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 is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indaca...
Eligibility Criteria
Inclusion
- 1\. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) and:
- Smoking history of at least 20 pack-years
- Post-bronchodilator 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 Visit 1 or during the run-in period
- Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
- 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
- Patients who have been exposed to indacaterol previously. (Except for any patient who enrolled in Study CQAB149B1302)
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00876694
Start Date
March 1 2009
End Date
October 1 2010
Last Update
November 8 2011
Active Locations (37)
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1
Novartis Investigator Site
Asahikawa, Japan
2
Novartis Investigator Site
Bunkyō City, Japan
3
Novartis Investigator Site
Gifu, Japan
4
Novartis Investigator Site
Hamamatsu, Japan