Status:
COMPLETED
Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide ...
Eligibility Criteria
Inclusion
- Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).
Exclusion
- Patients with significant diseases other than COPD that may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study, with a history of asthma or allergic rhinitis, who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy or using oral corticosteroid me dication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day will be excluded.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1480 Patients enrolled
Trial Details
Trial ID
NCT00400153
Start Date
November 1 2006
Last Update
June 13 2014
Active Locations (180)
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1
1012.56.01006 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
1012.56.01051 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States
3
1012.56.01071 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
4
1012.56.01039 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States