Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Low Dietary Salicylate on Biochemical Markers of Aspirin Exacerbated Respiratory Disease

Conditions
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Chronic Rhinosinusitis, Aspirin Exacerbated Respiratory Disease, Asthma, Aspirin Sensitivity

Intervention / Treatment
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* Behavioral: Low salicylate diet
* Behavioral: Normal Diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low salicylate diet, then Normal Diet<br>Patients followed a low salicylate diet for one week, then they followed a Normal diet for another week. | Behavioral: Low salicylate diet<br>* Participants followed a 7 days period under a Low salicylate diet<br>* Other names: Dietary salicylate;|
| Experimental: Normal diet, then Low Salicylate diet<br>Patients followed a Normal diet for one week, then they followed a Low Salicylate diet for another week. | Behavioral: Normal Diet<br>* Participants followed a 7 days period under a Normal Diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sino-Nasal Outcome Test (SNOT-22) | 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) | 14 days after commencement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Chronic Rhinosinusitis, Aspirin exacerbated respiratory disease, Aspirin sensitivity, Salicylate