Status:
COMPLETED
Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
To evaluate acute effect of single dose of ipratropium (Atrovent) or fenoterol (Berotec) in comparison to placebo when given to COPD patients on pharmacodynamic steady state of tiotropium (Spiriva)
Detailed Description
In case mono-bronchodilator therapy does not control symptoms of COPD adequately or if regular maintenance therapy is desired, a therapeutic intervention with a combination of bronchodilators is recom...
Eligibility Criteria
Inclusion
- Inclusion:
- diagnosis of COPD
- FEV1 \< 60% of predicted
- FEV1 \< 70% of FVC
- smoking history of 10 pack-years
- Exclusion:
- significant other disease than COPD
- history of asthma, allergic rhinitis or blood eosinophil count \> 600mm3
- cardiac arrhythmia requiring drug therapy
- symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
- recent history of MI (within past year)
- history of cancer within past 5 years
- life-threatening pulmonary obstruction
- cystic fibrosis or bronchiectasis; tuberculosis
- pulmonary resection
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2003
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00274066
Start Date
October 1 2002
End Date
September 1 2003
Last Update
November 1 2013
Active Locations (5)
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1
Twenteborg Ziekenhuis
Almelo, Netherlands, 7609 PP
2
Amphia Ziekenhuis
Breda, Netherlands, 4819 EV
3
Boehringer Ingelheim Investigational Site
Groningen, Netherlands, 9700 RB
4
Afdeling longziekten
Winschoten, Netherlands, 9670 RA