Status:
COMPLETED
Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide
Lead Sponsor:
University of Miami
Collaborating Sponsors:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Glucocorticosteroids recently have been shown to have non-genomic actions that are plasma membrane-mediated and do not require gene transcription and translation. One of these non-genomic effects is t...
Detailed Description
Inhaled glucocorticosteroids typically are not recommended for the treatment of acute asthma attacks. This practice is based on the fact that glucocorticosteroids by themselves do not cause rapid bron...
Eligibility Criteria
Inclusion
- Twenty lifetime nonsmokers moderate or severe asthmatics; FEV1≥50 of predicted on the screening day
Exclusion
- Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women; Cardiovascular disease and/or use of cardiovascular medication; Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance; Acute respiratory infection and or acute exacerbation of asthma within four weeks prior to the study; Use of systemic glucocorticosteroids within 4 weeks prior to the study; Daily ICS dose (fluticasone or budesonide) \> 500ug; Diabetes mellitus
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01219738
Start Date
July 1 2008
End Date
August 1 2012
Last Update
January 16 2015
Active Locations (1)
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1
Pulmonary Human Research Laboratory, University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136