Aspirin-exacerbated Respiratory Disease, Aspirin-Sensitive Asthma With Nasal Polyps, Samter's Syndrome, Widal Syndrome
Conditions
Brief summary
On day one, two groups of nine patients each will respectively recieve the tree daily meals (breakfast, Lunch and dinner) in a controled clinical setting. Group 1 will recieve a low-salycilate diet, and group 2 a high-salycilate diet. Two hours after each meal, urinary Leucotriene E4, FEV1, FVC, FEV1/FVC and total nasal resistance will be measured. On day 7, after clearance time, group 1 will recieve high-salycilate diet and group 2 low salycilate diet and the same measurements will be obtained.
Interventions
OTHERLow salycilate diet
Each arm of the experimental group will be exposed to low and high concentrations of dietary salycilates and urinary LTE4, FEV1, FVC, FEV1/FVC and total inspiratory nasal resistance will be measured at basal level and then two hours after each of the 3 daily meals.
Sponsors
Instituto Nacional de Enfermedades Respiratorias
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed Aspirin exacerbated respiratory disease. * Controled asthma * No actual systemic corticosteroid treatment * No antileucotriene treatment.
Exclusion criteria
* Patients who do not complete both phases of the study * Patients unable to perform adecuate spyrometric testing * Patients who present severe asthmatic reactions with high salycilate foods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Urinary concentration of Leucotriene E4 (LTE4) | Baseline-4-8-12 hours in day one and Baseline-4-8-12 hours in day 7 | pg/ml of creatinine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Expiratory Volume in 1 second (FEV-1) | Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7 | Percentage of referenced value |
| Change from baseline in Vital Capacity (FVC) | Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7 | Percentage of referenced value |
| Change from baseline in the Relationship between FEV1/FVC | Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7 | Percentage of referenced value |
| Change from baseline in the total nasal resistance obtained by rhinometry | Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7 | pascals/cm3/sec |
Countries
Mexico
Outcome results
None listed