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Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

A Randomized, Double-blinded, Single-center, Placebo Controlled, Cross-over Study to Assess the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) on Cardiac Function in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02442206•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - No limit years

Sex

ALL

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

Locations (1)

Novartis Investigative Site

Hanover, Germany

Key Dates

Start Date

May 18, 2015

Primary Completion Date

April 20, 2017

Completion Date

May 15, 2017

Last Updated

January 3, 2019

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease, COPD

Interventions

QVA149

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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