Status:
COMPLETED
Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control
Lead Sponsor:
Novartis
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstruct...
Eligibility Criteria
Inclusion
- Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 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 volume capacity) \< 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)
Exclusion
- Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
- Patients who 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 co-morbid conditions.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
1732 Patients enrolled
Trial Details
Trial ID
NCT00393458
Start Date
October 1 2006
End Date
July 1 2008
Last Update
August 18 2011
Active Locations (183)
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1
Novartis Investigator Site
Buenos Aires, Argentina
2
Novartis
Buenos Aires, Argentina
3
Novartis Investigator Site
Mendoza, Argentina
4
Novartis Investigator Site
San Miguel, Argentina