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

N

National Institute of Respiratory Diseases (INER)

Status

Unknown

Conditions

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

Treatments

Other: Low salycilate diet

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Group 1
Experimental group
Description:
Low salycilate diet on day one and High salycilate diet on day 7
Treatment:
Other: Low salycilate diet
Group 2
Experimental group
Description:
High salycilate diet on day one and Low salycilate diet on day 7
Treatment:
Other: Low salycilate diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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