Chronic RhinitisNCT06999044
Study on the Optimization of the Diagnostic Process for Chronic Rhinitis Using Nasal Allergen Provocation Test
An observational study of Chronic Rhinitis, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Chronic rhinitis (CR) is one of the most prevalent global diseases, with studies estimating that up to 30% of the worldwide population is affected. In China, the prevalence of chronic rhinitis ranges from 10% to 40%, impacting over 300 million individuals. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinitis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2025to 1 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1.Aged 18-75 years; 2. patients who visited the Department of Otorhinolaryngology,the First Affiliated Hospital of Nanjing Medical Uncversity and were willing to undergo nasal provocation test; 3.Ptients who are willing to provide specimens for free to promote the study of the diagnostic efficacy of nasal provocation.
Who may be able to join
- AR patients:
- Aged 18-75 years;
- patients who visited the Department of Otorhinolaryngology,the First Affiliated Hospital of Nanjing Medical Uncversity and were willing to undergo nasal provocation test; 3.Ptients who are willing to provide specimens for free to promote the study of the diagnostic efficacy of nasal provocation.
- Healthy volunteers:
- Aged 18-75 years;
- Did not have any nasal symptoms and tested negative for allergens
Who cannot join
- Acute rhinosinusitis or acute exacerbation of chronic rhinosinusitis; active phase or symptom exacerbation of allergic diseases (e.g., allergic rhinitis, asthma).
- History of severe allergic reactions (e.g., anaphylaxis).
- Severe chronic obstructive pulmonary disease (COPD) or severe cardiopulmonary diseases contraindicating epinephrine use.
- Active phase of other severe systemic diseases (e.g., malignancies, autoimmune diseases).
- Within 1 week post-vaccination.
- Pregnancy, lactation, or preconception period.
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- Inability to comply with study procedures (particularly children under 5 years old).
- Recent nasal surgery (within 2 months), nasal deformities (e.g., choanal atresia, severe nasal septum deviation/perforation), dry/atrophic rhinitis, severe nasal obstruction (e.g., hypertrophic rhinitis, rhinitis medicamentosa), or uncontrolled epistaxis.
- Current use of anti-allergy medications, including:Intranasal agents: corticosteroids, antihistamines, decongestants, anticholinergics, sodium cromoglicate;Systemic agents: oral antihistamines, oral/injectable corticosteroids.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ye Yuan, MBBS contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Lei Cheng, PhD, +8613776620807, chenglei@jsph.org.cn
Ye Yuan, MBBS, +8618244420200
About this study
Chronic rhinitis (CR) is one of the most prevalent global diseases, with studies estimating that up to 30% of the worldwide population is affected. In China, the prevalence of chronic rhinitis ranges from 10% to 40%, impacting over 300 million individuals. Although non-fatal, CR significantly disrupts daily work and academic performance, predisposes patients to respiratory comorbidities such as nasal polyps and asthma, and may induce systemic complications (e.g., secretory otitis media). Additionally, it detrimentally affects mental health, contributing to psychological disorders, substantial healthcare expenditures, and socioeconomic burdens.
Clinically, CR is broadly classified into allergic rhinitis (AR) and non-allergic rhinitis (NAR) based on skin prick test (SPT) and/or serum-specific IgE results. However, real-world clinical complexity arises as a subset of patients exhibit AR symptoms despite negative test results (local allergic rhinitis), while others with confirmed AR evade detection via conventional methods. This challenges the traditional dichotomous classification, highlighting its growing inadequacy. Given divergent therapeutic strategies for CR subtypes, ambiguous classification frequently leads to ineffective clinical outcomes, necessitating a gold-standard diagnostic framework for precise phenotyping.
The nasal allergen provocation test (NAPT), internationally recognized as the diagnostic gold standard for AR and local allergic rhinitis, directly applies allergens to nasal mucosa to elicit or exacerbate symptoms. Endorsed by global guidelines (e.g., ARIA, EPOS), NAPT has demonstrated safety through over a decade of clinical refinement. Despite its advantages, current protocols involve multi-dose allergen challenges at varying concentrations, rendering the procedure time-prohibitive and limiting clinical adoption. Developing a simplified, standardized provocation method is an urgent unmet need to expedite practical application.
- Conditions
- Chronic Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chronic rhinitis | The examination room temperature was maintained at 20-22°C, with patients acclimatizing to the testing environment for 15-30 minutes prior to evaluation. Baseline assessments included 4-phase rhinomanometry (4PR) and subjective symptom evaluation using a visual analogue scale (VAS) and total nasal symptom scores (TNSS). A reagent devoid of dust mite allergen was applied to the mucosa above the inferior nasal turbinate (middle meatus side) or the medial surface. After a 15-minute observation period, the test was terminated if a positive reaction occurred. If no positive reaction was observed, formal graded-concentration testing commenced. Starting with the predefined lowest concentration, patients were monitored for 15 minutes. A positive reaction prompted immediate termination of the test, followed by nasal secretion collection, reassessment of subjective/objective parameters, data recording, and administration of sychallenge protocols and ARIA guideline criteria for symptom scoring. | |
| Healthy Volunteers | The examination room temperature was maintained at 20-22°C, with patients acclimatizing to the testing environment for 15-30 minutes prior to evaluation. Baseline assessments included 4-phase rhinomanometry (4PR) and subjective symptom evaluation using a visual analogue scale (VAS) and total nasal symptom scores (TNSS). A reagent devoid of dust mite allergen was applied to the mucosa above the inferior nasal turbinate (middle meatus side) or the medial surface. After a 15-minute observation period, the test was terminated if a positive reaction occurred. If no positive reaction was observed, formal graded-concentration testing commenced. Starting with the predefined lowest concentration, patients were monitored for 15 minutes. A positive reaction prompted immediate termination of the test, followed by nasal secretion collection, reassessment of subjective/objective parameters, data recording, and administration of symptomatic relief medication. Absence of reactivity triggered progres |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale for nasal symptoms
Patients are scored by questionnaire before and after treatment, and the change in score before and after treatment is the primary outcome measure ,the value of the total scores change from 0 point to 40, higher scores mean a comparatively more positive outcome, which means the patient has a more severe symptoms.
Measured: The questionnaire should be done within 15 minutes after the nasal provocation test.
total nasal symptom scores
Patients are scored by questionnaire before and after treatment, and the change in score before and after treatment is the primary outcome measure ,the value of the total scores change from 0 point to 12, higher scores mean a comparatively more positive outcome, which means the patient has a more severe symptoms.
Measured: The questionnaire should be done within 15 minutes after the nasal provocation test.
4-phase rhinomanometry (4PR) measurements of nasal resistance
To measure the nasal resistance changes at 150Pa before and after the nasal provocation tests.
Measured: The measurements should be done within 15 minutes after the nasal provocation test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start24 Mar 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Cheng, PhD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999044
- Sponsor's protocol ID
- 2024-SR-1114
- Status last verified
- May 2025
- First submitted
- 7 Apr 2025
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the individual participant data only available to reasearchers participated in this study
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Optimization of the Diagnostic Process for Chronic Rhinitis Using Nasal Allergen Provocation Test
- ClinicalTrials.gov ID
- NCT06999044
- Acronym / sponsor ID
- 2024-SR-1114
- Conditions
- Chronic Rhinitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 31 May 2025 (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.
Chronic rhinitis (CR) is one of the most prevalent global diseases, with studies estimating that up to 30% of the worldwide population is affected. In China, the prevalence of chronic rhinitis ranges from 10% to 40%, impacting over 300 million individuals. Although non-fatal, CR significantly disrupts daily work and academic performance, predisposes patients to respiratory comorbidities such as nasal polyps and asthma, and may induce systemic complications (e.g., secretory otitis media). Additionally, it detrimentally affects mental health, contributing to psychological disorders, substantial healthcare expenditures, and socioeconomic burdens.
Clinically, CR is broadly classified into allergic rhinitis (AR) and non-allergic rhinitis (NAR) based on skin prick test (SPT) and/or serum-specific IgE results. However, real-world clinical complexity arises as a subset of patients exhibit AR symptoms despite negative test results (local allergic rhinitis), while others with confirmed AR evade detection via conventional methods. This challenges the traditional dichotomous classification, highlighting its growing inadequacy. Given divergent therapeutic strategies for CR subtypes, ambiguous classification frequently leads to ineffective clinical outcomes, necessitating a gold-standard diagnostic framework for precise phenotyping.
The nasal allergen provocation test (NAPT), internationally recognized as the diagnostic gold standard for AR and local allergic rhinitis, directly applies allergens to nasal mucosa to elicit or exacerbate symptoms. Endorsed by global guidelines (e.g., ARIA, EPOS), NAPT has demonstrated safety through over a decade of clinical refinement. Despite its advantages, current protocols involve multi-dose allergen challenges at varying concentrations, rendering the procedure time-prohibitive and limiting clinical adoption. Developing a simplified, standardized provocation method is an urgent unmet need to expedite practical application.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic rhinitis | – | –The examination room temperature was maintained at 20-22°C, with patients acclimatizing to the testing environment for 15-30 minutes prior to evaluation. Baseline assessments included 4-phase rhinomanometry (4PR) and subjective symptom evaluation using a visual analogue scale (VAS) and total nasal symptom scores (TNSS). A reagent devoid of dust mite allergen was applied to the mucosa above the inferior nasal turbinate (middle meatus side) or the medial surface. After a 15-minute observation period, the test was terminated if a positive reaction occurred. If no positive reaction was observed, formal graded-concentration testing commenced. Starting with the predefined lowest concentration, patients were monitored for 15 minutes. A positive reaction prompted immediate termination of the test, followed by nasal secretion collection, reassessment of subjective/objective parameters, data recording, and administration of sychallenge protocols and ARIA guideline criteria for symptom scoring. |
| Healthy Volunteers | – | –The examination room temperature was maintained at 20-22°C, with patients acclimatizing to the testing environment for 15-30 minutes prior to evaluation. Baseline assessments included 4-phase rhinomanometry (4PR) and subjective symptom evaluation using a visual analogue scale (VAS) and total nasal symptom scores (TNSS). A reagent devoid of dust mite allergen was applied to the mucosa above the inferior nasal turbinate (middle meatus side) or the medial surface. After a 15-minute observation period, the test was terminated if a positive reaction occurred. If no positive reaction was observed, formal graded-concentration testing commenced. Starting with the predefined lowest concentration, patients were monitored for 15 minutes. A positive reaction prompted immediate termination of the test, followed by nasal secretion collection, reassessment of subjective/objective parameters, data recording, and administration of symptomatic relief medication. Absence of reactivity triggered progres |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1.Aged 18-75 years; 2. patients who visited the Department of Otorhinolaryngology,the First Affiliated Hospital of Nanjing Medical Uncversity and were willing to undergo nasal provocation test; 3.Ptients who are willing to provide specimens for free to promote the study of the diagnostic efficacy of nasal provocation.
Key inclusion criteria (6 listed)
- Aged 18-75 years;
- patients who visited the Department of Otorhinolaryngology,the First Affiliated Hospital of Nanjing Medical Uncversity and were willing to undergo nasal provocation test; 3.Ptients who are willing to provide specimens for free to promote the study of the diagnostic efficacy of nasal provocation.
- Aged 18-75 years;
- Did not have any nasal symptoms and tested negative for allergens
Key exclusion criteria (9 listed)
- Acute rhinosinusitis or acute exacerbation of chronic rhinosinusitis; active phase or symptom exacerbation of allergic diseases (e.g., allergic rhinitis, asthma).
- History of severe allergic reactions (e.g., anaphylaxis).
- Severe chronic obstructive pulmonary disease (COPD) or severe cardiopulmonary diseases contraindicating epinephrine use.
- Active phase of other severe systemic diseases (e.g., malignancies, autoimmune diseases).
- Within 1 week post-vaccination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
visual analogue scale for nasal symptoms
Time frame: The questionnaire should be done within 15 minutes after the nasal provocation test.
Patients are scored by questionnaire before and after treatment, and the change in score before and after treatment is the primary outcome measure ,the value of the total scores change from 0 point to 40, higher scores mean a comparatively more positive outcome, which means the patient has a more severe symptoms.
total nasal symptom scores
Time frame: The questionnaire should be done within 15 minutes after the nasal provocation test.
Patients are scored by questionnaire before and after treatment, and the change in score before and after treatment is the primary outcome measure ,the value of the total scores change from 0 point to 12, higher scores mean a comparatively more positive outcome, which means the patient has a more severe symptoms.
4-phase rhinomanometry (4PR) measurements of nasal resistance
Time frame: The measurements should be done within 15 minutes after the nasal provocation test.
To measure the nasal resistance changes at 150Pa before and after the nasal provocation tests.
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 31 May 2025.
- Individual participant dataSharing planned: No. All the individual participant data only available to reasearchers participated in this study
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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.
Ye Yuan, MBBS contact
Lei Cheng, PhD principal investigator
The First Affiliated Hospital with Nanjing Medical University
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 Chronic Rhinitis, run by The First Affiliated Hospital with Nanjing Medical University 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 31 May 2025. 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 Lei Cheng, PhD (+8613776620807, chenglei@jsph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale for nasal symptoms (time frame: The questionnaire should be done within 15 minutes after the nasal provocation test.). The study lists 3 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 31 May 2025.