ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02442206
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 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 : May 15, 2017
Actual Study Completion Date : May 15, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Left ventricular enddiastolic volume (LVEDV) [ Time Frame: 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. Forced Expiratory Volume in one second (FEV1) at each time-point [ Time Frame: 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. Forced Vital Capacity (FVC) at each time-point [ Time Frame: 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. Inspiratory Capacity (IC) at each time-point [ Time Frame: 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. Total Lung Capacity (TLC) at each time-point [ Time Frame: 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 bodyplethymography according to internationally accepted standards.

  5. Residual Volume (RVol) at each time-point [ Time Frame: 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 bodyplethymography according to internationally accepted standards.

  6. Specific Airway Resistance (sRaw) at each time-point [ Time Frame: 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 bodyplethymography according to internationally accepted standards.

  7. Functional Residual Capacity (FRC) at each time-point [ Time Frame: week 2 ]
    Functional Residual Capacity (FRC) will be calculated as the mean of three reproducible values as measured by bodyplethymography according to internationally accepted standards.

  8. Right and left ventricular ejection fraction at each time-point [ Time Frame: 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. Ricght and left ventricular endsystolic volumes at each time-point [ Time Frame: week 2 ]
    Right and left ventricular endsystolic volume 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. Right ventricular enddiastolic volume at each time-point [ Time Frame: week 2 ]
    Right ventricular enddiastolic 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 [ 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


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
Germany
Novartis Investigative Site
Hannover, Germany, 30625
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02442206     History of Changes
Other Study ID Numbers: CQVA149ADE05
2014-004680-21 ( EudraCT Number )
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
QVA149, cardiac function, ventricular enddiastolic volume, hyperinflated COPD patients

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Maleic acid
Glycopyrrolate
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs