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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 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 Asthma Aspirin Sensitivity Behavioral: Low salicylate diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 Leigh Sowerby, Lawson Health Research Institute:

Primary Outcome Measures:
  • Urinary levels of Cys-Leukotrienes [ Time Frame: 14 days after commencement ]

Secondary Outcome Measures:
  • Urinary salicylate levels [ Time Frame: 14 days after enrollment ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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 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 Identifier: NCT01778465     History of Changes
Other Study ID Numbers: 103330
Study First Received: January 26, 2013
Last Updated: March 1, 2015

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

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Immune System Diseases
Salicylic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents processed this record on September 21, 2017