Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with persistent asthma. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Maleic acid

Criteria

Inclusion Criteria:

• Males and females 12 - 75 years of age with a diagnosis of persistent asthma

• Daily treatment with a bronchodilator and daily dose of at least 100 µg beclomethasone dipropionate or equivalent

• FEV1 at Visit 1 at least 50% of the predicted normal value

• FEV1 reversibility at least 15%

Exclusion Criteria:

• Use of tobacco products within 6 months prior to Visit 1 or a smoking history of more than 10 pack years

• Chronic Obstructive Pulmonary Disease (COPD)

• Seasonal allergy where asthma is likely to deteriorate during the period of the study

• Emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months

• A respiratory tract infection within the previous 6 weeks Other protocol-defined exclusion criteria may apply