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. |
ClinicalTrials.gov Identifier: NCT01778465 |
Recruitment Status
:
Completed
First Posted
: January 29, 2013
Last Update Posted
: March 3, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 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 2013 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
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.
|
- Urinary levels of Cys-Leukotrienes [ Time Frame: 14 days after commencement ]
- Urinary salicylate levels [ Time Frame: 14 days after enrollment ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778465
Canada, Ontario | |
St. Joseph's Health Care | |
London, Ontario, Canada, N5A 4V2 |
Principal Investigator: | Leigh J Sowerby, MD | Lawson HRI |
Responsible Party: | Leigh Sowerby, Assistant Professor, Otolaryngology, Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT01778465 History of Changes |
Other Study ID Numbers: |
103330 |
First Posted: | January 29, 2013 Key Record Dates |
Last Update Posted: | March 3, 2015 |
Last Verified: | March 2015 |
Keywords provided by Leigh Sowerby, Lawson Health Research Institute:
Chronic Rhinosinusitis Aspirin exacerbated respiratory disease Asthma Aspirin sensitivity Salicylate |
Additional relevant MeSH terms:
Respiration Disorders Respiratory Tract Diseases Immune System Diseases Hypersensitivity Aspirin Salicylates Salicylic Acid Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Anti-Infective Agents Antifungal Agents Keratolytic Agents Dermatologic Agents |