NCT06999044 Study on the Optimization of the Diagnostic Process for Chronic Rhinitis Using Nasal Allergen Provocation Test
| NCT ID | NCT06999044 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Chronic Rhinitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-03-24 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-03-24 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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. * 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.
Contact & Investigator
Lei Cheng, PhD
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT06999044 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Rhinitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06999044 currently recruiting?
Yes, NCT06999044 is actively recruiting participants. Contact the research team at chenglei@jsph.org.cn for enrollment information.
Where is the NCT06999044 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06999044 clinical trial?
NCT06999044 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is Lei Cheng, PhD at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 100 participants.