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

A Randomized, Partially-blinded, Single-dose, 4-way Cross-over Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Maleate Administered Via the Concept1 Device or Via the Simoon Device

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).

This study was double-blind with regards to the Concept1, where placebo for the lactose-blended indacaterol was available. However, with regards to the Simoon, neither the subject nor the investigator was blinded due to lack of a placebo to the PulmoSphere formulation. Hence, the overall designation of the study was partially-blind.

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.