Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease
This study is not yet open for participant recruitment.
Verified January 2013 by Lawson Health Research Institute
Sponsor:
Lawson Health Research Institute
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
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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
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 Salicylic Acid 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 |
ClinicalTrials.gov processed this record on May 16, 2013