Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.

• Phase: Phase 1

Details

• Lead Sponsor: Novartis
• Treatments: Maleic acid

Criteria

Inclusion Criteria:

• Male and female patients 18 to 65 years old (inclusive)

• Patients with mild to moderate persistent asthma

• BMI must be within the range of 18-32 kg/m2 inclusive

• Female subjects must:

1. have been sterilized at least 6 months prior to screening

2. be post-menopausal with no regular bleeding for at least a year prior to inclusion

Exclusion Criteria:

• Patients with life-threatening arrhythmias

• Patients with COPD or diabetes mellitus

• History of immunocompromise, including a positive HIV

• A positive Hepatitis B surface antigen (HBsAg) of Hepatitis C test result

Other protocol-defined inclusion/exclusion criteria may apply.