Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01778465
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : March 3, 2015
Information provided by (Responsible Party):
Leigh Sowerby, Lawson Health Research Institute

January 26, 2013
January 29, 2013
March 3, 2015
May 2013
March 2014   (Final data collection date for primary outcome measure)
Urinary levels of Cys-Leukotrienes [ Time Frame: 14 days after commencement ]
Same as current
Complete list of historical versions of study NCT01778465 on Archive Site
Urinary salicylate levels [ Time Frame: 14 days after enrollment ]
Same as current
Not Provided
Not Provided
Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease
Effect of Low Dietary Salicylate on Biochemical Markers of Aspirin Exacerbated Respiratory Disease

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.

Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Chronic Rhinosinusitis
  • Aspirin Exacerbated Respiratory Disease
  • Asthma
  • Aspirin Sensitivity
Behavioral: Low salicylate diet
Other Name: Dietary salicylate
  • Experimental: Low salicylate diet
    Patients are to follow a low salicylate diet for one week.
    Intervention: Behavioral: Low salicylate diet
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2014
March 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Leigh Sowerby, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: Leigh J Sowerby, MD Lawson HRI
Lawson Health Research Institute
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP