Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

NCT ID: NCT01778465

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-05-31

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.

Conditions

Chronic Rhinosinusitis; Aspirin Exacerbated Respiratory Disease; Asthma; Aspirin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low salicylate diet, then Normal Diet

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

Group Type: EXPERIMENTAL

Low salicylate diet

Intervention Type: BEHAVIORAL

Participants followed a 7 days period under a Low salicylate diet

Normal diet, then Low Salicylate diet

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

Group Type: EXPERIMENTAL

Normal Diet

Intervention Type: BEHAVIORAL

Participants followed a 7 days period under a Normal Diet

Interventions

Low salicylate diet

Participants followed a 7 days period under a Low salicylate diet

Intervention Type: BEHAVIORAL

Normal Diet

Participants followed a 7 days period under a Normal Diet

Intervention Type: BEHAVIORAL

Other Intervention Names

Dietary salicylate

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leigh J Sowerby, MD

Role: PRINCIPAL_INVESTIGATOR

Lawson HRI

Locations

St. Joseph's Health Care

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33892819 (View on PubMed)

Other Identifiers

103330

Identifier Type: -

Identifier Source: org_study_id