Low Salicylate Diet in Aspirin Exacerbated Respiratory Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Hamilton Health Sciences Corporation.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01540032
First received: February 9, 2012
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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).


Condition Intervention
Aspirin Exacerbated Respiratory Disease
Samter's Triad
Behavioral: Low salicylate diet
Behavioral: Normal diet

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

Further study details as provided by Hamilton Health Sciences Corporation:

Primary Outcome Measures:
  • Change in SNOT-22 scores from Baseline [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Change in Lund-Kennedy Endoscopic Score from Baseline [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Behavioral: Normal diet
Patients will eat their usual diet.
Experimental: Diet 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540032

Contacts
Contact: Doron Sommer, MD 905-521-2100 ext 73078 ddsommer@hotmail.com

Locations
Canada, Ontario
Hamilton Health Sciences Not yet recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Principal Investigator: Doron Sommer, MD         
St. Joseph's Health Care Not yet recruiting
London, Ontario, Canada, N6A 4V2
Principal Investigator: Brian Rotenberg, MD         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: John Lee, MD         
Mount Sinai Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Principal Investigator: Allan Vescan, MD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT01540032     History of Changes
Other Study ID Numbers: AERD-01
Study First Received: February 9, 2012
Last Updated: February 22, 2012
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario
Canada: Public Health Agency of Canada

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Salicylates
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014