Status:
COMPLETED
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
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 obs...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
1134 Patients enrolled
Trial Details
Trial ID
NCT00846586
Start Date
March 1 2009
End Date
March 1 2010
Last Update
August 18 2011
Active Locations (137)
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1
Novartis Investigator Site
Birmingham, Alabama, United States, 32509
2
Novartis Investigator Site
Mobile, Alabama, United States, 36608
3
Novartis Investigative Site
Scottsdale, Arizona, United States, 85258
4
Novartis Investigative Site
Tucson, Arizona, United States, 85712