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NCT Number: NCT06999044

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

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.

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Key information

Conditions

Chronic Rhinitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location status: Recruiting

Location contact

Lei Cheng, PhD

CONTACT

[email protected]

+8613776620807

Lei Cheng, PhD

PRINCIPAL_INVESTIGATOR

Ye Yuan, MBBS

CONTACT

+8618244420200

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

visual analogue scale for nasal symptoms

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

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.
total nasal symptom scores

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

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Cheng, PhD

CONTACT

[email protected]

+8613776620807

Ye Yuan, MBBS

CONTACT

+8618244420200

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: May 31, 2025
Registry last updated: May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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