Aspirin Exacerbated Respiratory Disease, Aspirin Sensitivity, Asthma, Chronic Rhinosinusitis
Conditions
Keywords
Chronic Rhinosinusitis, Aspirin exacerbated respiratory disease, Asthma, Aspirin sensitivity, Salicylate
Brief 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.
Interventions
BEHAVIORALLow salicylate diet
Participants followed a 7 days period under a Low salicylate diet
BEHAVIORALNormal Diet
Participants followed a 7 days period under a Normal Diet
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary Levels of Cys-Leukotrienes | 14 days after commencement |
| Urinary Salicyluric Acid Levels | 14 days after commencement |
| Urinary Salicylic Acid Levels | 14 days after enrollment |
| Urinary Creatinine Levels | 14 days after commencement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sino-Nasal Outcome Test (SNOT-22) | 14 days after commencement | The Sino-Nasal Outcome Test (SNOT-22) is a validated 22-item Chronic rhinosinusitis-specific instrument which is scored using a scale where 0=No problem, 1=Very mild problem, 2=Mild or slight problem, 3=Moderate problem, 4=Severe problem, and 5=Problem as bad as it can be. Higher scores on the SNOT-22 survey items suggest worse patient functioning or symptom severity (total score range: 0-110) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participants followed a low salicylate diet for one week. Then, participants continued with a normal diet for one week. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 13.1 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
Urinary Creatinine Levels
Time frame: 14 days after commencement
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Salicylate Diet | Urinary Creatinine Levels | 9.9 mmol/L |
| Normal Diet | Urinary Creatinine Levels | 15.3 mmol/L |
Primary
Urinary Levels of Cys-Leukotrienes
Time frame: 14 days after commencement
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Salicylate Diet | Urinary Levels of Cys-Leukotrienes | 874.05 pg/ml |
| Normal Diet | Urinary Levels of Cys-Leukotrienes | 771.99 pg/ml |
Primary
Urinary Salicylic Acid Levels
Time frame: 14 days after enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Salicylate Diet | Urinary Salicylic Acid Levels | 0.6 ng/ml |
| Normal Diet | Urinary Salicylic Acid Levels | 0.92 ng/ml |
Primary
Urinary Salicyluric Acid Levels
Time frame: 14 days after commencement
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Salicylate Diet | Urinary Salicyluric Acid Levels | 44.21 ng/ml |
| Normal Diet | Urinary Salicyluric Acid Levels | 23.82 ng/ml |
Secondary
Sino-Nasal Outcome Test (SNOT-22)
The Sino-Nasal Outcome Test (SNOT-22) is a validated 22-item Chronic rhinosinusitis-specific instrument which is scored using a scale where 0=No problem, 1=Very mild problem, 2=Mild or slight problem, 3=Moderate problem, 4=Severe problem, and 5=Problem as bad as it can be. Higher scores on the SNOT-22 survey items suggest worse patient functioning or symptom severity (total score range: 0-110)
Time frame: 14 days after commencement
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Salicylate Diet | Sino-Nasal Outcome Test (SNOT-22) | 44 score on a scale |
| Normal Diet | Sino-Nasal Outcome Test (SNOT-22) | 66 score on a scale |