Skip to main content
OpenTrials
Completed

NCT Number: NCT01778465

Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

Aspirin-Exacerbated Respiratory Disease, or AERD, consists of aspirin sensitivity, asthma and nasal polyps. It is currently managed by chronic steroid use, multiple endoscopic sinus surgeries and/or aspirin desensitization. However, these treatments have potential adverse effects.

A theory has been postulated that decreasing the level of dietary salicylates may help in long-term control of disease. A current trial is in the works to evaluate the clinical outcomes of decreased salicylate, but measurements of biochemical markers of disease has not yet been done. The hypothesis is that decreased dietary salicylates will result in a decrease in urinary salicylates and inflammatory markers of disease, cys-leukotrienes, which are typically elevated in this disease.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Rhinosinusitis Aspirin Exacerbated Respiratory Disease Aspirin Sensitivity Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Health Care

London, Ontario, N5A 4V2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients
  • Aspirin-exacerbated respiratory disease

Exclusion criteria

  • recent use of Prednisone or other systemic steroids (greater than 3 doses in past 3 months)
  • Endoscopic sinus surgery or polypectomy within the past 6 months
  • Other significant systemic disease, including renal failure, or immunocompromised state.

Treatment and study plan

Low salicylate diet

Behavioral

Participants followed a 7 days period under a Low salicylate diet

Other names: Dietary salicylate

Normal Diet

Behavioral

Participants followed a 7 days period under a Normal Diet

Primary outcomes

  1. Urinary Levels of Cys-Leukotrienes

    Time frame: 14 days after commencement

  2. Urinary Salicyluric Acid Levels

    Time frame: 14 days after commencement

  3. Urinary Salicylic Acid Levels

    Time frame: 14 days after enrollment

  4. Urinary Creatinine Levels

    Time frame: 14 days after commencement

Secondary outcomes

  1. Sino-Nasal Outcome Test (SNOT-22)

    Time frame: 14 days after commencement

    The Sino-Nasal Outcome Test (SNOT-22) is a validated 22-item Chronic rhinosinusitis-specific instrument which is scored using a scale where 0="No problem", 1="Very mild problem", 2="Mild or slight problem", 3="Moderate problem", 4="Severe problem", and 5="Problem as bad as it can be". Higher scores on the SNOT-22 survey items suggest worse patient functioning or symptom severity (total score range: 0-110)

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

Effect of Low Dietary Salicylate on Biochemical Markers of Aspirin Exacerbated Respiratory Disease

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2013
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.