Asthma/Steroid Withdrawal Study
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|ClinicalTrials.gov Identifier: NCT00395239|
Recruitment Status : Terminated (This project will resume upon the completion of other research committments.)
First Posted : November 2, 2006
Last Update Posted : May 26, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: inhaled corticosteroid||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Temporal Sequence of Inflammatory Mediators During a Controlled Exacerbation of Asthma by Steroid Withdrawal.|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Drug: inhaled corticosteroid
Fluticasone; Budesonide; Ciclesonide Dosage and frequency is patient dependant.
Other Name: Flovent; Pulmicort; Alvesco.
- Metabolite changes in induced sputum [ Time Frame: 20 weeks ]
- Metabolite changes in urine [ Time Frame: 20 weeks ]
- Health related quality of life status [ Time Frame: 20 weeks ]
- Peak expiratory flow measurements [ Time Frame: 20 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395239
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G 2B7|
|Principal Investigator:||Irvin Mayers, MD, FRCPC||University of Alberta|