Study on the Optimization of the Diagnostic Process for Chronic Rhinitis Using Nasal Allergen Provocation Test

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: chronic rhinitis
Group B: Healthy Volunteers

Trial outcomes

Primary outcomes

1

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.

Time frame
The questionnaire should be done within 15 minutes after the nasal provocation test.
2

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.

Time frame
The questionnaire should be done within 15 minutes after the nasal provocation test.
3

4-phase rhinomanometry (4PR) measurements of nasal resistance

To measure the nasal resistance changes at 150Pa before and after the nasal provocation tests.

Time frame
The measurements should be done within 15 minutes after the nasal provocation test.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.