Status:
COMPLETED
Effect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol
Lead Sponsor:
Novartis
Conditions:
COPD
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the change in inspiratory capacity and lung function in patients with chronic obstructive pulmonary disease when treated with indacaterol compared to placebo and...
Eligibility Criteria
Inclusion
- Male and post-menopausal female adults aged 40-80 years inclusive.
- Patients with a clinical diagnosis of COPD according to the Global Initiative for Chronic Lung Disease (GOLD) Guidelines (2005)
- Smoking history of at least 10 pack years (either smokers or ex-smokers).
- Able to perform reproducible spirometry maneuvers.
- Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
Exclusion
- COPD exacerbations within 6 weeks prior to dosing
- Concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.
- Medical conditions that would interfere with the performance of spirometry or may pose a potential hazard from performing spirometry.
- Any other medical condition that in the opinion of the Investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease.
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00422552
Start Date
September 1 2006
Last Update
June 22 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative site
Horsham, United Kingdom