Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

February 17, 2021 updated by: Lawson Health Research Institute

Effect of Low Dietary Salicylate on Biochemical Markers of Aspirin Exacerbated Respiratory Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low salicylate diet, then Normal Diet
Patients followed a low salicylate diet for one week, then they followed a Normal diet for another week.
Behavioral: Low salicylate diet
Participants followed a 7 days period under a Low salicylate diet
Other Names:
  • Dietary salicylate
Experimental: Normal diet, then Low Salicylate diet
Patients followed a Normal diet for one week, then they followed a Low Salicylate diet for another week.
Behavioral: Normal Diet
Participants followed a 7 days period under a Normal Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary Levels of Cys-Leukotrienes
Time Frame: 14 days after commencement
14 days after commencement
Urinary Salicyluric Acid Levels
Time Frame: 14 days after commencement
14 days after commencement
Urinary Salicylic Acid Levels
Time Frame: 14 days after enrollment
14 days after enrollment
Urinary Creatinine Levels
Time Frame: 14 days after commencement
14 days after commencement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sino-Nasal Outcome Test (SNOT-22)
Time Frame: 14 days after commencement
The Sino-Nasal Outcome Test (SNOT-22) is a validated 22-item Chronic rhinosinusitis-specific instrument which is scored using a scale where 0="No problem", 1="Very mild problem", 2="Mild or slight problem", 3="Moderate problem", 4="Severe problem", and 5="Problem as bad as it can be". Higher scores on the SNOT-22 survey items suggest worse patient functioning or symptom severity (total score range: 0-110)
14 days after commencement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Leigh J Sowerby, MD, Lawson HRI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 26, 2013

First Submitted That Met QC Criteria

January 26, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103330

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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