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Low Salicylate Diet in Aspirin Exacerbated Respiratory Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Hamilton Health Sciences Corporation.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01540032
First Posted: February 28, 2012
Last Update Posted: February 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation
February 9, 2012
February 28, 2012
February 28, 2012
February 2012
February 2013   (Final data collection date for primary outcome measure)
Change in SNOT-22 scores from Baseline [ Time Frame: 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.
Same as current
No Changes Posted
Change in Lund-Kennedy Endoscopic Score from Baseline [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
Low Salicylate Diet in Aspirin Exacerbated Respiratory Disease
Not Provided
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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Aspirin Exacerbated Respiratory Disease
  • Samter's Triad
  • 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.
  • Behavioral: Normal diet
    Patients will eat their usual diet.
  • No Intervention: Control
    Intervention: Behavioral: Normal diet
  • Experimental: Diet
    Intervention: Behavioral: Low salicylate diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01540032
AERD-01
No
Not Provided
Not Provided
Hamilton Health Sciences Corporation
Hamilton Health Sciences Corporation
Not Provided
Not Provided
Hamilton Health Sciences Corporation
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP