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

Novartis Pharmaceuticals62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease, COPD

Interventions

QVA149DRUG

QVA149 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily

PlaceboDRUG

Placebo to QVA140 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigative Site

Hanover, Germany

Outcomes

Primary Outcomes

Change in Left Ventricular End-diastolic Volume (LVEDV)

Left ventricular enddiastolic volume (LVEDV) is a measurement of the volume of blood in the heart's left ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI.

Time frame: Baseline, week 2

Secondary Outcomes

Change in Forced Expiratory Volume in One Second (FEV1).

Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by spirometry.

Time frame: Baseline, week 2

Change in Forced Vital Capacity (FVC).

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry.

Time frame: Baseline, week 2

Change in Inspiratory Capacity (IC) at Each Time-point

Inspiratory capacity (IC) was defined as the mean of the maximum IC over 3 values measured by bodyplethysmography according to internationally accepted standards.

Time frame: Baseline, week 2

Change in Total Lung Capacity (TLC)

Total Lung Capacity (TLC) will be calculated from the mean Functional Residual Capacity (FRC) plus the highest value of the Inspiratory Capacity, both measured by body plethymography according to internationally accepted standards.

Time frame: Baseline, week 2

Change in Residual Volume (RVol)

Residual Volume (RVol) will be calculated from the value of Total Lung Capacity (TLC) minus the highest value of the Slow Vital Capacity, both measured by body plethymography according to internationally accepted standards.

Data from ClinicalTrials.gov

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