12-week Efficacy of Indacaterol

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.

Key facts

Study ID

NCT01072448

Run by

Novartis

People needed

323

Starts

2010-01-01

Expected to finish

2010-07-01

Last updated by the study team

2011-08-19

Who can join

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

You may qualify if…

• Diagnosis of chronic obstructive pulmonary disease (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 forced expiratory volume in 1 second (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 COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
• Patients who have had a respiratory tract infection within 6 weeks prior to screening
• Patients with concomitant pulmonary disease
• Patients with a history of asthma
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Any patient with lung cancer or a history of lung cancer
• Patients with a history of certain cardiovascular co-morbid conditions Other protocol-defined inclusion/exclusion criteria applied to the study.

Where it is running

• Novartis Investigator Site — Pine Bluff, Arkansas, United States
• Novartis Investigator Site — Buena Park, California, United States
• Novartis Investigator Site — Encinitas, California, United States
• Novartis Investigator Site — Fountain Valley, California, United States
• Novartis Investigator Site — Los Angeles, California, United States
• Novartis Investigator Site — San Diego, California, United States
• Novartis Investigator Site — San Diego, California, United States
• Novartis Investigator Site — Temecula, California, United States
• Novartis Investigator Site — Torrance, California, United States
• Novartis Investigator Site — Walnut Creek, California, United States
• Novartis Investigator Site — Wheat Ridge, Colorado, United States
• Novartis Investigative Site — Port Orange, Florida, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — Tamarac, Florida, United States
• Novartis Investigator Site — Couer D'Alene, Idaho, United States
• Novartis Investigator Site — Champaign, Illinois, United States
• Novartis Investigator Site — Downers Grove, Illinois, United States
• Novartis Investigative Site — River Forest, Illinois, United States
• Novartis Investigator Site — Skokie, Illinois, United States
• Novartis Investigator Site — Springfield, Illinois, United States
• Novartis Investigative site — Lexington, Kentucky, United States
• Novartis Investigator Site — Covington, Louisiana, United States
• Novartis Investigator Site — Metaire, Louisiana, United States
• Novartis Investigative Site — Bangor, Maine, United States
• Novartis Investigator Site — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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