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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-18

Study Completion Date

2017-05-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease, COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment sequence 1

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

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Treatment sequence 2

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

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

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QVA149

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Ultibro

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No