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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT02487498

Run by

Novartis Pharmaceuticals

People needed

355

Starts

2015-07-27

Expected to finish

2016-09-06

Last updated by the study team

2018-04-02

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Winter Park, Florida, United States
• Novartis Investigative Site — Florence, Kentucky, United States
• Novartis Investigative Site — Owensboro, Kentucky, United States
• Novartis Investigative Site — North Dartmouth, Massachusetts, United States
• Novartis Investigative Site — Livonia, Michigan, United States
• Novartis Investigative Site — Saint Charles, Missouri, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Lincoln, Nebraska, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Skillman, New Jersey, United States
• Novartis Investigative Site — Gastonia, North Carolina, United States
• Novartis Investigative Site — Monroe, North Carolina, United States
• Novartis Investigative Site — New Bern, North Carolina, United States
• Novartis Investigative Site — Raleigh, North Carolina, United States
• Novartis Investigative Site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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