Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

• Sponsor: Lawson Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01778465
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Rhinosinusitis; Aspirin Exacerbated Respiratory Disease; Asthma; Aspirin Sensitivity	Behavioral: Low salicylate diet; Behavioral: Normal Diet	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 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 1, 2013
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Urinary Levels of Cys-Leukotrienes [14 days after commencement]

2. Urinary Salicyluric Acid Levels [14 days after commencement]

3. Urinary Salicylic Acid Levels [14 days after enrollment]

4. Urinary Creatinine Levels [14 days after commencement]

Secondary Outcome Measures

1. Sino-Nasal Outcome Test (SNOT-22) [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT01778465
• Other Study ID Numbers: 103330
• First Posted: Jan 29, 2013
• Last Update Posted: Mar 9, 2021
• Last Verified: Mar 1, 2015

• 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; Hypersensitivity; Salicylic Acid; Salicylates

Study Results

Participant Flow

Arm/Group Title	Low Salicylate Diet, Then Normal Diet	Normal Diet, Then Low Salicylate Diet
Arm/Group Description	Participants followed a low salicylate diet for 7 days, then they started a period of 7 days on Normal diet.	Participants followed a normal diet for 7 days, then they started a period of 7 days on Low Salicylate Diet
Period Title: First Intervention (7 Days)
STARTED	3	4
COMPLETED	3	4
NOT COMPLETED	0	0
Period Title: First Intervention (7 Days)
STARTED	3	4
COMPLETED	3	4
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	Participants followed a low salicylate diet for one week. Then, participants continued with a normal diet for one week.
Overall Participants	7
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55 (13.1)
Sex: Female, Male (Count of Participants)
Female	2 28.6%
Male	5 71.4%

Outcome Measures

1. Primary Outcome

Title	Urinary Levels of Cys-Leukotrienes
Time Frame	14 days after commencement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Salicylate Diet	Normal Diet
Arm/Group Description	Patients followed a low salicylate diet for one week	Patients followed a Normal diet for one week.
Measure Participants	7	7
Median (Inter-Quartile Range) [pg/ml]	874.05	771.99

2. Primary Outcome

Title	Urinary Salicyluric Acid Levels
Time Frame	14 days after commencement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Salicylate Diet	Normal Diet
Arm/Group Description	Patients followed a low salicylate diet for one week	Participants followed a normal diet for 7 days
Measure Participants	7	7
Median (Inter-Quartile Range) [ng/ml]	44.21	23.82

3. Primary Outcome

Title	Urinary Salicylic Acid Levels
Time Frame	14 days after enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Salicylate Diet	Normal Diet
Arm/Group Description	Participants followed a low salicylate diet for 7 days	Participants followed a normal diet for 7 days
Measure Participants	7	7
Median (Inter-Quartile Range) [ng/ml]	0.6	0.92

4. Primary Outcome

Title	Urinary Creatinine Levels
Time Frame	14 days after commencement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Salicylate Diet	Normal Diet
Arm/Group Description	Participants followed a low salicylate diet for 7 days	Participants followed a normal diet for 7 days
Measure Participants	7	7
Median (Inter-Quartile Range) [mmol/L]	9.9	15.3

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Salicylate Diet	Normal Diet
Arm/Group Description	Patients followed a low salicylate diet for one week.	Patients followed a Normal diet for one week.
Measure Participants	7	7
Median (Inter-Quartile Range) [score on a scale]	44	66

Adverse Events

Arm/Group Title	Low Salicylate Diet		Normal Diet
Arm/Group Description	Participants followed a low salicylate diet for 7 days		Participants followed a normal diet for 7 days
All Cause Mortality
	Low Salicylate Diet		Normal Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)
Serious Adverse Events
	Low Salicylate Diet		Normal Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Low Salicylate Diet		Normal Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.