Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients (CLAIM)

Novartis

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease, COPD

Treatments: Drug: Placebo; Drug: QVA149

Study type: Interventional

Funder types: Industry

Identifiers

NCT02442206

2014-004680-21 (EudraCT Number)

CQVA149ADE05

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with airflow limitation indicated by a post-bronchodilator FEV1 <80% of the predicted normal value and a post-bronchodilator FEV1/FVC<0.7
• Current or ex-smokers who have a smoking history of at least 10 pack years.
• Able and willing to give written informed consent
• Hyperinflated patients with RVol>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 <40% as determined by MRI scan, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, history of myocardial infarction 6 months prior to Visit 2)
• Patients with a known history or current atrial fibrillation to be confirmed by ECG.
• Patients with pacemaker, bypass or stent.
• Patients whose QTcF measured at Visit 3 is >450 ms for males and >470 ms for females

Additional study-specific inclusion and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups

Treatment sequence 1

Experimental group

Description:

QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43

Treatment:

Drug: QVA149

Drug: Placebo

Treatment sequence 2

Experimental group

Description:

Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43

Treatment:

Drug: QVA149

Drug: Placebo