Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

This study has been completed.
Information provided by (Responsible Party):
Leigh Sowerby, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
First received: January 26, 2013
Last updated: March 1, 2015
Last verified: March 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 Intervention
Chronic Rhinosinusitis
Aspirin Exacerbated Respiratory Disease
Aspirin Sensitivity
Behavioral: Low salicylate diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Low Dietary Salicylate on Biochemical Markers of Aspirin Exacerbated Respiratory Disease

Resource links provided by NLM:

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Urinary levels of Cys-Leukotrienes [ Time Frame: 14 days after commencement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary salicylate levels [ Time Frame: 14 days after enrollment ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: May 2013
Study Completion Date: May 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01778465

Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N5A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Principal Investigator: Leigh J Sowerby, MD Lawson HRI
  More Information

Responsible Party: Leigh Sowerby, Assistant Professor, Otolaryngology, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01778465     History of Changes
Other Study ID Numbers: 103330 
Study First Received: January 26, 2013
Last Updated: March 1, 2015
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by Lawson Health Research Institute:
Chronic Rhinosinusitis
Aspirin exacerbated respiratory disease
Aspirin sensitivity

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Salicylic Acid
Analgesics, Non-Narcotic
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antifungal Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Dermatologic Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Keratolytic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents

ClinicalTrials.gov processed this record on May 26, 2016