Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects
D5890L00013
Comparative Effects of Budesonide and Budesonide/Formoterol (Symbicort) on Asthma Control in Smoking Asthmatic Subjects: A Pilot Study
1 other identifier
interventional
N/A
1 country
2
Brief Summary
A reduced response to inhaled corticosteroids (ICS) has been reported in smoking compared to non-smoking asthmatic patients. However, the comparative response to other currently prescribed medications such as combination therapy of long-acting beta agonists and ICS remain to be further evaluated. No significant differences were found between our group of subjects in regard to changes in asthma control pulmonary function and airway inflammation following budesonide or the association of budesonide with formoterol for a period of 2 months. This should be further explored in larger groups of subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedOctober 21, 2008
June 1, 2008
June 4, 2008
October 17, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Comparative changes before and after treatments in each group for Asthma Control Questionnaire (ACQ)
Secondary Outcomes (5)
Other control scores (ACSS score) and rescue B2 agonist need
Comparative changes in FEV1
Quality of life questionnaire
Morning and evening PEF
Total and differential cell counts in induced sputum and ECP and MPO
Interventions
Eligibility Criteria
You may qualify if:
- Asthmatic non-smokers or ex-smokers (less than 10 pack/years)
- Asthmatic smokers (more than 5 cigarettes a day and more than 5 pack/years
- FEV1 greater than 70%
- No more than 3 doses of rescue medication (bronchodilator) per day
You may not qualify if:
- Mentally or legally incapacitated thus preventing informed consent from being obtained
- Other pulmonary disorder
- History of upper respiratory tract infection in the last month
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
- AstraZenecacollaborator
Study Sites (2)
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
Laval Hospital
Québec, Quebec, G1V 4G5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 4, 2008
First Posted
June 6, 2008
Last Updated
October 21, 2008
Record last verified: 2008-06