Status:
COMPLETED
A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.
Eligibility Criteria
Inclusion
- \- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
- a) Smoking history of at least 10 pack-years
- b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
- c) Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%
Exclusion
- Patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a COPD exacerbation 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 applied to the study.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
1598 Patients enrolled
Trial Details
Trial ID
NCT00900731
Start Date
June 1 2009
End Date
March 1 2010
Last Update
August 19 2011
Active Locations (212)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Birmingham, Alabama, United States, 35209
2
Novartis Investigator Site
Jasper, Alabama, United States, 35501
3
Novartis Investigative Site
Phoenix, Arizona, United States, 85050
4
Novartis Investigative Site
Tucson, Arizona, United States, 85723