A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.

Key facts

Study ID

NCT01202188

Run by

Novartis Pharmaceuticals

People needed

2144

Starts

2010-09-01

Expected to finish

2012-03-01

Last updated by the study team

2013-09-09

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 COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
• Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

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 — Riverside, California, United States
• Novartis Investigative Site — St. Petersburg, Florida, United States
• Novartis Investigative Site — Troy, Michigan, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Saint Charles, Missouri, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Columbus, Ohio, United States
• Novartis Investigative Site — Medford, Oregon, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Greenville, South Carolina, United States
• Novartis Investigative Site — Johnson City, Tennessee, United States
• Novartis Investigative Site — Daw Park, Australia
• Novartis Investigative Site — Glebe, Australia
• Novartis Investigative Site — Kogarah, Australia
• Novartis Investigative Site — Nedlands, Australia
• Novartis Investigative site — New Lambton, Australia
• Novartis Investigative Site — Pleven, Bulgaria
• Novartis Investigative Site — Rousse, Bulgaria
• Novartis Investigative Site — Sofia, Bulgaria
• Novartis Investigative Site — Stara Zagora, Bulgaria
• Novartis Investigative Site — Varna, Bulgaria
• Novartis Investigative Site — Vancouver, British Columbia, Canada
• Novartis Investigative Site — Fullerton, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.