Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	January 29, 2013
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; Asthma; Aspirin sensitivity; Salicylate

Additional relevant MeSH terms:

Respiration Disorders; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity; Aspirin; Salicylates; Salicylic Acid; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; 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; Antipyretics; Anti-Infective Agents; Antifungal Agents; Keratolytic Agents; Dermatologic Agents