Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)

Key facts

Study ID

NCT00846586

Run by

Novartis Pharmaceuticals

People needed

1134

Starts

2009-03-01

Expected to finish

2010-03-01

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…

• Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) and:
• Smoking history of at least 10 pack-years
• Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
• Post-bronchodilator FEV1/FVC (force vital capacity) < 70%

You may not qualify if…

• Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening or during the run-in period
• Patients who have had a respiratory tract infection within 6 weeks prior to screening or during the run-in period
• Patients with a body mass index less than 15 or more than 40 kg/m\^2
• 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 applied to the study.

Where it is running

• Novartis Investigator Site — Mobile, Alabama, United States
• Novartis Investigative Site — Scottsdale, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigator Site — Pine Bluff, Arkansas, United States
• Novartis Investigator Site — Fountain Valley, California, United States
• Novartis Investigator Site — Long Beach, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigator Site — National City, California, United States
• Novartis Investigator Site — Palmdale, California, United States
• Novartis Investigative Site — Stockton, California, United States
• Novartis Investigator Site — Temecula, California, United States
• Novartis Investigative Site — Hartford, Connecticut, United States
• Novartis Investigative Site — Clearwater, Florida, United States
• Novartis Investigator Site — Fort Walton Beach, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Naranja, Florida, United States
• Novartis Investigator Site — Pensacola, Florida, United States
• Novartis Investigator Site — Sarasota, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigator Site — Conyers, Georgia, United States
• Novartis Investigative Site — Normal, Illinois, United States
• Novartis Investigative Site — Iowa City, Iowa, United States
• Novartis Investigator Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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