Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects
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...
Brief Summary
Official Title: “Comparative Effects of Budesonide and Budesonide/Formoterol (Symbicort) on Asthma Control in Smoking Asthmatic Subjects: A Pilot Study”
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
Outcome Measures for this Clinical Trial
Primary Measures
- Comparative changes before and after treatments in each group for Asthma Control Questionnaire (ACQ)
Secondary Measures
- 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
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 Investigator Information
Lead Investigator: Laval University Other
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00691951
