Phase 4
Completed N=379
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
Source: ClinicalTrials.gov NCT02566031 ↗Enrolled (actual)
379
Serious AEs
2.9%
Results posted
Sep 2019
Primary outcomePrimary: Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment — 0.0668; 0.0090 Liters — p=0.0129
◆ Published Evidence
Emerging
3citations · ~0 / year
Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trial.
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
Linked Publications
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Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment |
0.0668; 0.0090 | 0.0129 sig |
| SECONDARY Trough Forced Expiratory Volume In One Second (FEV1) After 4 Weeks of Treatment |
0.087; 0.026; 0.077; 0.024 | 0.0058 sig |
| SECONDARY Baseline Transitional Dyspnea Index (TDI) Focal Score |
0.77; 0.61 | 0.0767 |
| SECONDARY Number of Participants With Change From Baseline on Total Score of COPD Assessment Test (CAT) |
62; 54; 92; 101; 15; 22 | 0.1008 |
| SECONDARY Daily Rescue Medication Use (Number of Puffs) |
1.7; 1.8 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02566031) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.