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

NCT02442206 | Completed Phase 4 Results

• 2 other identifiers: CQVA149ADE052014-004680-21
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease, COPD

Keywords

QVA149, cardiac function, ventricular enddiastolic volume, hyperinflated COPD patients

Outcome Measures

Primary Outcomes (1)

• Change in Left Ventricular End-diastolic Volume (LVEDV)

  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 Outcomes (11)

• Change in Forced Expiratory Volume in One Second (FEV1).

  Baseline, week 2

• Change in Forced Vital Capacity (FVC).

  Baseline, week 2

• Change in Inspiratory Capacity (IC) at Each Time-point

  Baseline, week 2

• Change in Total Lung Capacity (TLC)

  Baseline, week 2

• Change in Residual Volume (RVol)

  Baseline, week 2

Study Arms (2)

Treatment sequence 1

EXPERIMENTAL

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

Drug: QVA149; Drug: Placebo

Treatment sequence 2

EXPERIMENTAL

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

Drug: QVA149; Drug: Placebo

Interventions

QVA149 DRUG

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

Also known as: Ultibro

Treatment sequence 1; Treatment sequence 2

Placebo DRUG

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

Treatment sequence 1; Treatment sequence 2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Hanover, 30625, Germany

Location

Related Publications (2)

• Vogel-Claussen J, Schonfeld CO, Kaireit TF, Voskrebenzev A, Czerner CP, Renne J, Tillmann HC, Berschneider K, Hiltl S, Bauersachs J, Welte T, Hohlfeld JM. Effect of Indacaterol/Glycopyrronium on Pulmonary Perfusion and Ventilation in Hyperinflated Patients with Chronic Obstructive Pulmonary Disease (CLAIM). A Double-Blind, Randomized, Crossover Trial. Am J Respir Crit Care Med. 2019 May 1;199(9):1086-1096. doi: 10.1164/rccm.201805-0995OC.

  PMID: 30641027 DERIVED

• Hohlfeld JM, Vogel-Claussen J, Biller H, Berliner D, Berschneider K, Tillmann HC, Hiltl S, Bauersachs J, Welte T. Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM): a double-blind, randomised, crossover, placebo-controlled, single-centre trial. Lancet Respir Med. 2018 May;6(5):368-378. doi: 10.1016/S2213-2600(18)30054-7. Epub 2018 Feb 21.

  PMID: 29477448 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 13, 2015
• Study Start: May 18, 2015
• Primary Completion: April 20, 2017
• Study Completion: May 15, 2017
• Last Updated: January 3, 2019
• Results First Posted: December 3, 2018

Record last verified: 2018-12

Locations

DE (1)