A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device

A Multi-centre, Randomized, Double-blind, Double-dummy, Multiple-dose, Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Orally Inhaled Indacaterol Administered as Either PulmoSphere or Lactose-blend Powder Via the Concept1 Device in Adult Patients With Persistent Asthma

This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.

Inclusion Criteria:

• Male and female patients with asthma
• Aged 18 or above
• Patients using inhaled corticosteroid (with or without long acting beta agonist)
• Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist

Exclusion Criteria:

• Asthma exacerbations in previous 6 months
• COPD or other pulmonary disease
• Excessive use of short acting beta agonists