Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device. The study aimed to determine whether the novel formulation (Simoon) had a similar profile to that of the established formulation (Concept1).

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Maleic acid

Criteria

Inclusion criteria:

• Patients with persistent asthma with a forced expiratory volume in 1 second (FEV1) ≥ 50%

• Patients using inhaled corticosteroid (with or without long-acting beta agonist)

Exclusion criteria:

• Asthma exacerbations in previous 6 months

• Chronic obstructive pulmonary disease (COPD) or other pulmonary disease

• Excessive use of short-acting beta agonists

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