MedDataX Logo

Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients.

NCT ID: NCT02487498

Last Updated: 2018-04-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-27

Study Completion Date

2016-09-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety Study of QVA149 in COPD Patients

NCT02487446

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE3

A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

NCT01727141

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation

NCT01712516

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01315249

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149

NCT01709903

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

QVA149

QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Placebo (umeclidinium/vilanterol )

Intervention Type DRUG

Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Umeclidinium/vilanterol

Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Group Type EXPERIMENTAL

Umeclidinium/vilanterol

Intervention Type DRUG

Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Placebo (QVA149)

Intervention Type DRUG

Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

QVA149

QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Intervention Type DRUG

Umeclidinium/vilanterol

Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Intervention Type DRUG

Placebo (umeclidinium/vilanterol )

Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Intervention Type DRUG

Placebo (QVA149)

Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female adults aged ≥40 yrs
* Smoking history of at least 10 pack years
* Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015)
* Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)\< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \<70%
* Modified Medical Research Council questionnaire grade of 2 or higher

Exclusion Criteria

* Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular co-morbid conditions
* Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
* Patients in the active phase of a supervised pulmonary rehabilitation program
* Patients contraindicated for inhaled anticholinergic agents and β2 agonists
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Anaheim, California, United States

Site Status

Novartis Investigative Site

Escondido, California, United States

Site Status

Novartis Investigative Site

Riverside, California, United States

Site Status

Novartis Investigative Site

San Diego, California, United States

Site Status

Novartis Investigative Site

San Diego, California, United States

Site Status

Novartis Investigative Site

San Diego, California, United States

Site Status

Novartis Investigative Site

Chiefland, Florida, United States

Site Status

Novartis Investigative Site

Clearwater, Florida, United States

Site Status

Novartis Investigative Site

Gainesville, Florida, United States

Site Status

Novartis Investigative Site

Miami, Florida, United States

Site Status

Novartis Investigative Site

Miami, Florida, United States

Site Status

Novartis Investigative Site

Winter Park, Florida, United States

Site Status

Novartis Investigative Site

Florence, Kentucky, United States

Site Status

Novartis Investigative Site

Owensboro, Kentucky, United States

Site Status

Novartis Investigative Site

North Dartmouth, Massachusetts, United States

Site Status

Novartis Investigative Site

Livonia, Michigan, United States

Site Status

Novartis Investigative Site

Saint Charles, Missouri, United States

Site Status

Novartis Investigative Site

St Louis, Missouri, United States

Site Status

Novartis Investigative Site

Lincoln, Nebraska, United States

Site Status

Novartis Investigative Site

Omaha, Nebraska, United States

Site Status

Novartis Investigative Site

Skillman, New Jersey, United States

Site Status

Novartis Investigative Site

Gastonia, North Carolina, United States

Site Status

Novartis Investigative Site

Monroe, North Carolina, United States

Site Status

Novartis Investigative Site

New Bern, North Carolina, United States

Site Status

Novartis Investigative Site

Raleigh, North Carolina, United States

Site Status

Novartis Investigative Site

Shelby, North Carolina, United States

Site Status

Novartis Investigative Site

Wilmington, North Carolina, United States

Site Status

Novartis Investigative Site

Cincinnati, Ohio, United States

Site Status

Novartis Investigative Site

Cincinnati, Ohio, United States

Site Status

Novartis Investigative Site

Eugene, Oregon, United States

Site Status

Novartis Investigative Site

Pottstown, Pennsylvania, United States

Site Status

Novartis Investigative Site

Anderson, South Carolina, United States

Site Status

Novartis Investigative Site

Charleston, South Carolina, United States

Site Status

Novartis Investigative Site

Charleston, South Carolina, United States

Site Status

Novartis Investigative Site

Easley, South Carolina, United States

Site Status

Novartis Investigative Site

Fort Mill, South Carolina, United States

Site Status

Novartis Investigative Site

Gaffney, South Carolina, United States

Site Status

Novartis Investigative Site

Greenville, South Carolina, United States

Site Status

Novartis Investigative Site

Mt. Pleasant, South Carolina, United States

Site Status

Novartis Investigative Site

Rock Hill, South Carolina, United States

Site Status

Novartis Investigative Site

Seneca, South Carolina, United States

Site Status

Novartis Investigative Site

Simpsonville, South Carolina, United States

Site Status

Novartis Investigative Site

Spartanburg, South Carolina, United States

Site Status

Novartis Investigative Site

Union, South Carolina, United States

Site Status

Novartis Investigative Site

Amarillo, Texas, United States

Site Status

Novartis Investigative Site

Boerne, Texas, United States

Site Status

Novartis Investigative Site

El Paso, Texas, United States

Site Status

Novartis Investigative Site

Fort Worth, Texas, United States

Site Status

Novartis Investigative Site

Kingwood, Texas, United States

Site Status

Novartis Investigative Site

Plano, Texas, United States

Site Status

Novartis Investigative Site

San Antonio, Texas, United States

Site Status

Novartis Investigative Site

Richmond, Virginia, United States

Site Status

Novartis Investigative Site

Greenfield, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Kerwin E, Ferguson GT, Sanjar S, Goodin T, Yadao A, Fogel R, Maitra S, Sen B, Ayers T, Banerji D. Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies. Lung. 2017 Dec;195(6):739-747. doi: 10.1007/s00408-017-0055-9. Epub 2017 Oct 9.

Reference Type DERIVED
PMID: 28993871 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CQVA149A2350

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort
NCT02516592 COMPLETED PHASE4
Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients
NCT02442206 COMPLETED PHASE4
Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
NCT00558285 COMPLETED PHASE2
A Study to Assess the Long-term Safety of QVA149
NCT01120717 COMPLETED PHASE3
Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00570778 COMPLETED PHASE2
A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01202188 COMPLETED PHASE3
Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01604278 COMPLETED PHASE3
A Multicenter, 4-week Crossover (Total Duration 12 Weeks) to Determine the Impact of QVA149 on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD)
NCT02233543 COMPLETED PHASE4
Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01294787 COMPLETED PHASE3
An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD)
NCT00636961 COMPLETED PHASE2
Efficacy of Indacaterol 150 µg Versus Formoterol
NCT01377428 WITHDRAWN PHASE4
Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00624286 COMPLETED PHASE3
Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00615030 COMPLETED PHASE3
A Cross-Over Study to Evaluate Lung Function Response After Treatment With Umeclidinium (UMEC) 62.5 Micrograms (mcg), Vilanterol (VI) 25 mcg, and Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 mcg Once-Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT02014480 COMPLETED PHASE3
Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01529632 COMPLETED PHASE3
Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)
NCT01089127 COMPLETED PHASE3
Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen
NCT01985334 COMPLETED PHASE4
Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01119950 COMPLETED PHASE2
A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
NCT01682863 COMPLETED PHASE3
Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01285492 COMPLETED PHASE3
A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01822899 COMPLETED PHASE3
A Study to Evaluate the Effect of the Combination of Umeclidinium (UMEC) and Vilanterol (VI) on Exercise Endurance Time (EET) in Participants With Chronic Obstructive Pulmonary Disease (COPD)
NCT02275052 COMPLETED PHASE4
Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide.
NCT01699685 COMPLETED PHASE3
The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01574651 COMPLETED PHASE3
Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00669617 COMPLETED PHASE3