Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Leigh Sowerby, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01778465
First received: January 26, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Intervention
Chronic Rhinosinusitis
Aspirin Exacerbated Respiratory Disease
Asthma
Aspirin Sensitivity
Behavioral: Low salicylate diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Low Dietary Salicylate on Biochemical Markers of Aspirin Exacerbated Respiratory Disease

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Urinary levels of Cys-Leukotrienes [ Time Frame: 14 days after commencement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary salicylate levels [ Time Frame: 14 days after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low salicylate diet
Patients are to follow a low salicylate diet for one week.
Behavioral: Low salicylate diet
Other Name: Dietary salicylate
No Intervention: Normal diet
Patients are to continue with a normal diet for one week. There is then cross-over after one week for a further week into the intervention group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778465

Contacts
Contact: Leigh J Sowerby, MD 519-646-6143 leigh.sowerby@sjhc.london.on.ca

Locations
Canada, Ontario
St. Joseph's Health Care Not yet recruiting
London, Ontario, Canada, N5A 4V2
Contact: Leigh J Sowerby         
Principal Investigator: Leigh J Sowerby, MD         
Sub-Investigator: Brian Rotenberg, MD         
Sub-Investigator: Krupal Patel, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Leigh J Sowerby, MD Lawson HRI
  More Information

No publications provided

Responsible Party: Leigh Sowerby, Assistant Professor, Otolaryngology, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01778465     History of Changes
Other Study ID Numbers: 103330
Study First Received: January 26, 2013
Last Updated: January 26, 2013
Health Authority: Canada: MOHTLC

Keywords provided by Lawson Health Research Institute:
Chronic Rhinosinusitis
Aspirin exacerbated respiratory disease
Asthma
Aspirin sensitivity
Salicylate

Additional relevant MeSH terms:
Asthma
Respiration Disorders
Respiratory Tract Diseases
Sinusitis
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Aspirin
Salicylates
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014