Low Salicylate Diet in Aspirin Exacerbated Respiratory Disease

Not Applicable

• Conditions: Aspirin Exacerbated Respiratory Disease; Samter's Triad
• Interventions: Behavioral: Normal diet; Behavioral: Low salicylate diet

• Registration Number: NCT01540032
• Lead Sponsor: Hamilton Health Sciences Corporation

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).

Detailed 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.

Study Timeline

• Status Verified: 2012-02
• Study Start: 2012-02
• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-22
• Last Update Submitted: 2012-02-22
• Study First Posted: 2012-02-28
• Last Update Posted: 2012-02-28
• Primary Completion: 2013-02
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Normal diet	-
Diet	Low salicylate diet	-

Primary Outcome Measures

Name	Time	Method
Change in SNOT-22 scores from Baseline	6 weeks and 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Lund-Kennedy Endoscopic Score from Baseline	6 weeks and 12 weeks	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.

Trial Locations

Locations (4)

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada