Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

Multicenter, Randomized, Blinded, Placebo-controlled, Crossover, Single-dose Study to Assess the Effect of Indacaterol (150 μg) Versus Tiotropium (18 μg) on Inspiratory Capacity in Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients

This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.

Inclusion Criteria:

• Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:

  1. Smoking history of at least 10 pack-years.
  2. Forced expiratory volume in 1 second (FEV1) < 80% and ≥ 50% of the predicted normal value.
  3. Post-bronchodilator FEV1/Force vital capacity (FVC) < 0.7.

Exclusion Criteria:

• Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening.
• Patients who have had a respiratory tract infection within 6 weeks prior to screening.
• Patients with concomitant pulmonary disease.
• Patients with alpha-1-antitrypsin deficiency.
• Patients with contraindications for tiotropium treatment.
• Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes.

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