Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778465
• Other study ID #: 103330
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: March 2015
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aspirin Exacerbated Respiratory Disease
• Aspirin Sensitivity
• Asthma
• Chronic Rhinosinusitis
• Hypersensitivity
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Behavioral:
• Low salicylate diet
Participants followed a 7 days period under a Low salicylate diet
• Normal Diet
Participants followed a 7 days period under a Normal Diet

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Levels of Cys-Leukotrienes		14 days after commencement
Primary	Urinary Salicyluric Acid Levels		14 days after commencement
Primary	Urinary Salicylic Acid Levels		14 days after enrollment
Primary	Urinary Creatinine Levels		14 days after commencement
Secondary	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)	14 days after commencement