Status:
COMPLETED
Effect of Brovana and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Trinity Health Of New England
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
COPD
Eligibility:
All Genders
40-90 years
Phase:
PHASE4
Brief Summary
This will be a double-blind crossover trial in 20 patient with stable COPD. Data from this study will provide proof-of-concept information on whether the (anticipated) additional bronchodilator effect...
Detailed Description
Hypotheses to be tested: Brovana nebulized twice daily added to maintenance inhaled tiotropium therapy in stable COPD patients increases: 1. Forced expiratory volume in 1 second (FEV1) at peak dose ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Informed consent (Approval by the St. Francis Hospital Institutional Review Board (IRB) will be required before study initiation)
- Adults, age \> 40 years
- A clinical diagnosis of COPD, with spirometric confirmation: post-bronchodilator forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC) ( \< 0.70
- Moderate, severe and very severe airflow limitation by GOLD criteria.
- Clinically stable respiratory disease
- The perceived ability to participate in pulmonary testing and exercise testing
- COPD, stable state
- Exclusion criteria:
- Women of childbearing potential
- Asthma
- Supplemental oxygen use or anticipated oxygen desaturation \< 85% at peak exercise (patients who desaturate below 85% on the incremental study will be excluded)
- Co-morbidity that would interfere with the patient participating in the study, including the exercise testing. Examples include unstable cardiac disease, arthritis, psychological problems that would interfere with participation
- An exacerbation requiring therapy or any change in maintenance COPD therapy within six weeks of testing
- A history of a prolonged QT interval
- Recent exacerbation of COPD
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00773786
Start Date
October 1 2008
End Date
May 1 2009
Last Update
August 6 2019
Active Locations (1)
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1
St Francis Hospital and Medical center
Hartford, Connecticut, United States, 06105