Optimizing diagnosis of chronic rhinitis with a nasal allergen provocation test
Official title: Study on the Optimization of the Diagnostic Process for Chronic Rhinitis Using Nasal Allergen Provocation Test
Run by The First Affiliated Hospital with Nanjing Medical University · NCT06999044 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | March 24, 2025 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2028 |
| Registry record updated | May 31, 2025 |
| Trial ID | NCT06999044 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this could make diagnosis more accurate so patients receive the right treatment sooner.
How similar studies have gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.