Low Salicylate Diet in Aspirin Exacerbated Respiratory Disease
1 other identifier
interventional
80
1 country
4
Brief Summary
The purpose of this study is to determine whether a low salicylate diet will improve the quality of life of patients with Aspirin Exacerbated Respiratory Disease (AERD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2012
4 active sites
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 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 9, 2012
CompletedFirst Posted
Study publicly available on registry
February 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFebruary 28, 2012
February 1, 2012
1 year
February 9, 2012
February 22, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change in SNOT-22 scores from Baseline
As this is a crossover study, all participants will complete the SNOT-22 questionnaire at the beginning of the study. After 6 weeks of their assigned diet (normal vs low salicylate), they will complete the SNOT-22 questionnaire to see if there are any differences in subjective nasal and sinus symptoms. After 6 weeks, the participants cross over to the other diet and they will complete the SNOT-22 questionnaire again in another 6 weeks when the study ends.
6 weeks and 12 weeks
Secondary Outcomes (1)
Change in Lund-Kennedy Endoscopic Score from Baseline
6 weeks and 12 weeks
Study Arms (2)
Control
NO INTERVENTIONDiet
EXPERIMENTALInterventions
Patients will avoid foods from the 'high salicylate' group completely. They can eat foods from the 'low salicylate' group freely and just eat foods from the medium group occasionally, and not in large amounts.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of AERD
You may not qualify if:
- Recent use of Prednisone or other systemic steroid (greater than three (3) doses in past three (3) months). This does not include the use of nasal steroids.
- Endoscopic sinus surgery / polypectomy within the past six (6) months
- Other significant systemic disease or immunocompromised state
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5, Canada
St. Joseph's Health Care
London, Ontario, N6A 4V2, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2012
First Posted
February 28, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
February 28, 2012
Record last verified: 2012-02