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

COMPLETEDPHASE3

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

A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, Two-period Cross-over Study to Assess the Efficacy, Safety and Tolerability of Indacaterol Maleate/Glycopyrronium Bromide Compared to Umeclidinium Bromide/Vilanterol in COPD Patients With Moderate to Severe Airflow Limitation.

NCT02487498•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (53)

Novartis Investigative Site

Anaheim, California, United States

Novartis Investigative Site

Escondido, California, United States

Novartis Investigative Site

Riverside, California, United States

Novartis Investigative Site

San Diego, California, United States

Novartis Investigative Site

San Diego, California, United States

Novartis Investigative Site

San Diego, California, United States

Novartis Investigative Site

Chiefland, Florida, United States

Novartis Investigative Site

Clearwater, Florida, United States

Novartis Investigative Site

Gainesville, Florida, United States

Novartis Investigative Site

Miami, Florida, United States

Key Dates

Start Date

July 27, 2015

Primary Completion Date

September 6, 2016

Completion Date

September 6, 2016

Last Updated

April 2, 2018

Enrollment

355

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

QVA149

DRUG

Umeclidinium/vilanterol

DRUG

Placebo (umeclidinium/vilanterol )

DRUG

Placebo (QVA149)

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

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RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Probiotics in Pulmonaty Rehabilitation for COPD

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