Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

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

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Tiotropium Bromide

Criteria

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.