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COMPLETEDPHASE3

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

A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT01315249•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Smoking history of at least 10 pack years
•Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2009)
•Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) \>40% and \< 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) \<70%

Exclusion Criteria

•Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
•Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
•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 (within last 5 years)
•Patients with a history of certain cardiovascular co-morbid conditions

Locations (93)

Novartis Investigative Site

Malmedy, Belgium, Belgium

Novartis Investigative Site

Luxembourg, Luxembourg, Belgium

Novartis Investigative Site

Aalst, Belgium

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Hasselt, Belgium

Novartis Investigative Site

Jambes, Belgium

Novartis Investigative Site

Jette, Belgium

Novartis Investigative Site

Cvikov, Czech Republic, Czechia

Novartis Investigative Site

Jindřichův Hradec, Czech Republic, Czechia

Novartis Investigative Site

Mělník, Czech Republic, Czechia

Key Dates

Start Date

March 1, 2011

Primary Completion Date

March 1, 2012

Completion Date

March 1, 2012

Last Updated

August 9, 2013

Enrollment

523

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

indacaterol and glycopyrronium (QVA149)

DRUG

Placebo to fluticasone/salmeterol

DRUG

fluticasone/salmeterol

DRUG

Placebo to indacaterol and glycopyrronium (QVA149)

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGNA

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

NCT07382258

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

Mindful-Breath for People With COPD

NCT07195838

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: August 9, 2013Data 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

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

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A