NCT01778465

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

March 9, 2021

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

January 26, 2013

Results QC Date

July 15, 2020

Last Update Submit

February 17, 2021

Conditions

Chronic RhinosinusitisAspirin Exacerbated Respiratory DiseaseAsthmaAspirin Sensitivity

Keywords

Chronic RhinosinusitisAspirin exacerbated respiratory diseaseAsthmaAspirin sensitivitySalicylate

Outcome Measures

Primary Outcomes (4)

  • Urinary Levels of Cys-Leukotrienes

    14 days after commencement

  • Urinary Salicyluric Acid Levels

    14 days after commencement

  • Urinary Salicylic Acid Levels

    14 days after enrollment

  • Urinary Creatinine Levels

    14 days after commencement

Secondary Outcomes (1)

  • Sino-Nasal Outcome Test (SNOT-22)

    14 days after commencement

Study Arms (2)

Low salicylate diet, then Normal Diet

EXPERIMENTAL

Patients followed a low salicylate diet for one week, then they followed a Normal diet for another week.

Behavioral: Low salicylate diet

Normal diet, then Low Salicylate diet

EXPERIMENTAL

Patients followed a Normal diet for one week, then they followed a Low Salicylate diet for another week.

Behavioral: Normal Diet

Interventions

Low salicylate dietBEHAVIORAL

Participants followed a 7 days period under a Low salicylate diet

Also known as: Dietary salicylate
Low salicylate diet, then Normal Diet
Normal DietBEHAVIORAL

Participants followed a 7 days period under a Normal Diet

Normal diet, then Low Salicylate diet

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients
  • Aspirin-exacerbated respiratory disease

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N5A 4V2, Canada

Location

Related Publications (1)

  • Sowerby LJ, Patel KB, Schmerk C, Rotenberg BW, Rocha T, Sommer DD. Effect of low salicylate diet on clinical and inflammatory markers in patients with aspirin exacerbated respiratory disease - a randomized crossover trial. J Otolaryngol Head Neck Surg. 2021 Apr 23;50(1):27. doi: 10.1186/s40463-021-00502-4.

    PMID: 33892819DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Clinical Trials Program Coordinator
Organization
Western University
taciano.rocha@sjhc.london.on.ca
+15196466100

Study Officials

  • Leigh J Sowerby, MD

    Lawson HRI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2013

First Posted

January 29, 2013

Study Start

May 1, 2013

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

March 9, 2021

Results First Posted

March 9, 2021

Record last verified: 2015-03

Locations

CA(1)