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

June 3, 2019 updated by: Marcos Alejandro Jimenez Chobillon, Instituto Nacional de Enfermedades Respiratorias

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Ciudad DE Mexico
      • Mexico City, Ciudad DE Mexico, Mexico, 14080
        • Instituto Nacional de Enfermedades Respiratorias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Low salycilate diet on day one and High salycilate diet on day 7
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.
Other Names:
  • High salycilate diet
Experimental: Group 2
High salycilate diet on day one and Low salycilate diet on day 7
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.
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)
Time Frame: Baseline-4-8-12 hours in day one and Baseline-4-8-12 hours in day 7
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)
Time Frame: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
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)
Time Frame: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
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
Time Frame: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
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
Time Frame: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
pascals/cm3/sec
Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Enfermedades Respiratorias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2017

Primary Completion (Anticipated)

May 31, 2019

Study Completion (Anticipated)

May 31, 2019

Study Registration Dates

First Submitted

February 6, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C13-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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