Low Salicylate Diet in Aspirin Exacerbated Respiratory Disease

NCT ID: NCT01540032

Last Updated: 2012-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Aspirin Exacerbated Respiratory Disease Samter's Triad

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Group Type NO_INTERVENTION

Normal diet

Intervention Type BEHAVIORAL

Patients will eat their usual diet.

Diet

Group Type EXPERIMENTAL

Low salicylate diet

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Normal diet

Patients will eat their usual diet.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

St. Joseph's Health Care

London, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Doron Sommer, MD

Role: CONTACT

Phone: 905-521-2100

Email: [email protected]

Other Identifiers

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AERD-01

Identifier Type: -

Identifier Source: org_study_id