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

NCT06999044 | Recruiting

• 1 other identifier: 2024-SR-1114
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinitis

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

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

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

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

Study Arms (2)

chronic rhinitis

The examination room temperature was maintained at 20-22°C, with patients acclimatizing to the testing environment for 15-30 minutes prior to evaluation. Baseline assessments included 4-phase rhinomanometry (4PR) and subjective symptom evaluation using a visual analogue scale (VAS) and total nasal symptom scores (TNSS). A reagent devoid of dust mite allergen was applied to the mucosa above the inferior nasal turbinate (middle meatus side) or the medial surface. After a 15-minute observation period, the test was terminated if a positive reaction occurred. If no positive reaction was observed, formal graded-concentration testing commenced. Starting with the predefined lowest concentration, patients were monitored for 15 minutes. A positive reaction prompted immediate termination of the test, followed by nasal secretion collection, reassessment of subjective/objective parameters, data recording, and administration of sychallenge protocols and ARIA guideline criteria for symptom scoring.

Healthy Volunteers

The examination room temperature was maintained at 20-22°C, with patients acclimatizing to the testing environment for 15-30 minutes prior to evaluation. Baseline assessments included 4-phase rhinomanometry (4PR) and subjective symptom evaluation using a visual analogue scale (VAS) and total nasal symptom scores (TNSS). A reagent devoid of dust mite allergen was applied to the mucosa above the inferior nasal turbinate (middle meatus side) or the medial surface. After a 15-minute observation period, the test was terminated if a positive reaction occurred. If no positive reaction was observed, formal graded-concentration testing commenced. Starting with the predefined lowest concentration, patients were monitored for 15 minutes. A positive reaction prompted immediate termination of the test, followed by nasal secretion collection, reassessment of subjective/objective parameters, data recording, and administration of symptomatic relief medication. Absence of reactivity triggered progres

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Study Officials

• Lei Cheng, PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Cheng, PhD

CONTACT

+8613776620807; chenglei@jsph.org.cn

Ye Yuan, MBBS

CONTACT

+8618244420200

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 31, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)