Dose Ranging Study for Indacaterol in Japanese Asthma Patients

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Salmeterol Xinafoate

Criteria

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.