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

Not Applicable

• Conditions: Aspirin-Sensitive Asthma With Nasal Polyps; Aspirin-exacerbated Respiratory Disease; Widal Syndrome; Samter's Syndrome
• Interventions: Other: Low salycilate diet

• Registration Number: NCT03973749
• Lead Sponsor: Instituto Nacional de Enfermedades Respiratorias

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-02
• Study First Submitted: 2019-02-06
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-03
• Last Update Submitted: 2019-06-03
• Study First Posted: 2019-06-04
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	Low salycilate diet	High salycilate diet on day one and Low salycilate diet on day 7
Group 1	Low salycilate diet	Low salycilate diet on day one and High salycilate diet on day 7

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 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 the Relationship between FEV1/FVC	Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7	Percentage of referenced value

Trial Locations

Locations (1)

Instituto Nacional de Enfermedades Respiratorias; 🇲🇽 Mexico City, Ciudad DE Mexico, Mexico