Phase 4
Completed N=62
Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients
Source: ClinicalTrials.gov NCT02442206 ↗Enrolled (actual)
62
Serious AEs
2.8%
Results posted
Dec 2018
Primary outcomePrimary: Change in Left Ventricular End-diastolic Volume (LVEDV) — 11.873; -0.954 ML — p=<0.0001
◆ Published Evidence
Highly cited
182citations · ~23 / year
Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM): a double-blind, randomised, crossover, placebo-controlled, single-centre trial.
Summary
This mechanistic study is a single-center, randomized, double-blind, placebo-controlled, cross-over study to evaluate the effect of dual bronchodilation with QVA149 on cardiac and lung function parameters in hyperinflated COPD patients.
Linked Publications (2)
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Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM): a double-blind, randomised, crossover, placebo-controlled, single-centre trial.
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Effect of Indacaterol/Glycopyrronium on Pulmonary Perfusion and Ventilation in Hyperinflated Patients with Chronic Obstructive Pulmonary Disease (CLAIM). A Double-Blind, Randomized, Crossover Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricular End-diastolic Volume (LVEDV) |
11.873; -0.954 | <0.0001 sig |
| SECONDARY Change in Forced Expiratory Volume in One Second (FEV1). |
0.42; -0.01 | <0.0001 sig |
| SECONDARY Change in Forced Vital Capacity (FVC). |
0.67; 0.00 | <0.0001 sig |
| SECONDARY Change in Inspiratory Capacity (IC) at Each Time-point |
0.475; 0.014 | <0.0001 sig |
| SECONDARY Change in Total Lung Capacity (TLC) |
-0.181; -0.001 | 0.0017 sig |
| SECONDARY Change in Residual Volume (RVol) |
-0.757; 0.012 | <0.0001 sig |
| SECONDARY Change in Specific Airway Resistance (sRaw) |
-1.887; 0.037 | <0.0001 sig |
| SECONDARY Change in Functional Residual Capacity (FRC) |
-0.656; -0.015 | <0.0001 sig |
| SECONDARY Change in Right Ventricular (RV) and Left Ventricular (LV) Ejection Fraction (EF) |
1.893; 1.313; 2.046; 0.361 | 0.1420 |
| SECONDARY Change in Left and Right Ventricular End-systolic Volume |
1.898; -2.283; 2.183; 0.133 | 0.0437 sig |
| SECONDARY Change in Right Ventricular Enddiastolic Volume |
12.323; 1.758 | 0.0002 sig |
| SECONDARY Cardiac Output at Each Time-point, Left and Right Ventricular Cardiac Output (LVCO and RVCO) |
0.504; 0.119; 0.517; 0.144 | 0.0032 sig |
Eligibility Criteria
Inclusion Criteria
- Patients with airflow limitation indicated by a post-bronchodilator FEV1 135% predicted
Exclusion Criteria
- Patients on LABA or LAMA treatment at Visit 1.
- History of one COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization 3 months prior to Visit 2.
- More than one COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization within 6 months prior to Visit 2.
- Patients who have clinically significant cardiovascular abnormalities, which could interfere with the assessment of the study treatment (such as but not limited to cardiac arrhythmias, heart failure with left ventricular ejection fraction 450 ms for males and >470 ms for females
Additional study-specific inclusion and exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02442206) 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.