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Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

Primary Purpose

Chronic Rhinosinusitis, Aspirin Exacerbated Respiratory Disease, Asthma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Low salicylate diet
Normal Diet
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis focused on measuring Chronic Rhinosinusitis, Aspirin exacerbated respiratory disease, Asthma, Aspirin sensitivity, Salicylate

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Joseph's Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low salicylate diet, then Normal Diet

Normal diet, then Low Salicylate diet

Arm Description

Patients followed a low salicylate diet for one week, then they followed a Normal diet for another week.

Patients followed a Normal diet for one week, then they followed a Low Salicylate diet for another week.

Outcomes

Primary Outcome Measures

Urinary Levels of Cys-Leukotrienes
Urinary Salicyluric Acid Levels
Urinary Salicylic Acid Levels
Urinary Creatinine Levels

Secondary Outcome Measures

Sino-Nasal Outcome Test (SNOT-22)
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)

Full Information

First Posted
January 26, 2013
Last Updated
February 17, 2021
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01778465
Brief Title
Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease
Official Title
Effect of Low Dietary Salicylate on Biochemical Markers of Aspirin Exacerbated Respiratory Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis, Aspirin Exacerbated Respiratory Disease, Asthma, Aspirin Sensitivity
Keywords
Chronic Rhinosinusitis, Aspirin exacerbated respiratory disease, Asthma, Aspirin sensitivity, Salicylate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low salicylate diet, then Normal Diet
Arm Type
Experimental
Arm Description
Patients followed a low salicylate diet for one week, then they followed a Normal diet for another week.
Arm Title
Normal diet, then Low Salicylate diet
Arm Type
Experimental
Arm Description
Patients followed a Normal diet for one week, then they followed a Low Salicylate diet for another week.
Intervention Type
Behavioral
Intervention Name(s)
Low salicylate diet
Other Intervention Name(s)
Dietary salicylate
Intervention Description
Participants followed a 7 days period under a Low salicylate diet
Intervention Type
Behavioral
Intervention Name(s)
Normal Diet
Intervention Description
Participants followed a 7 days period under a Normal Diet
Primary Outcome Measure Information:
Title
Urinary Levels of Cys-Leukotrienes
Time Frame
14 days after commencement
Title
Urinary Salicyluric Acid Levels
Time Frame
14 days after commencement
Title
Urinary Salicylic Acid Levels
Time Frame
14 days after enrollment
Title
Urinary Creatinine Levels
Time Frame
14 days after commencement
Secondary Outcome Measure Information:
Title
Sino-Nasal Outcome Test (SNOT-22)
Description
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)
Time Frame
14 days after commencement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh J Sowerby, MD
Organizational Affiliation
Lawson HRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N5A 4V2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33892819
Citation
Sowerby LJ, Patel KB, Schmerk C, Rotenberg BW, Rocha T, Sommer DD. Effect of low salicylate diet on clinical and inflammatory markers in patients with aspirin exacerbated respiratory disease - a randomized crossover trial. J Otolaryngol Head Neck Surg. 2021 Apr 23;50(1):27. doi: 10.1186/s40463-021-00502-4.
Results Reference
derived

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Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

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