A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

This study was conducted to provide detailed information on the efficacy of indacaterol in terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a 24 hour time period.

Key facts

Study ID

NCT00622635

Run by

Novartis Pharmaceuticals

People needed

68

Starts

2008-01-01

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…

• Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2006) and:
• Smoking history of at least 20 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 been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
• Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia
• 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
• Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time
• Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged
• Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
• 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 Investigator Site — Normal, Illinois, United States
• Novartis Investigator Site — Shawnee Mission, Kansas, United States
• Novartis Investigator Site — Lafayette, Louisiana, United States
• Novartis Investigator Site — Charlotte, North Carolina, United States
• Novartis Investigator Site — Raleigh, North Carolina, United States
• Novartis Investigator site — Cincinnati, Ohio, United States
• Novartis Investigator Site — Spartanburg, South Carolina, United States
• Novartis Investigator Site — Genk, Belgium
• Novartis Investigator Site — Hasselt, Belgium
• Novartis Investigator Site — Herentals, Belgium
• Novartis Investigator Site — Alicante, Spain
• Novartis Investigator site — Alzira, Spain
• Novartis Investigator Site — Madrid, Spain
• Novartis Investigator site — Mataró, Spain

Full record on ClinicalTrials.gov

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