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...
Date First Received: June 4, 2008
Last Updated: June 5, 2008
Verified by: Laval University, June 2008
Clinical Trial Phase: Phase 3 | Start Date:
Overall Status: Completed
Brief Summary
Official Title: “Comparative Effects of Budesonide and Budesonide/Formoterol (Symbicort) on Asthma Control in Smoking Asthmatic Subjects: A Pilot Study”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: N/A
Intervention(s) in this Clinical Trial
- Drug: budesonide and budesonide/formoterol
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Laval University
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00691951
Study ID Number: Symbicort smokers AZ
ClinicalTrials.gov Identifier: NCT00691951
Health Authority: Canada: Canadian Institutes of Health Research
Clinical Trials Authorship and Review
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