Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01778465
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : March 3, 2015
Information provided by (Responsible Party):
Leigh Sowerby, 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.

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis Aspirin Exacerbated Respiratory Disease Asthma Aspirin Sensitivity Behavioral: Low salicylate diet Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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
Study Start Date : May 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
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.

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Leigh Sowerby, Assistant Professor, Otolaryngology, Lawson Health Research Institute Identifier: NCT01778465     History of Changes
Other Study ID Numbers: 103330
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: March 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