Status:
COMPLETED
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.
Eligibility Criteria
Inclusion
- Diagnosis of COPD
- FEV1 \< 60% predicted
- FEV1 \< 70% of FVC
- Smoking history of 10 pack-years
Exclusion
- Significant other disease than COPD
- Recent history of MI (1 year or less)
- Cardiac arrhythmia requiring drug therapy
- History of asthma, allergic rhinitis or eosinophil count \> 600 mm3
- Symptomatic prostatic hypertrophy or bladder neck obstruction
- Known narrow-angle glaucoma
- Abnormal baseline hematology, blood chemistry or urinalysis
- History of cancer within last 5 years
- Life-threatening pulmonary obstruction
- Cystic fibrosis or bronchiectasis
- Tuberculosis
- Pulmonary resection
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00281567
Start Date
August 1 2002
Last Update
November 1 2013
Active Locations (2)
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1
Boehringer Ingelheim Investigational Site
Study Chairs Or Principal Investigators, Belgium
2
Boehringer Ingelheim Investigational Site
Study Chairs Or Principal Investigators, Netherlands