Effects of a High or Low Salycilate Diet on Urinary LTE4 and Clinical Features in AERD
AERD
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2017
CompletedFirst Submitted
Initial submission to the registry
February 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedFirst Posted
Study publicly available on registry
June 4, 2019
CompletedJune 4, 2019
June 1, 2019
2.3 years
February 6, 2019
June 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Change from baseline in Vital Capacity (FVC)
Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Change from baseline in the Relationship between FEV1/FVC
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
Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Study Arms (2)
Group 1
EXPERIMENTALLow salycilate diet on day one and High salycilate diet on day 7
Group 2
EXPERIMENTALHigh salycilate diet on day one and Low salycilate diet on day 7
Interventions
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.
Eligibility Criteria
You may qualify if:
- Confirmed Aspirin exacerbated respiratory disease.
- Controled asthma
- No actual systemic corticosteroid treatment
- No antileucotriene treatment.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico City, 14080, Mexico
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 6, 2019
First Posted
June 4, 2019
Study Start
February 2, 2017
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
June 4, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share