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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Low salycilate diet
Sponsored by
Instituto Nacional de Enfermedades Respiratorias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aspirin-exacerbated Respiratory Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Nacional de Enfermedades Respiratorias

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Low salycilate diet on day one and High salycilate diet on day 7

High salycilate diet on day one and Low salycilate diet on day 7

Outcomes

Primary Outcome Measures

Change from baseline in Urinary concentration of Leucotriene E4 (LTE4)
pg/ml of creatinine

Secondary Outcome Measures

Change from baseline in Expiratory Volume in 1 second (FEV-1)
Percentage of referenced value
Change from baseline in Vital Capacity (FVC)
Percentage of referenced value
Change from baseline in the Relationship between FEV1/FVC
Percentage of referenced value
Change from baseline in the total nasal resistance obtained by rhinometry
pascals/cm3/sec

Full Information

First Posted
February 6, 2019
Last Updated
June 3, 2019
Sponsor
Instituto Nacional de Enfermedades Respiratorias
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1. Study Identification

Unique Protocol Identification Number
NCT03973749
Brief Title
Effects of a High or Low Salycilate Diet on Urinary LTE4 and Clinical Features in AERD
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Anticipated)
Study Completion Date
May 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Enfermedades Respiratorias

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspirin-exacerbated Respiratory Disease, Aspirin-Sensitive Asthma With Nasal Polyps, Samter's Syndrome, Widal Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Low salycilate diet on day one and High salycilate diet on day 7
Arm Title
Group 2
Arm Type
Experimental
Arm Description
High salycilate diet on day one and Low salycilate diet on day 7
Intervention Type
Other
Intervention Name(s)
Low salycilate diet
Other Intervention Name(s)
High salycilate diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Urinary concentration of Leucotriene E4 (LTE4)
Description
pg/ml of creatinine
Time Frame
Baseline-4-8-12 hours in day one and Baseline-4-8-12 hours in day 7
Secondary Outcome Measure Information:
Title
Change from baseline in Expiratory Volume in 1 second (FEV-1)
Description
Percentage of referenced value
Time Frame
Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Title
Change from baseline in Vital Capacity (FVC)
Description
Percentage of referenced value
Time Frame
Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Title
Change from baseline in the Relationship between FEV1/FVC
Description
Percentage of referenced value
Time Frame
Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Title
Change from baseline in the total nasal resistance obtained by rhinometry
Description
pascals/cm3/sec
Time Frame
Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Instituto Nacional de Enfermedades Respiratorias
City
Mexico City
State/Province
Ciudad DE Mexico
ZIP/Postal Code
14080
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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

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