Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease
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|ClinicalTrials.gov Identifier: NCT01778465|
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : March 3, 2015
Aspirin-Exacerbated Respiratory Disease, or AERD, consists of aspirin sensitivity, asthma and nasal polyps. It is currently managed by chronic steroid use, multiple endoscopic sinus surgeries and/or aspirin desensitization. However, these treatments have potential adverse effects.
A theory has been postulated that decreasing the level of dietary salicylates may help in long-term control of disease. A current trial is in the works to evaluate the clinical outcomes of decreased salicylate, but measurements of biochemical markers of disease has not yet been done. The hypothesis is that decreased dietary salicylates will result in a decrease in urinary salicylates and inflammatory markers of disease, cys-leukotrienes, which are typically elevated in this disease.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinosinusitis Aspirin Exacerbated Respiratory Disease Asthma Aspirin Sensitivity||Behavioral: Low salicylate diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Low Dietary Salicylate on Biochemical Markers of Aspirin Exacerbated Respiratory Disease|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||May 2014|
Experimental: Low salicylate diet
Patients are to follow a low salicylate diet for one week.
Behavioral: Low salicylate diet
Other Name: Dietary salicylate
No Intervention: Normal diet
Patients are to continue with a normal diet for one week. There is then cross-over after one week for a further week into the intervention group.
- Urinary levels of Cys-Leukotrienes [ Time Frame: 14 days after commencement ]
- Urinary salicylate levels [ Time Frame: 14 days after enrollment ]
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): NCT01778465
|St. Joseph's Health Care|
|London, Ontario, Canada, N5A 4V2|
|Principal Investigator:||Leigh J Sowerby, MD||Lawson HRI|