Status:
COMPLETED
Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
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).
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- • 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.
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT00624286
Start Date
February 1 2008
End Date
July 1 2008
Last Update
August 18 2011
Active Locations (120)
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1
Novartis Investigative Site
Anniston, Alabama, United States, 36207-5710
2
Novartis Investigative Site
Birmingham, Alabama, United States, 35209-6870
3
Novartis Investigative Site
Jasper, Alabama, United States, 35501
4
Novartis Investigative Site
Mobile, Alabama, United States, 36608-6705