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

Novartis

Status and phase: Completed; Phase 4

Conditions: COPD

Treatments: Drug: Tiotropium; Drug: Indacaterol and glycopyrronium (QVA149)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02566031

CQVA149AKR01

Details and patient eligibility

About

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

Enrollment: 379 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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379 participants in 2 patient groups

Indacaterol and glycopyrronium (QVA149)

Experimental group

Description:

QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks

Treatment:

Drug: Indacaterol and glycopyrronium (QVA149)

Tiotropium

Active Comparator group

Description:

Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks

Treatment:

Drug: Tiotropium