attack in the 6 months prior to the first day of screening or during the screening period.
• Patients who have used tobacco products within 6 months prior to the first day of screening or have a smoking history of greater than 10 pack years.
• Patients with a history of malignancy with the exception of localized basal cell carcinoma of the skin.
• Pregnant or nursing (lactating) women.
• Patients who have had treatment with disallowed medications including investigational drug.

Other protocol-defined inclusion/exclusion criteria applied to the study.