Central Compartment Atopic Disease (CCAD)NCT07380945
Development of A Multi-section Olfactory Cleft Opacity Staging System in Patients With CCAD
An observational study of Central Compartment Atopic Disease (CCAD), run by Peking University Third Hospital at 1 site in China.
Trial summary
This study aims to develop a modified CT scoring system to evaluate the association between olfactory cleft obstruction patterns and olfactory dysfunction in patients with central region atopic disease (CCAD). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Compartment Atopic Disease (CCAD)
- What is being tested?
- Computer Tomography
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were recruited from the Department of Otolaryngology at Peking University Third Hospital in clinic.
Who may be able to join
- Diagnosed with CCAD based on the diagnostic criteria of the EPOS guideline.
- Provision of signed and dated informed consent form.
- Diagnosed with CRS (non-CCAD) based on the diagnostic criteria of the EPOS guideline.
- Provision of signed and dated informed consent form.
Who cannot join
- Those who have taken oral glucocorticoids, antibiotics, anti-leukotrienes, and antihistamines within four weeks.
- Patients who have had prior sinus surgery.
- Patients with fungal sinusitis, inverted papilloma, or other nasal diseases.
- Patients with a diagnosis of immune suppression or suspicion of malignancy that may be affecting the nose/paranasal sinuses.
- Patients who are mentally or physically unable to perform olfactory tests
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Otolaryngology Head and Neck Surgery, Peking University Third Hospital
Beijing, People's Republic of China, 10019
Dawei Wu, MD, PhD, +86-10-13522503401, davidwuorl@163.com
About this study
Official title: Development of A Multi-section Olfactory Cleft Opacity Staging System in Patients With Central Compartment Atopic Disease (CCAD)
This study aims to develop a modified CT scoring system to evaluate the association between olfactory cleft obstruction patterns and olfactory dysfunction in patients with central region atopic disease (CCAD).
The main questions that the clinical trial aims to answer are: Can this modified CT scoring system be used to assess the degree of olfactory impairment in patients with CCAD? How well does the modified CT score correlate with the patient's olfaction compared to the traditional CT score?
Read the detailed description
Olfactory dysfunction is one of the important clinical manifestations of patients with central compartment atopic disease (CCAD), whose pathological mechanism has not been fully elucidated. Previous studies have shown that physical blockage of Olfactory Cleft (OC) may block odor molecules from reaching the olfactory mucosa in the olfactory region.
At present, there is still a lack of systematic standards for imaging evaluation of olfactory obstruction patterns. Traditional CT scores are mostly based on the percentage of occlusion area in a single dimension, which is difficult to reflect the turbidity of the anterior and posterior OC. The anterior olfactory cleft serves as the main entrance to the odor molecules, and its apical and middle lower blockage may have different effects on olfactory conduction. Therefore, it is urgent to establish a regionally divided CT scoring system to more accurately analyze the spatial characteristics of olfactory cleft opacification in CCAD patients and its correlation with olfactory function.
This prospective study aims to develop an improved olfactory CT scores evaluation system to reveal the anatomical mechanism of olfactory dysfunction in patients with CCAD. All the participants (n=??) had undergone:
- Clinical assessment of olfactory function Using the Sniffin' Sticks Test to evaluate olfaction. The scores of the three tests of odor threshold (OT), odor discrimination (OD) and odor identification (OI) are added to the total TDI score. TDI with a total score of 48 points is normal for people >30.75 points, ≤30.75 is classified as olfactory disorder, among which 16-30 indicates hyposmia and <16 indicates anosmia. Patients are divided into three groups according to the TDI score.
- Traditional CT scores The olfactory cleft was considered to start at the anterior most olfactory filament (the anterior plane of middle turbinate) and end just anterior to the face of the sphenoid sinus. A computed tomography (CT) scan was performed to evaluate the OC opacification. The anterior end of the superior turbinate is boundary, and the OC is divided into two parts: anterior and posterior. The OC opacifications, in which the normal airway filled with a value representing soft tissue and /or presence of close contact between the nasal turbinates and the nasal septum, were graded on a scale of 0-4 by the ratio of the opacified area to the whole area of the corresponding region of the olfactory cleft, with 0 (no opacification), 1 (25%), 2 (25%-50%), 3 (50%-75%), and 4 (>75%).
- Modified olfactory cleft scores The scores of the independently assessed regions including the left anterior, left posterior, right anterior, and right posterior olfactory cleft are summed to obtain the anterior (left anterior and right anterior), posterior (left posterior and right posterior) , and total scores. Specifically, the opacification of each OC subregion is independently assessed, with a score of 1 if unilateral opacity is observed, 2 points for bilateral opacity, and 0 if none.
- Being tested
- Computer Tomography
- Keywords
- olfactory cleft, olfactory dysfuction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer TomographyOther
Also called collection of the percentage of peripheral blood eosinophils
low-dose CT is taken
| Study group | Role | What they receive |
|---|---|---|
| Patients with CCAD | Not described Receives: Other: Computer Tomography | |
| non-CCAD patients with chronic rhinosinusitis | Not described Receives: Other: Computer Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the novel olfactory cleft CT scoring system for imaging assessment in CCAD patients
Validation of the novel CT scoring system for superior characterization of olfactory cleft obstruction compared to the traditional CT scoring system.
Measured: Immediately after CT scans
Predictive performance of the novel olfactory cleft CT scoring system
Construct a predictive model for CCAD using logistic regression, incorporating both the novel CT score and peripheral blood eosinophil percentage, and compare it with the traditional olfactory cleft CT scoring system.
Measured: Immediately after CT scans
Secondary outcomes (2)
Correlation between novel olfactory cleft CT scores in different regions and CCAD diagnosis
Analyze the differences in scoring across various anatomical subregions in the CCAD group and identify the most diagnostically relevant regions.
Measured: Immediately after CT scans
Association between the novel olfactory cleft CT score, olfactory function, and eosinophil percentage
Investigate the relationship between the novel CT scoring system and olfactory dysfunction, as well as its potential to reflect Type 2 inflammation (eosinophilic activity).
Measured: Immediately after CT scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Compartment Atopic Disease (CCAD)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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawei Wu, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380945
- Sponsor's protocol ID
- 9059105
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will decide whether to share the individual participant data after the study.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of A Multi-section Olfactory Cleft Opacity Staging System in Patients With Central Compartment Atopic Disease (CCAD)
- ClinicalTrials.gov ID
- NCT07380945
- Acronym / sponsor ID
- 9059105
- Keywords
- olfactory cleft, olfactory dysfuction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Feb 2026 (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.
This study aims to develop a modified CT scoring system to evaluate the association between olfactory cleft obstruction patterns and olfactory dysfunction in patients with central region atopic disease (CCAD).
The main questions that the clinical trial aims to answer are: Can this modified CT scoring system be used to assess the degree of olfactory impairment in patients with CCAD? How well does the modified CT score correlate with the patient's olfaction compared to the traditional CT score?
Detailed description
Olfactory dysfunction is one of the important clinical manifestations of patients with central compartment atopic disease (CCAD), whose pathological mechanism has not been fully elucidated. Previous studies have shown that physical blockage of Olfactory Cleft (OC) may block odor molecules from reaching the olfactory mucosa in the olfactory region.
At present, there is still a lack of systematic standards for imaging evaluation of olfactory obstruction patterns. Traditional CT scores are mostly based on the percentage of occlusion area in a single dimension, which is difficult to reflect the turbidity of the anterior and posterior OC. The anterior olfactory cleft serves as the main entrance to the odor molecules, and its apical and middle lower blockage may have different effects on olfactory conduction. Therefore, it is urgent to establish a regionally divided CT scoring system to more accurately analyze the spatial characteristics of olfactory cleft opacification in CCAD patients and its correlation with olfactory function.
This prospective study aims to develop an improved olfactory CT scores evaluation system to reveal the anatomical mechanism of olfactory dysfunction in patients with CCAD. All the participants (n=??) had undergone:
- Clinical assessment of olfactory function Using the Sniffin' Sticks Test to evaluate olfaction. The scores of the three tests of odor threshold (OT), odor discrimination (OD) and odor identification (OI) are added to the total TDI score. TDI with a total score of 48 points is normal for people >30.75 points, ≤30.75 is classified as olfactory disorder, among which 16-30 indicates hyposmia and <16 indicates anosmia. Patients are divided into three groups according to the TDI score.
- Traditional CT scores The olfactory cleft was considered to start at the anterior most olfactory filament (the anterior plane of middle turbinate) and end just anterior to the face of the sphenoid sinus. A computed tomography (CT) scan was performed to evaluate the OC opacification. The anterior end of the superior turbinate is boundary, and the OC is divided into two parts: anterior and posterior. The OC opacifications, in which the normal airway filled with a value representing soft tissue and /or presence of close contact between the nasal turbinates and the nasal septum, were graded on a scale of 0-4 by the ratio of the opacified area to the whole area of the corresponding region of the olfactory cleft, with 0 (no opacification), 1 (25%), 2 (25%-50%), 3 (50%-75%), and 4 (>75%).
- Modified olfactory cleft scores The scores of the independently assessed regions including the left anterior, left posterior, right anterior, and right posterior olfactory cleft are summed to obtain the anterior (left anterior and right anterior), posterior (left posterior and right posterior) , and total scores. Specifically, the opacification of each OC subregion is independently assessed, with a score of 1 if unilateral opacity is observed, 2 points for bilateral opacity, and 0 if none.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with CCAD | – | Other: Computer Tomography |
| non-CCAD patients with chronic rhinosinusitis | – | Other: Computer Tomography |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from the Department of Otolaryngology at Peking University Third Hospital in clinic.
Key inclusion criteria (4 listed)
- Diagnosed with CCAD based on the diagnostic criteria of the EPOS guideline.
- Provision of signed and dated informed consent form.
- Diagnosed with CRS (non-CCAD) based on the diagnostic criteria of the EPOS guideline.
- Provision of signed and dated informed consent form.
Key exclusion criteria (5 listed)
- Those who have taken oral glucocorticoids, antibiotics, anti-leukotrienes, and antihistamines within four weeks.
- Patients who have had prior sinus surgery.
- Patients with fungal sinusitis, inverted papilloma, or other nasal diseases.
- Patients with a diagnosis of immune suppression or suspicion of malignancy that may be affecting the nose/paranasal sinuses.
- Patients who are mentally or physically unable to perform olfactory tests
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 |
|---|---|---|
| Computer TomographyAlso: collection of the percentage of peripheral blood eosinophilslow-dose CT is taken | Other | Patients with CCAD, non-CCAD patients with chronic rhinosinusitis |
Primary outcome
Evaluation of the novel olfactory cleft CT scoring system for imaging assessment in CCAD patients
Time frame: Immediately after CT scans
Validation of the novel CT scoring system for superior characterization of olfactory cleft obstruction compared to the traditional CT scoring system.
Predictive performance of the novel olfactory cleft CT scoring system
Time frame: Immediately after CT scans
Construct a predictive model for CCAD using logistic regression, incorporating both the novel CT score and peripheral blood eosinophil percentage, and compare it with the traditional olfactory cleft CT scoring system.
2 secondary outcomes
Correlation between novel olfactory cleft CT scores in different regions and CCAD diagnosis
Time frame: Immediately after CT scans
Association between the novel olfactory cleft CT score, olfactory function, and eosinophil percentage
Time frame: Immediately after CT scans
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No. We will decide whether to share the individual participant data after the study.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Compartment Atopic Disease (CCAD), run by Peking University Third Hospital at 1 site in China.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Feb 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dawei Wu, MD, PhD (+86-10-13522503401, davidwuorl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the novel olfactory cleft CT scoring system for imaging assessment in CCAD patients (time frame: Immediately after CT scans). The study lists 2 primary outcomes in all. 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 2 Feb 2026.