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

December 10, 2018 updated by: Novartis Pharmaceuticals

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment sequence 1
QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43
Drug: QVA149
QVA149 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily
Other Names:
  • Ultibro
Drug: Placebo
Placebo to QVA140 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily
Experimental: Treatment sequence 2
Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43
Drug: QVA149
QVA149 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily
Other Names:
  • Ultibro
Drug: Placebo
Placebo to QVA140 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Left Ventricular End-diastolic Volume (LVEDV)
Time Frame: Baseline, week 2
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.
Baseline, week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Forced Expiratory Volume in One Second (FEV1).
Time Frame: Baseline, week 2
Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by spirometry.
Baseline, week 2
Change in Forced Vital Capacity (FVC).
Time Frame: Baseline, week 2
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.
Baseline, week 2
Change in Inspiratory Capacity (IC) at Each Time-point
Time Frame: Baseline, week 2
Inspiratory capacity (IC) was defined as the mean of the maximum IC over 3 values measured by bodyplethysmography according to internationally accepted standards.
Baseline, week 2
Change in Total Lung Capacity (TLC)
Time Frame: Baseline, week 2
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.
Baseline, week 2
Change in Residual Volume (RVol)
Time Frame: Baseline, week 2
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.
Baseline, week 2
Change in Specific Airway Resistance (sRaw)
Time Frame: Baseline, week 2
Specific Airway Resistance (sRaw) will be documented as effective resistance (sReff) calculated as the median of five acceptable measurements. Values will be measured by body plethymography according to internationally accepted standards.
Baseline, week 2
Change in Functional Residual Capacity (FRC)
Time Frame: Baseline, week 2
Functional Residual Capacity (FRC) will be calculated as the mean of three reproducible values as measured by body plethymography according to internationally accepted standards.
Baseline, week 2
Change in Right Ventricular (RV) and Left Ventricular (LV) Ejection Fraction (EF)
Time Frame: Baseline, week 2
Right and left ventricular ejection fraction is the fraction of blood (in percent) pumped out of the heart's left and right ventricular chamber, respectively, with each heart beat and will be determined as measured by MRI.
Baseline, week 2
Change in Left and Right Ventricular End-systolic Volume
Time Frame: Baseline, week 2
Right ventricular end-systolic volume (RV-ESV) and left ventricular end-systolic volume (LV-ESV) is a measurement of the volume of blood in the heart's right and left ventricular chamber, respectively, at the end of the heart's contraction and will be determined as measured by MRI.
Baseline, week 2
Change in Right Ventricular Enddiastolic Volume
Time Frame: Baseline, week 2
Right ventricular end-diastolic volume is a measurement of the volume of blood in the heart's right ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI.
Baseline, week 2
Cardiac Output at Each Time-point, Left and Right Ventricular Cardiac Output (LVCO and RVCO)
Time Frame: week 2
Cardiac output is calculated as the heart rate multiplied by the stroke volume (= difference between ventricular enddiastolic volume and endsystolic volume) that will be determined as measured by MRI.
week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2015

Primary Completion (Actual)

April 20, 2017

Study Completion (Actual)

May 15, 2017

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Actual)

January 3, 2019

Last Update Submitted That Met QC Criteria

December 10, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQVA149ADE05
  • 2014-004680-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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