Effects of a High or Low Salycilate Diet on Urinary LTE4 and Clinical Features in AERD

Study Overview
=================
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.

Official Title
-----------------
Effects of a High or Low Salycilate Diet on Urinary Leucotriene E4 Levels and Clinical Features in Patients With Aspirin Exacerbated Respiratory Disease

Conditions
-----------------
Samter's Syndrome, Aspirin-exacerbated Respiratory Disease, Aspirin-Sensitive Asthma With Nasal Polyps, Widal Syndrome

Intervention / Treatment
-----------------
* Other: Low salycilate diet


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Low salycilate diet on day one and High salycilate diet on day 7 | Other: Low salycilate diet<br>* 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.<br>* Other names: High salycilate diet;|
| Experimental: Group 2<br>High salycilate diet on day one and Low salycilate diet on day 7 | Other: Low salycilate diet<br>* 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.<br>* Other names: High salycilate diet;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Urinary concentration of Leucotriene E4 (LTE4) | pg/ml of creatinine | Baseline-4-8-12 hours in day one and Baseline-4-8-12 hours in day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Expiratory Volume in 1 second (FEV-1) | Percentage of referenced value | Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7 | 
| Change from baseline in Vital Capacity (FVC) | Percentage of referenced value | Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7 | 
| Change from baseline in the Relationship between FEV1/FVC | Percentage of referenced value | Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7 | 
| Change from baseline in the total nasal resistance obtained by rhinometry | pascals/cm3/sec | Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7 |