Low Salicylate Diet in Aspirin Exacerbated Respiratory Disease

Aspirin Exacerbated Respiratory Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01540032
• Other study ID #: AERD-01
• Status: Not yet recruiting
• Phase: N/A
• First received: February 9, 2012
• Last updated: February 22, 2012
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2012
• Source: Hamilton Health Sciences Corporation
• Contact: Doron Sommer, MD
• Phone: 905-521-2100
• Email: ddsommer[@]hotmail.com
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Ethics Review CommitteeCanada: Health CanadaCanada: Ministry of Health & Long Term Care, OntarioCanada: Public Health Agency of Canada
• Study type: Interventional

Clinical Trial 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).

Description:

Aspirin-exacerbated respiratory disease (AERD) is clinically diagnosed in patients who suffer from allergy to aspirin, asthma, nasal polyps, and chronic sinusitis. Patients with AERD are often resistant to medical management of nasal polyps, and require multiple endoscopic sinus surgeries to manage recurrences of nasal polyps. Control of AERD can be obtained through aspirin desensitization, which consists of taking aspirin every day. However, there are substantial risks and adverse side effects to taking moderate amounts of aspirin daily. Furthermore, patients experience progressively worsening nasal and respiratory disease even with complete avoidance of aspirin and other NSAIDs.

The active and major component in aspirin/NSAIDs is salicylate, which is also found naturally in some foods. Diet modification is a cost-effective intervention that has the potential to provide long-term remission of AERD. Our study will evaluate whether a low salicylate diet, which is a more cost effective and benign intervention with minimal risks, will improve nasal, sinus or respiratory symptoms, such as congestion, sinusitis, smell, or asthma.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of AERD

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspirin Exacerbated Respiratory Disease
• Respiration Disorders
• Respiratory Tract Diseases
• Samter's Triad

Intervention

Behavioral:
• Low salicylate diet
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.
• Normal diet
Patients will eat their usual diet.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	St. Joseph's Health Care	London	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Lund-Kennedy Endoscopic Score from Baseline	As this is a crossover study, all participants will be evaluated for the Lund-Kennedy Endoscopic Score at the beginning of the study. After 6 weeks of their assigned diet (normal vs low salicylate), they will be re-evaluated in clinic to see if there are any differences in endoscopy findings. After 6 weeks, the participants cross over to the other diet and they will have a final endoscopic evaluation in another 6 weeks when the study ends.	6 weeks and 12 weeks	No