Tempe, Arizona 85283

  • Chronic Obstructive Pulmonary Disease


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



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Tempe, Arizona 85283
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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