Status:
COMPLETED
Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis
Conditions:
Pulmonary Disease, Chronic Obstructive
COPD
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of treatment with each o...
Eligibility Criteria
Inclusion
- Male and females aged 40-75 years with COPD and symptoms such as cough, sputum production, and shortness of breath.
- Smoking history of at least 10 pack years
- FEV1 less than 65% of the predicted normal value and at least 0.75 L
- Pre-bronchodilator FEV1/FVC less than 70%
Exclusion
- A history of asthma or COPD diagnosis before the age of 40
- Hospitalization for COPD exacerbation within the previous 6 weeks
- Respiratory tract infection within 6 weeks
- Use of long-term oxygen therapy
- Diabetes type I or uncontrolled diabetes type II
- Clinically relevant laboratory abnormality or clinically significant condition
- Corrected QT interval (QTc) above 430 ms for males and 450 ms for females, or a history of QTc prolongation. Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00396604
Start Date
October 1 2006
End Date
January 1 2007
Last Update
October 25 2011
Active Locations (1)
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1
Novartis
Vilvoorde, Belgium