N/A N=7 Randomized Treatment

Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

Chronic Rhinosinusitis · Aspirin Exacerbated Respiratory Disease · Asthma · Aspirin Sensitivity

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View on ClinicalTrials.gov: NCT01778465 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Urinary Levels of Cys-Leukotrienes — 874.05; 771.99 pg/ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Low salicylate diet (Behavioral); Normal Diet (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Urinary Levels of Cys-Leukotrienes	874.05; 771.99	—
PRIMARY Urinary Salicyluric Acid Levels	44.21; 23.82	—
PRIMARY Urinary Salicylic Acid Levels	0.6; 0.92	—
PRIMARY Urinary Creatinine Levels	9.9; 15.3	—
SECONDARY Sino-Nasal Outcome Test (SNOT-22)	44; 66	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

adult patients
Aspirin-exacerbated respiratory disease

Exclusion Criteria

recent use of Prednisone or other systemic steroids (greater than 3 doses in past 3 months)
Endoscopic sinus surgery or polypectomy within the past 6 months
Other significant systemic disease, including renal failure, or immunocompromised state.

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Data sourced from ClinicalTrials.gov (NCT01778465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.