Asthma/Steroid Withdrawal Study
Recruitment status was Active, not recruiting
The investigators propose to study the patterns of metabolite changes in subjects with asthma to determine if there is a predictable pattern prior to, and post, clinical exacerbation.
Hypothesis: 1. Metabolite profiles will change prior to detection of a clinical exacerbation in subjects with asthma.
2. There will be a measurable temporal delay before metabolite profiles return to baseline following anti-inflammatory therapy of an exacerbation of asthma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Temporal Sequence of Inflammatory Mediators During a Controlled Exacerbation of Asthma by Steroid Withdrawal.|
- Metabolite changes in induced sputum [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Metabolite changes in urine [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Health related quality of life status [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Peak expiratory flow measurements [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||October 2010|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Drug: inhaled corticosteroid
Fluticasone; Budesonide; Ciclesonide Dosage and frequency is patient dependant.
Other Name: Flovent; Pulmicort; Alvesco.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00395239
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G 2B7|
|Principal Investigator:||Irvin Mayers, MD, FRCPC||University of Alberta|