Effect of Indacaterol on Inspiratory Capacity (IC)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In particular, spirometric timepoints are included to elucidate the peak-IC in a period of approximately 4 hour post inhalation

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Tiotropium Bromide

Criteria

Inclusion Criteria:

• Co-operative outpatients with a diagnosis of COPD (moderate as classified by the GOLD Guidelines, 2008) and including:

• Smoking history of at least 10 pack years

• Post-bronchodilator FEV1 <80% and ≥50% of the predicted normal value (Visit 2).

• Post-bronchodilator FEV1/forced vital capacity (FVC) <70% (Visit 2).

Exclusion Criteria:

• Patients who received any corticosteroid (including inhaled) for 3 months prior to screening

Other protocol-defined inclusion/exclusion criteria may apply