Optimizing diagnosis of chronic rhinitis with a nasal allergen provocation test
Study on the Optimization of the Diagnostic Process for Chronic Rhinitis Using Nasal Allergen Provocation Test
This project will test whether a nasal allergen provocation test helps diagnose adults with chronic rhinitis by comparing patients with suspected allergic rhinitis to healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06999044 on ClinicalTrials.gov |
What this trial studies
This observational study at The First Affiliated Hospital of Nanjing Medical University enrolls adults aged 18–75 with suspected allergic rhinitis and healthy volunteers who test negative for allergens. Participants will undergo a nasal allergen provocation test and provide specimens to examine diagnostic patterns, including cases of local allergic rhinitis. Exclusion criteria include acute rhinosinusitis, severe cardiopulmonary disease, recent vaccination, pregnancy or lactation, and history of severe allergic reactions. The aim is to refine diagnostic workflows and improve identification of allergic versus non-allergic or local allergic rhinitis.
Who should consider this trial
Good fit: Adults 18–75 with suspected allergic rhinitis who are willing to undergo nasal provocation testing and provide specimens, as well as healthy volunteers without nasal symptoms, are ideal candidates.
Not a fit: People with acute rhinosinusitis, severe cardiopulmonary disease, recent vaccination, pregnancy or lactation, or a history of severe allergic reactions are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could make diagnosis more accurate so patients receive the right treatment sooner.
How similar studies have performed: Nasal allergen provocation testing has been used in prior research and shown diagnostic value for identifying local allergic rhinitis, so this study builds on existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Lei Cheng, PhD — The First Affiliated Hospital with Nanjing Medical University
- Study coordinator: Lei Cheng, PhD
- Email: chenglei@jsph.org.cn
- Phone: +8613776620807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.