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

Aspirin-exacerbated Respiratory Disease Clinical Trial

— AERD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03973749
• Other study ID #: C13-17
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: June 2019
• Source: Instituto Nacional de Enfermedades Respiratorias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspirin-exacerbated Respiratory Disease
• Aspirin-Sensitive Asthma With Nasal Polyps
• Nasal Polyps
• Respiration Disorders
• Respiratory Tract Diseases
• Samter's Syndrome
• Syndrome
• Widal Syndrome

Intervention

Other:
• Low 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.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Enfermedades Respiratorias	Mexico City	Ciudad DE Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Enfermedades Respiratorias

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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