Low Salicylate Diet in Aspirin Exacerbated Respiratory Disease

Hamilton Health Sciences (HHS)

Status: Unknown

Conditions: Aspirin Exacerbated Respiratory Disease; Samter's Triad

Treatments: Behavioral: Low salicylate diet; Behavioral: Normal diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01540032

AERD-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Control

No Intervention group

Treatment:

Behavioral: Normal diet

Diet

Experimental group

Treatment:

Behavioral: Low salicylate diet