Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

Not Applicable

Completed

• Conditions: Chronic Rhinosinusitis; Aspirin Exacerbated Respiratory Disease; Asthma; Aspirin Sensitivity
• Interventions: Behavioral: Low salicylate diet; Behavioral: Normal Diet

• Registration Number: NCT01778465
• Lead Sponsor: Lawson Health Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-26
• Study First Submitted QC: 2013-01-26
• Study First Posted: 2013-01-29
• Study Start: 2013-05
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Status Verified: 2015-03
• Results First Submitted: 2020-07-15
• Results First Submitted QC: 2021-02-17
• Last Update Submitted: 2021-02-17
• Results First Posted: 2021-03-09
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low salicylate diet, then Normal Diet	Low salicylate diet	Patients followed a low salicylate diet for one week, then they followed a Normal diet for another week.
Normal diet, then Low Salicylate diet	Normal Diet	Patients followed a Normal diet for one week, then they followed a Low Salicylate diet for another week.

Primary Outcome Measures

Name	Time	Method
Urinary Levels of Cys-Leukotrienes	14 days after commencement
Urinary Salicyluric Acid Levels	14 days after commencement
Urinary Salicylic Acid Levels	14 days after enrollment
Urinary Creatinine Levels	14 days after commencement

Secondary Outcome Measures

Name	Time	Method
Sino-Nasal Outcome Test (SNOT-22)	14 days after commencement	The Sino-Nasal Outcome Test (SNOT-22) is a validated 22-item Chronic rhinosinusitis-specific instrument which is scored using a scale where 0="No problem", 1="Very mild problem", 2="Mild or slight problem", 3="Moderate problem", 4="Severe problem", and 5="Problem as bad as it can be". Higher scores on the SNOT-22 survey items suggest worse patient functioning or symptom severity (total score range: 0-110)

Trial Locations

Locations (1)

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada