Status:
COMPLETED
An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD)
Lead Sponsor:
Novartis
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients
Eligibility Criteria
Inclusion
- Male and female subjects,
- 40 to 80 years of age,
- with a documented diagnosis of mild, moderate or severe chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and \>20-pack year history of smoking, a post-bronchodilator 40% ≤ FEV1 ≤ 80% of predicted normal and post-bronchodilator FEV1/FVC \< 70% who have signed an informed consent form (ICF) prior to the initiation of any study-related procedure (Post bronchodilator refers to 30 minutes after the inhalation of 400 µg of salbutamol)
- Subjects who demonstrate a plethysmographic functional residual capacity \>120% predicted normal
Exclusion
- No COPD exacerbations within 6 weeks prior to dosing,
- no concomitant lung disease such as asthma,
- no requirement for long term oxygen treatment or history of lung reduction surgery.
- No medical conditions that would interfere with the performance of spirometry or clinical exercise testing.
- 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 participating in the study e.g. uncontrolled hypertension or unstable ischemic heart disease
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00636961
Start Date
February 1 2008
End Date
August 1 2008
Last Update
August 30 2011
Active Locations (3)
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1
Novartis Investigator Site
Berlin, Germany
2
Novartis Investigator Site
Mönchengladbach, Germany
3
Novartis Investigator Site
Wiesbaden, Germany