Status:
COMPLETED
Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The ability for patients with COPD to exercise is limited due to the deterioration of their lung function. NVA237 is being developed to treat COPD. This study is designed to look at how well NVA237 im...
Eligibility Criteria
Inclusion
- Patients who signed an Informed Consent Form prior to initiation of any study-related procedure
- Patients with moderate to severe stable COPD (clinical diagnosis in compliance with GOLD 2008)
- Current or ex-smokers with a smoking history ≥ 10 pack years. (Ten pack-years were defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.).
- Patients with a post-bronchodilator FEV1 ≥ 40 and \< 70% of the predicted normal, and postbronchodilator FEV1/FVC \< 0.7 during screening. (Post referred to the highest post-bronchodilator value after inhalation of 80 μg ipratropium bromide)
- Increase in FEV1 from pre- to post-bronchodilator assessment of ≥ 5%
Exclusion
- Pregnant women or nursing mothers
- Women of child-bearing potential
- Patients who had a COPD exacerbation (whether hospitalized or not) in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 4
- Patients who had a lower respiratory tract infection in the 6 weeks prior to Visit 1
- Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia
- Patients with resting (5 min) oxygen SaO2 (or SpO2) saturation on room air of \< 85%
- Patients with a maximum workload (Wmax) value \< 20 W (as determined by the incremental cycle endurance test) at Visit 2.
- Patients whose exercise endurance time at sub-maximal workload was above 25 min at baseline
- Patients with a clinically significant abnormality on the screening or baseline ECG who in the judgment of the investigator would have been at potential risk if enrolled into the study
- Patients with a history of long QT syndrome or whose QTc was prolonged (\> 450 ms for males and \> 470 ms females) at screening (Fredericia's correction)
- Other protocol-defined inclusion/exclusion criteria applied
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01154127
Start Date
June 1 2010
End Date
February 1 2011
Last Update
May 7 2012
Active Locations (10)
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1
Spartanburg Medical Research, 485 Simuel Road
Spartanburg, South Carolina, United States, 29303
2
Novartis Investigative Site
Berlin, Germany
3
Novartis Investigative Site
Frankfurt, Germany
4
Novartis Investigative Site
Mainz, Germany