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



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:3/31/2017
Start Date:July 27, 2015
End Date:September 6, 2016

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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.

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.


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

- Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
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Anaheim, California 92801
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Amarillo, Texas 79106
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Anderson, South Carolina 29621
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Boerne, Texas 78006
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Charleston, South Carolina 29407
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Charleston, South Carolina 29407
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Chiefland, Florida 32626
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Cincinnati, Ohio 45229
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Cincinnati, Ohio 45229
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Clearwater, Florida 33756
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Easley, South Carolina 29640
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El Paso, Texas 79902
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Escondido, California 92025
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Eugene, Oregon 97401
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Florence, Kentucky 41042
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Fort Mill, South Carolina 29707
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Ft. Worth, Texas 76104
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Gaffney, South Carolina 29340
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Gainesville, Florida 32608
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Gastonia, North Carolina 28054
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Greenfield, Wisconsin 53228
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Greenville, South Carolina 29605
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Kingwood, Texas 77339
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Lincoln, Nebraska 68506
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Livonia, Michigan 48152
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Miami, Florida 33136
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Miami, Florida 33136
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Monroe, North Carolina 28112
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Mt. Pleasant, South Carolina 29464
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New Bern, North Carolina 28562
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North Dartmouth, Massachusetts 02747
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Omaha, Nebraska 68144
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Owensboro, Kentucky 42301
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Plano, Texas 75024
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Pottstown, Pennsylvania 19464
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Raleigh, North Carolina 27609
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Richmond, Virginia 23249
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Riverside, California 92506
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Rock Hll, South Carolina 29732
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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San Diego, California 92123
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San Diego, California 92123
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San Diego, California 92123
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Seneca, South Carolina 29678
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Shelby, North Carolina 28152
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Simpsonville, South Carolina 29681
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Skillman, New Jersey 08558
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Spartanburg, South Carolina 29302
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St. Charles, Missouri 63301
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St. Louis, Missouri 63110
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Union, South Carolina 29379
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Wilmington, North Carolina 28401
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Winter Park, Florida 32789
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