Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low salicylate diet, then Normal Diet | Experimental | Patients followed a low salicylate diet for one week, then they followed a Normal diet for another week. |
|
| Normal diet, then Low Salicylate diet | Experimental | Patients followed a Normal diet for one week, then they followed a Low Salicylate diet for another week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low salicylate diet | Behavioral | Participants followed a 7 days period under a Low salicylate diet |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leigh J Sowerby, MD | Lawson HRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Health Care | London | Ontario | N5A 4V2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33892819 | Derived | Sowerby LJ, Patel KB, Schmerk C, Rotenberg BW, Rocha T, Sommer DD. Effect of low salicylate diet on clinical and inflammatory markers in patients with aspirin exacerbated respiratory disease - a randomized crossover trial. J Otolaryngol Head Neck Surg. 2021 Apr 23;50(1):27. doi: 10.1186/s40463-021-00502-4. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Low Salicylate Diet, Then Normal Diet | Participants followed a low salicylate diet for 7 days, then they started a period of 7 days on Normal diet. |
| FG001 | Normal Diet, Then Low Salicylate Diet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Normal Diet | Behavioral | Participants followed a 7 days period under a Normal Diet |
|
| 14 days after commencement |
Participants followed a normal diet for 7 days, then they started a period of 7 days on Low Salicylate Diet
| COMPLETED |
|
| NOT COMPLETED |
|
| Second Intervention (7 Days) |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants followed a low salicylate diet for one week. Then, participants continued with a normal diet for one week. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urinary Levels of Cys-Leukotrienes | Posted | Median | Inter-Quartile Range | pg/ml | 14 days after commencement |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Urinary Salicyluric Acid Levels | Posted | Median | Inter-Quartile Range | ng/ml | 14 days after commencement |
|
| |||||||||||||||||||||||||||||||
| Primary | Urinary Salicylic Acid Levels | Posted | Median | Inter-Quartile Range | ng/ml | 14 days after enrollment |
|
| |||||||||||||||||||||||||||||||
| Primary | Urinary Creatinine Levels | Posted | Median | Inter-Quartile Range | mmol/L | 14 days after commencement |
|
| |||||||||||||||||||||||||||||||
| 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) | Posted | Median | Inter-Quartile Range | score on a scale | 14 days after commencement |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Salicylate Diet | Participants followed a low salicylate diet for 7 days | 0 | 7 | 0 | 7 | 0 | 7 |
| EG001 | Normal Diet | Participants followed a normal diet for 7 days | 0 | 7 | 0 | 7 | 0 | 7 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Program Coordinator | Western University | +15196466100 | 61125 | taciano.rocha@sjhc.london.on.ca |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
|
|
|
|