N/A
Completed N=7
Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease
chronic rhinosinusitis · Aspirin Exacerbated Respiratory Disease · Asthma · Aspirin Sensitivity
Source: ClinicalTrials.gov NCT01778465 ↗
Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Urinary Levels of Cys-Leukotrienes — 874.05; 771.99 pg/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Levels of Cys-Leukotrienes |
874.05; 771.99 | — |
| PRIMARY Urinary Salicyluric Acid Levels |
44.21; 23.82 | — |
| PRIMARY Urinary Salicylic Acid Levels |
0.6; 0.92 | — |
| PRIMARY Urinary Creatinine Levels |
9.9; 15.3 | — |
| SECONDARY Sino-Nasal Outcome Test (SNOT-22) |
44; 66 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01778465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.