A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients

• Status: Completed
• Trial end date: 2018-06-04
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg once daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min and 15 min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic COPD patients

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Bromides; Glycopyrrolate; Maleic acid; Tiotropium Bromide

Criteria

Inclusion Criteria:

• Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 50% of the predicted normal value and post-bronchodilator FEV1/FVC < 0.7 (COPD Grade 1 or 2 by severity of airflow limitation (GOLD 2015)

• Patients with CAT score ≥ 10 at Visit 0 and Visit 1.

• Patients who are on and have been on tiotropium monotherapy for the past 3 months.

• 0 or 1 COPD exacerbation in the previous 12 months (not leading to hospital admission).

Exclusion Criteria:

• Treatment with any inhaled corticosteroid (ICS) in the 3 months prior to Visit 1.

• COPD exacerbation between Visit 0 and 1.

• Patients with concomitant pulmonary disease

• Patients with a history of respiratory infection within 4 weeks prior to Visit 0.

• Prior or current diagnosis of asthma.

• Presence of any contraindication, warning, precaution, hypersensitivity to LABA and LAMA

Other protocol-defined inclusion/exclusion criteria may apply