Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00691951
- Lead Sponsor
- Laval University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparative changes before and after treatments in each group for Asthma Control Questionnaire (ACQ)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Hôpital du Sacré-Coeur de Montreal
🇨🇦Montréal, Quebec, Canada
Laval Hospital
🇨🇦Quebec, Canada