Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Leigh Sowerby, Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT01778465

First received: January 26, 2013

Last updated: March 1, 2015

Last verified: March 2015

History of Changes

Purpose

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: 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:

MedlinePlus related topics: Asthma

Drug Information available for: Aspirin

U.S. FDA Resources

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.

Eligibility


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

Criteria

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.

Contacts and Locations

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

Locations


Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N5A 4V2

Sponsors and Collaborators

Lawson Health Research Institute

Investigators


Principal Investigator:	Leigh J Sowerby, MD	Lawson HRI

More Information

No publications provided


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 Asthma Aspirin sensitivity Salicylate

Additional relevant MeSH terms:


Respiration Disorders Respiratory Tract Diseases Salicylates Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antirheumatic Agents Central Nervous System Agents	Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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