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Completed

NCT Number: NCT02442206

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

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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Key information

Conditions

Chronic Obstructive Pulmonary Disease, COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site

Hanover, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QVA149

Drug

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

Other names: Ultibro

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: CLAIM

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 13, 2015
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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