A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

Key facts

Study ID

NCT01005901

Run by

Novartis

People needed

1324

Starts

2009-10-01

Expected to finish

2010-12-01

Last updated by the study team

2012-04-12

Who can join

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

You may qualify if…

• Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:
• Smoking history of at least 10 pack-years
• Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value
• Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

You may not qualify if…

• Patients who have had a lower respiratory tract infection within 6 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 comorbid 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 tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Fairhope, Alabama, United States
• Novartis Investigative Site — Glendale, Arizona, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Walnut Creek, California, United States
• Novartis Investigative Site — Newark, Delaware, United States
• Novartis Investigative Site — Port Orange, Florida, United States
• Novartis Investigative Site — Tamarac, Florida, United States
• Novartis Investigative Site — Topeka, Kansas, United States
• Novartis Investigative Site — Madisonville, Kentucky, United States
• Novartis Investigative Site — Slidell, Louisiana, United States
• Novartis Investigative Site — Biddeford, Maine, United States
• Novartis Investigative Site — Pikesville, Maryland, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Livonia, Michigan, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Kansas City, Missouri, United States
• Novartis Investigative Site — Saint Charles, Missouri, United States
• Novartis Investigative Site — Missoula, Montana, United States
• Novartis Investigative Site — Bellevue, Nebraska, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Reno, Nevada, United States
• Novartis Investigative Site — New Brunswick, New Jersey, United States
• Novartis Investigative Site — Rochester, New York, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Birmingham, Alabama, 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.