Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks

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

NCT01068600

Run by

Novartis

People needed

318

Starts

2010-01-01

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 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 COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for 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 comorbid conditions
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Jasper, Alabama, United States
• Novartis Investigator Site — Glendale, Arizona, United States
• Novartis Investigator Site — Phoenix, Arizona, United States
• Novartis Investigator Site — Fullerton, California, United States
• Novartis Investigator Site — Los Angeles, California, United States
• Novartis Investigator Site — Los Angeles, California, United States
• Novartis Investigator Site — Riverside, California, United States
• Novartis Investigative Site — Clearwater, Florida, United States
• Novartis Investigative Site — Clearwater, Florida, United States
• Novartis Investigative Site — Hollywood, Florida, United States
• Novartis Investigative site — Miami, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Winter Park, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigator Site — Normal, Illinois, United States
• Novartis Investigator Site — Iowa City, Iowa, United States
• Novartis Investigative Site — Madisonville, Kentucky, United States
• Novartis Investigator Site — Baton Rouge, Louisiana, United States
• Novartis Investigator Site — Opelousas, Louisiana, United States
• Novartis Investigator Site — Saint Charles, Missouri, United States
• Novartis Investigator Site — St Louis, Missouri, United States
• Novartis Investigator Site — Lincoln, Nebraska, United States
• Novartis Investigator Site — Omaha, Nebraska, United States
• Novartis Investigator Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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