Actively Recruiting
Study on the Optimization of the Diagnostic Process for Chronic Rhinitis Using Nasal Allergen Provocation Test
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-05-31
100
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study on the Optimization of the Diagnostic Process for Chronic Rhinitis Using Nasal Allergen Provocation Test
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years
- Allergic rhinitis patients willing to undergo nasal provocation test at the specified hospital
- Willing to provide specimens to support the study
- Healthy volunteers aged 18 to 75 years with no nasal symptoms and negative allergen tests
You will not qualify if you...
- Acute rhinosinusitis or flare-up of chronic rhinosinusitis
- Active allergic diseases like allergic rhinitis or asthma
- History of severe allergic reactions such as anaphylaxis
- Severe COPD or cardiopulmonary diseases that prevent epinephrine use
- Active severe systemic diseases like cancer or autoimmune disorders
- Vaccination within the past week
- Pregnancy, lactation, or preconception period
- Inability to follow study procedures, especially children under 5 years
- Recent nasal surgery within 2 months or structural nasal problems
- Dry or atrophic rhinitis, severe nasal blockage, or uncontrolled nosebleeds
- Current use of anti-allergy medications including nasal and systemic corticosteroids and antihistamines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
L
Lei Cheng, PhD
CONTACT
Y
Ye Yuan, MBBS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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