Chronic RhinosinusitisNCT01778465
Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease
A study testing Low salicylate diet and Normal Diet in people with Chronic Rhinosinusitis and Aspirin Exacerbated Respiratory Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Aspirin-Exacerbated Respiratory Disease, or AERD, consists of aspirin sensitivity, asthma and nasal polyps. It is currently managed by chronic steroid use, multiple endoscopic sinus surgeries and/or aspirin desensitization. However, these treatments have potential adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Rhinosinusitis, Aspirin Exacerbated Respiratory Disease, Asthma
- 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
- 7 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- Aspirin-exacerbated respiratory disease
Who cannot join
- recent use of Prednisone or other systemic steroids (greater than 3 doses in past 3 months)
- Endoscopic sinus surgery or polypectomy within the past 6 months
- Other significant systemic disease, including renal failure, or immunocompromised state.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low Dietary Salicylate on Biochemical Markers of Aspirin Exacerbated Respiratory Disease
Aspirin-Exacerbated Respiratory Disease, or AERD, consists of aspirin sensitivity, asthma and nasal polyps. It is currently managed by chronic steroid use, multiple endoscopic sinus surgeries and/or aspirin desensitization. However, these treatments have potential adverse effects.
A theory has been postulated that decreasing the level of dietary salicylates may help in long-term control of disease. A current trial is in the works to evaluate the clinical outcomes of decreased salicylate, but measurements of biochemical markers of disease has not yet been done. The hypothesis is that decreased dietary salicylates will result in a decrease in urinary salicylates and inflammatory markers of disease, cys-leukotrienes, which are typically elevated in this disease.
- Conditions
- Chronic Rhinosinusitis, Aspirin Exacerbated Respiratory Disease, Asthma, Aspirin Sensitivity
- Being tested
- Low salicylate diet, Normal Diet
- Keywords
- Chronic Rhinosinusitis, Aspirin exacerbated respiratory disease, Asthma, Aspirin sensitivity, Salicylate
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low salicylate dietBehavioural
Also called Dietary salicylate
Participants followed a 7 days period under a Low salicylate diet
Normal DietBehavioural
Participants followed a 7 days period under a Normal Diet
| Study group | Role | What they receive |
|---|---|---|
| Low salicylate diet, then Normal Diet | Experimental | Patients followed a low salicylate diet for one week, then they followed a Normal diet for another week. Receives: Behavioral: Low salicylate diet |
| Normal diet, then Low Salicylate diet | Experimental | Patients followed a Normal diet for one week, then they followed a Low Salicylate diet for another week. Receives: Behavioral: Normal Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Levels of Cys-Leukotrienes
Measured: 14 days after commencement
Urinary Salicyluric Acid Levels
Measured: 14 days after commencement
Urinary Salicylic Acid Levels
Measured: 14 days after enrollment
Urinary Creatinine Levels
Measured: 14 days after commencement
Secondary outcomes (1)
Sino-Nasal Outcome Test (SNOT-22)
The Sino-Nasal Outcome Test (SNOT-22) is a validated 22-item Chronic rhinosinusitis-specific instrument which is scored using a scale where 0="No problem", 1="Very mild problem", 2="Mild or slight problem", 3="Moderate problem", 4="Severe problem", and 5="Problem as bad as it can be". Higher scores on the SNOT-22 survey items suggest worse patient functioning or symptom severity (total score range: 0-110)
Measured: 14 days after commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh J Sowerby, MD, Principal investigator, Lawson HRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778465
- Sponsor's protocol ID
- 103330
- Status last verified
- Mar 2015
- First submitted
- 26 Jan 2013
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sowerby LJ, Patel KB, Schmerk C, Rotenberg BW, Rocha T, Sommer DD. Effect of low salicylate diet on clinical and inflammatory markers in patients with aspirin exacerbated respiratory disease - a randomized crossover trial. J Otolaryngol Head Neck Surg. 2021 Apr 23;50(1):27. doi: 10.1186/s40463-021-00502-4.
PubMed 33892819
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Dietary Salicylate on Biochemical Markers of Aspirin Exacerbated Respiratory Disease
- ClinicalTrials.gov ID
- NCT01778465
- Acronym / sponsor ID
- 103330
- Conditions
- Chronic Rhinosinusitis, Aspirin Exacerbated Respiratory Disease, Asthma, Aspirin Sensitivity
- Keywords
- Chronic Rhinosinusitis, Aspirin exacerbated respiratory disease, Asthma, Aspirin sensitivity, Salicylate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Posted 9 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aspirin-Exacerbated Respiratory Disease, or AERD, consists of aspirin sensitivity, asthma and nasal polyps. It is currently managed by chronic steroid use, multiple endoscopic sinus surgeries and/or aspirin desensitization. However, these treatments have potential adverse effects.
A theory has been postulated that decreasing the level of dietary salicylates may help in long-term control of disease. A current trial is in the works to evaluate the clinical outcomes of decreased salicylate, but measurements of biochemical markers of disease has not yet been done. The hypothesis is that decreased dietary salicylates will result in a decrease in urinary salicylates and inflammatory markers of disease, cys-leukotrienes, which are typically elevated in this disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low salicylate diet, then Normal Diet | Experimental | Behavioral: Low salicylate dietPatients followed a low salicylate diet for one week, then they followed a Normal diet for another week. |
| Normal diet, then Low Salicylate diet | Experimental | Behavioral: Normal DietPatients followed a Normal diet for one week, then they followed a Low Salicylate diet for another week. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients
- Aspirin-exacerbated respiratory disease
Key exclusion criteria (3 listed)
- recent use of Prednisone or other systemic steroids (greater than 3 doses in past 3 months)
- Endoscopic sinus surgery or polypectomy within the past 6 months
- Other significant systemic disease, including renal failure, 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 dietAlso: Dietary salicylateParticipants followed a 7 days period under a Low salicylate diet | Behavioural | Low salicylate diet, then Normal Diet |
| Normal DietParticipants followed a 7 days period under a Normal Diet | Behavioural | Normal diet, then Low Salicylate diet |
Primary outcome
Urinary Levels of Cys-Leukotrienes
Time frame: 14 days after commencement
Urinary Salicyluric Acid Levels
Time frame: 14 days after commencement
Urinary Salicylic Acid Levels
Time frame: 14 days after enrollment
Urinary Creatinine Levels
Time frame: 14 days after commencement
1 secondary outcome
Sino-Nasal Outcome Test (SNOT-22)
Time frame: 14 days after commencement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33892819Sowerby LJ, Patel KB, Schmerk C, Rotenberg BW, Rocha T, Sommer DD. Effect of low salicylate diet on clinical and inflammatory markers in patients with aspirin exacerbated respiratory disease - a randomized crossover trial. J Otolaryngol Head Neck Surg. 2021 Apr 23;50(1):27. doi: 10.1186/s40463-021-00502-4.
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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.
Leigh J Sowerby, MD principal investigator
Lawson HRI
1 site 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 Chronic Rhinosinusitis and Aspirin Exacerbated Respiratory Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site 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 2 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: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 9 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Levels of Cys-Leukotrienes (time frame: 14 days after commencement). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01778465, which also lists 1 linked publication.
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 9 Mar 2021.