Status:
COMPLETED
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \[od\]) in patients with moderate to severe chronic obstructiv...
Eligibility Criteria
Inclusion
- Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 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%.
Exclusion
- Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the 14 day run-in period prior to randomization.
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT00794157
Start Date
November 1 2008
End Date
October 1 2009
Last Update
August 17 2011
Active Locations (60)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigator Site
Hong Kong, Hong Kong
2
Novartis Investigator Site
New Territories, Hong Kong
3
Novartis Investigative Site
Ahmedabad, India
4
Novartis Investigator Site
Bangalore, India