Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).

Key facts

Study ID

NCT00624286

Run by

Novartis

People needed

416

Starts

2008-02-01

Expected to finish

2008-07-01

Last updated by the study team

2011-08-18

Who can join

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

You may qualify if…

• Male or female patients aged 40 years or over with moderate to severe chronic obstructive pulmonary disease (COPD) plus
• 20 pack-year smoking history
• Signed informed consent
• Post-bronchodilator forced expiratory volume in 1 second )FEV1) ≥ 30% and < 80% predicted FEV1/FVC (forced vital capacity) < 70%
• Exclusion Criteria include:
• History of asthma
• Prior exposure to indacaterol
• Active cancer or history of cancer
• Patients with concomitant pulmonary disease
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged
• Patients unable to successfully use a dry-powder inhaler device or perform spirometry measurements
• Other protocol-defined inclusion/exclusion criteria applied to the study.

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Jasper, Alabama, United States
• Novartis Investigative Site — Mobile, Alabama, United States
• Novartis Investigator Site — Glendale, Arizona, United States
• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Pine Bluff, Arkansas, United States
• Novartis Investigative Site — Buena Park, California, United States
• Novartis Investigative Site — Encinitas, California, United States
• Novartis Investigative Site — Fresno, California, United States
• Novartis Investigative Site — Fullerton, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Orange, California, United States
• Novartis Investigative Site — Palmdale, California, United States
• Novartis Investigative Site — Riverside, California, United States
• Novartis Investigative Site — San Jose, California, United States
• Novartis Investigative Site — San Mateo, California, United States
• Novartis Investigative Site — Stockton, California, United States
• Novartis Investigative Site — Torrance, California, United States
• Novartis Investigative Site — Vista, California, United States
• Novartis Investigative Site — Walnut Creek, California, United States
• Novartis Investigative Site — Fort Collins, Colorado, United States
• Novartis Investigative Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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