Aspirin Exacerbated Respiratory DiseaseNCT01540032
Low Salicylate Diet in Aspirin Exacerbated Respiratory Disease
A study testing Low salicylate diet and Normal diet in people with Aspirin Exacerbated Respiratory Disease and Samter's Triad, run by Hamilton Health Sciences Corporation at 4 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspirin Exacerbated Respiratory Disease, Samter's Triad
- What is being tested?
- Low salicylate diet and Normal diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesCanada
- Study dates
- Feb 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of AERD
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Canada4 sites
Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
Doron Sommer, MD
St. Joseph's Health Care
London, Ontario, N6A 4V2
Brian Rotenberg, MD
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
John Lee, MD
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Allan Vescan, MD
About this study
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).
Read the 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.
- Being tested
- Low salicylate diet, Normal diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low salicylate dietBehavioural
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.
Normal dietBehavioural
Patients will eat their usual diet.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described Receives: Behavioral: Normal diet |
| Diet | Experimental | Not described Receives: Behavioral: Low salicylate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SNOT-22 scores from Baseline
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.
Measured: 6 weeks and 12 weeks
Secondary outcomes (1)
Change in Lund-Kennedy Endoscopic Score from Baseline
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.
Measured: 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspirin Exacerbated Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540032
- Sponsor's protocol ID
- AERD-01
- Status last verified
- Feb 2012
- First submitted
- 9 Feb 2012
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Salicylate Diet in Aspirin Exacerbated Respiratory Disease
- ClinicalTrials.gov ID
- NCT01540032
- Acronym / sponsor ID
- AERD-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | Behavioral: Normal diet |
| Diet | Experimental | Behavioral: Low salicylate diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of AERD
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low salicylate dietPatients 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. | Behavioural | Diet |
| Normal dietPatients will eat their usual diet. | Behavioural | Control |
Primary outcome
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.
1 secondary outcome
Change in Lund-Kennedy Endoscopic Score from Baseline
Time frame: 6 weeks and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low salicylate diet and Normal diet in people with Aspirin Exacerbated Respiratory Disease and Samter's Triad, run by Hamilton Health Sciences Corporation at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doron Sommer, MD (905-521-2100 ext. 73078, ddsommer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SNOT-22 scores from Baseline (time frame: 6 weeks and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.