Chronic Rhinosinusitis (Diagnosis)AJESSNCT04514120
Alsaleh-Javer Endoscopic Sinus Score (AJESS) System
A study testing AJESS scoring process in people with Chronic Rhinosinusitis (Diagnosis), run by St. Paul's Hospital, Canada.
Trial summary
Several endoscopic scores have been developed to assess Chronic Rhinosinusitis severity like the Modified Lund-Kennedy (MLK). This is a simple score only based on endoscopic signs. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- AJESS scoring process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Sep 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are over 19 years old
- Patients diagnosed with Chronic Rhinosinusitis including those with or without nasal polyposis and with Allergic Fungal Rhinosinusitis
- Post-operative patients
Who cannot join
- Have a sinonasal neoplasm
- Have syndromic sinusitis e.g. cystic fibrosis or vasculitis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Development and Validation of a Descriptive and Clinically Relevant Postoperative Endoscopic Sinus Scoring System
Several endoscopic scores have been developed to assess Chronic Rhinosinusitis severity like the Modified Lund-Kennedy (MLK). This is a simple score only based on endoscopic signs. We proposed a more descriptive Alsaleh-Javer Endoscopic Sinus Score (AJESS) system which assesses all sinuses and nasal passages based on participant's severity of symptoms too. This would be a more reliable and clinically valid CRS endoscopic score. We aim to study thE AJESS system in 100 participants with stable CRS and 30 participants CRS who are experiencing an exacerbation (worsening of CRS).
Read the detailed description
Chronic rhinosinusitis (CRS) is a prevalent inflammatory disorder of the nasal passages and sinuses associated with detrimental effects on quality of life and productivity as well as billions of dollars in healthcare expenses and lost productivity each year. Numerous endoscopic scoring systems have been developed to assess CRS disease severity such as the popular Modified Lund-Kennedy (MLK) score which assesses sinus cavities only based on 3 criteria (polyps, edema, and discharge) with small 0-2 integer scales. Yet, such systems at best have reported good to moderate reliabilities and weak to no correlation with patient-reported outcome measures (PROMs) which should motivate further research to develop a more reliable and clinically valid CRS endoscopic scoring system, especially one which can better align the observed endoscopic signs of disease with the severity of symptoms reported by patients. In this study we propose a more descriptive Alsaleh-Javer Endoscopic Sinus Score (AJESS) system which assesses all sinuses and nasal passages with a numerical score of inflammation severity, alphabetical score for presence of CRS features, and an aggregated numerical score of overall disease severity. Our mixed-methods clinical study of 100 stable post-operative CRS patients and 30 post-operative CRS patients experiencing an exacerbation who are visiting St. Paul's Sinus Centre will gather both cross-sectional (1 visit, CRS stable) and prospective (2 follow-up visits approximately 2-4 weeks apart each, CRS flares) clinical data including two PROMs (SNOT-22, VAS) and an objective olfactory sensation test (Sniffin' Sticks TDI Score) to assess AJESS and MLK scores in terms of inter-rater reliability, test-retest reliability, correlation with clinical data, and responsiveness to changes in clinical data. Pending validation and head-to-head analysis with the MLK score, the AJESS system may be a more reliable and valid endoscopic scoring system for clinical practice and outcomes research in CRS.
Study goals and objectives
- Assess the test-retest and inter-rater reliability of the AJESS and MLK scores.
- Assess the correlation of AJESS and MLK scores with cross-sectional PROMs (SNOT-22, VAS) and Sniffin' Sticks TDI Score
- Assess the reactivity of AJESS and MLK scores with prospective PROMs (SNOT-22, VAS) in patients experiencing CRS exacerbations
Research design
Participants visiting St. Paul's Sinus Centre who meet inclusion criteria and no exclusion criteria who are stable (N=100) and who are experiencing an exacerbation (N=30) will be approached at random and consented to the study. Encounters are expected to be 30 minutes each and participants experiencing a CRS or AFRS exacerbation will be expected to present for follow-up after 3 weeks (+/- 1 week) intervals for a second and a third encounter until their exacerbation are settled. The first encounter will collect relevant clinical data, endoscopic photos of 10 anatomic sites, patient-reported outcomes measures (PROMs, eg.SNOT-22, VAS) and olfactory sense test results (Sniffin' Sticks TDI score). Subsequent visits for exacerbated participants will collect the same endoscopic photos, PROMs and olfactory sense test results.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- AJESS scoring process
- Keywords
- Chronic Rhinosinusitis, Endoscopic score
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AJESS scoring processOther
We will collecto endoscopic pictures from stable and non stable participants. Pictures will be taken for each sinus, olfactory cleft, and middle meatus in private clinical exam rooms. For each anatomic site [left middle meatus (LMM), left ethmoid sinus (LES), left frontal sinus (LFS), left maxillary sinus (LMS), left olfactory cleft (LOC), left sphenoid sinus (LSS), right middle meatus (RMM), right ethmoid sinus (RES), right frontal sinus (RFS), right maxillary sinus (RMS), right olfactory cleft (ROC), right sphenoid sinus (RSS)], numerical scores describe edema or polyposis while alphabetical scores, in lower case or upper case corresponding to severity, describe CRS features: crusting, synechiae, purulence, mucus, recirculation, and ostial narrowness.
| Study group | Role | What they receive |
|---|---|---|
| Stable CRS | Experimental | Patients diagnosed with Chronic Rhinosinusitis including those with or without nasal polyposis and/or with Allergic Fungal Rhinosinusitis and stable condition Receives: Other: AJESS scoring process |
| Non-stable CRS | Experimental | Patients diagnosed with Chronic Rhinosinusitis including those with or without nasal polyposis and with Allergic Fungal Rhinosinusitis who are experiencing an exacerbation Receives: Other: AJESS scoring process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest and inter-rater reliability of the AJESS compare to MLK scores.
Measured: Baseline
Secondary outcomes (3)
Change in the SNOT-22 between the AJESS and MLK in stable participants
The Sinonasal Outcome Test includes 22 questions about symptoms and social/emotional consequences of participant's nasal disorder. Participants will be asked to rate their problems as they have been over the past two weeks. A score will be given out of 110 where a higher score indicates a worse outcome.
Measured: Baseline
Change in the VAS between the AJESS and MLK score in stable participants
Pain and discomfort (Visual Analog Scale): The visual analog score describes subjective pain and discomfort levels experienced by the participant about the sinus disease overall The scoring would be from 0 or No At All Severe/Doesn't Bother me at All to 10 Extremely Severe/ Bothers me very much
Measured: Baseline
Change in the Sniffin' Stick TDI between the AJESS and MLK score in stable participants
Sniffn' Sticks is a type of test to assess your sense of smell by using various scented pens. The threshold and identification tests will be performed. A score will be given out of 32 with a lower score indicating a worse outcome/sense of smell.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This mixed-methods clinical study of patients with CRS includes both a cross-sectional arm (single participant encounter with stable patients, n=100) and a second prospective aspect (3 participant encounters with patients experiencing CRS exacerbation, n=30)
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Javer, St. Paul's Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514120
- Sponsor's protocol ID
- H20-02108
- Acronym
- AJESS
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Descriptive and Clinically Relevant Postoperative Endoscopic Sinus Scoring System
- ClinicalTrials.gov ID
- NCT04514120
- Acronym / sponsor ID
- AJESS / H20-02108
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- Chronic Rhinosinusitis, Endoscopic score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 14 Aug 2020 (actual)
- 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.
Several endoscopic scores have been developed to assess Chronic Rhinosinusitis severity like the Modified Lund-Kennedy (MLK). This is a simple score only based on endoscopic signs. We proposed a more descriptive Alsaleh-Javer Endoscopic Sinus Score (AJESS) system which assesses all sinuses and nasal passages based on participant's severity of symptoms too. This would be a more reliable and clinically valid CRS endoscopic score. We aim to study thE AJESS system in 100 participants with stable CRS and 30 participants CRS who are experiencing an exacerbation (worsening of CRS).
Detailed description
Chronic rhinosinusitis (CRS) is a prevalent inflammatory disorder of the nasal passages and sinuses associated with detrimental effects on quality of life and productivity as well as billions of dollars in healthcare expenses and lost productivity each year. Numerous endoscopic scoring systems have been developed to assess CRS disease severity such as the popular Modified Lund-Kennedy (MLK) score which assesses sinus cavities only based on 3 criteria (polyps, edema, and discharge) with small 0-2 integer scales. Yet, such systems at best have reported good to moderate reliabilities and weak to no correlation with patient-reported outcome measures (PROMs) which should motivate further research to develop a more reliable and clinically valid CRS endoscopic scoring system, especially one which can better align the observed endoscopic signs of disease with the severity of symptoms reported by patients. In this study we propose a more descriptive Alsaleh-Javer Endoscopic Sinus Score (AJESS) system which assesses all sinuses and nasal passages with a numerical score of inflammation severity, alphabetical score for presence of CRS features, and an aggregated numerical score of overall disease severity. Our mixed-methods clinical study of 100 stable post-operative CRS patients and 30 post-operative CRS patients experiencing an exacerbation who are visiting St. Paul's Sinus Centre will gather both cross-sectional (1 visit, CRS stable) and prospective (2 follow-up visits approximately 2-4 weeks apart each, CRS flares) clinical data including two PROMs (SNOT-22, VAS) and an objective olfactory sensation test (Sniffin' Sticks TDI Score) to assess AJESS and MLK scores in terms of inter-rater reliability, test-retest reliability, correlation with clinical data, and responsiveness to changes in clinical data. Pending validation and head-to-head analysis with the MLK score, the AJESS system may be a more reliable and valid endoscopic scoring system for clinical practice and outcomes research in CRS.
Study goals and objectives
- Assess the test-retest and inter-rater reliability of the AJESS and MLK scores.
- Assess the correlation of AJESS and MLK scores with cross-sectional PROMs (SNOT-22, VAS) and Sniffin' Sticks TDI Score
- Assess the reactivity of AJESS and MLK scores with prospective PROMs (SNOT-22, VAS) in patients experiencing CRS exacerbations
Research design
Participants visiting St. Paul's Sinus Centre who meet inclusion criteria and no exclusion criteria who are stable (N=100) and who are experiencing an exacerbation (N=30) will be approached at random and consented to the study. Encounters are expected to be 30 minutes each and participants experiencing a CRS or AFRS exacerbation will be expected to present for follow-up after 3 weeks (+/- 1 week) intervals for a second and a third encounter until their exacerbation are settled. The first encounter will collect relevant clinical data, endoscopic photos of 10 anatomic sites, patient-reported outcomes measures (PROMs, eg.SNOT-22, VAS) and olfactory sense test results (Sniffin' Sticks TDI score). Subsequent visits for exacerbated participants will collect the same endoscopic photos, PROMs and olfactory sense test results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This mixed-methods clinical study of patients with CRS includes both a cross-sectional arm (single participant encounter with stable patients, n=100) and a second prospective aspect (3 participant encounters with patients experiencing CRS exacerbation, n=30)
| Arm | Type | Receives |
|---|---|---|
| Stable CRS | Experimental | Other: AJESS scoring processPatients diagnosed with Chronic Rhinosinusitis including those with or without nasal polyposis and/or with Allergic Fungal Rhinosinusitis and stable condition |
| Non-stable CRS | Experimental | Other: AJESS scoring processPatients diagnosed with Chronic Rhinosinusitis including those with or without nasal polyposis and with Allergic Fungal Rhinosinusitis who are experiencing an exacerbation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are over 19 years old
- Patients diagnosed with Chronic Rhinosinusitis including those with or without nasal polyposis and with Allergic Fungal Rhinosinusitis
- Post-operative patients
Key exclusion criteria (2 listed)
- Have a sinonasal neoplasm
- Have syndromic sinusitis e.g. cystic fibrosis or vasculitis
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 |
|---|---|---|
| AJESS scoring processWe will collecto endoscopic pictures from stable and non stable participants. Pictures will be taken for each sinus, olfactory cleft, and middle meatus in private clinical exam rooms. For each anatomic site [left middle meatus (LMM), left ethmoid sinus (LES), left frontal sinus (LFS), left maxillary sinus (LMS), left olfactory cleft (LOC), left sphenoid sinus (LSS), right middle meatus (RMM), right ethmoid sinus (RES), right frontal sinus (RFS), right maxillary sinus (RMS), right olfactory cleft (ROC), right sphenoid sinus (RSS)], numerical scores describe edema or polyposis while alphabetical scores, in lower case or upper case corresponding to severity, describe CRS features: crusting, synechiae, purulence, mucus, recirculation, and ostial narrowness. | Other | Non-stable CRS, Stable CRS |
Primary outcome
Test-retest and inter-rater reliability of the AJESS compare to MLK scores.
Time frame: Baseline
3 secondary outcomes
Change in the SNOT-22 between the AJESS and MLK in stable participants
Time frame: Baseline
Change in the VAS between the AJESS and MLK score in stable participants
Time frame: Baseline
Change in the Sniffin' Stick TDI between the AJESS and MLK score in stable participants
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing AJESS scoring process in people with Chronic Rhinosinusitis (Diagnosis), run by St. Paul's Hospital, 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 3 inclusion and 2 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 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Atenea Pascual ((604) 806-9926, apascual@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-retest and inter-rater reliability of the AJESS compare to MLK scores. (time frame: Baseline). 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 14 Aug 2020; AzTrials last refreshed its copy on 3 Nov 2026.