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

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ClinicalTrials.gov Identifier: NCT02442206
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : December 3, 2018
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease, COPD Drug: QVA149 Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : May 18, 2015
Actual Primary Completion Date : April 20, 2017
Actual Study Completion Date : May 15, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Ultibro

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442206


Locations
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Germany
Novartis Investigative Site
Hannover, Germany, 30625
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] November 9, 2016
Study Protocol  [PDF] April 20, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02442206    
Other Study ID Numbers: CQVA149ADE05
2014-004680-21 ( EudraCT Number )
First Posted: May 13, 2015    Key Record Dates
Results First Posted: December 3, 2018
Last Update Posted: January 3, 2019
Last Verified: December 2018
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
QVA149, cardiac function, ventricular enddiastolic volume, hyperinflated COPD patients
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases