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NCT Number: NCT06682676

Diagnostic Efficacy of CDA Nasal Provocation Test in Patients With IR

Chronic rhinitis is a common chronic nasal mucosal inflammatory disease. Its clinical symptoms and severity are diverse, mainly including allergic rhinitis, local allergic rhinitis, non-allergic rhinitis with hypereosinophilia syndrome and idiopathic rhinitis. All kinds of rhinitis have clinical symptoms such as nasal congestion, runny nose, sneezing, and nasal itching, but the causes are different. At present, the diagnosis of idiopathic rhinitis (IR) is based on detailed medical history and negative allergen test results, which is a diagnosis of exclusion. According to the position paper of the European Academy of Allergy and Clinical Immunology (EAACI), nasal hyperresponsiveness is an abnormal reaction of the nasal mucosa to stimuli that most people can tolerate. One of the distinguishing features of non-allergic rhinitis. cold dry air (CDA) nasal provocation test has been proved to be a good, safe and tolerable test for nasal hyperresponsiveness, with superior sensitivity and specificity. At present, there is still a lack of clear diagnostic criteria for IR. Therefore, optimizing CDA nasal provocation test, determining the diagnostic efficacy of CDA nasal provocation test with different parameters for IR, and initially constructing an IR diagnostic model can provide more comprehensive guidance for clinical diagnosis and treatment, which has important clinical significance.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The visual analogue scale (VAS) of nasal symptoms, rhinoconjunctivitis quality of life questionnaire (RQLQ), total nasal symptom score (TNSS), total nasal volume (TNV), minimum cross-sectional area (MCA), peak inspiratory flow (PNIF), and total nasal resistance (TNR) at 75Pa were recorded before and after nasal ventilation function test and CDA nasal provocation test.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • IR patients: 1. Aged 18-65 years; 2. The presence of symptoms of rhinitis for more than 2 years, often triggered by non-specific stimuli, serum and nasal secretion allergen specific IgE test negative, nasal endoscopy examination ruled out severe anatomical disease and sinusitis with or without polyps, nasal secretion smear no eosinophils, allergic rhinitis, local allergic rhinitis, eosinophilia non-allergic rhinitis were excluded; 3. IR patients who visited the Department of Otorhinolaryngology, the First Affiliated Hospital of Nanjing Medical University and were willing to undergo CDA nasal provocation test; 4.Ptients who are willing to provide specimens for free to promote the study of the diagnostic efficacy of CDA nasal provocation test for IR.
  • Healthy volunteers: 1. Aged 18-65 years; 2. Did not have any nasal symptoms and tested negative for allergens.

Exclusion criteria

  • 1. Patients received glucocorticoids, immunomodulatory drugs, antihistamines, and other treatments that may affect the study results within the past 1 month. 2. Patients with unstable diseases (including severe asthma) and active immune system diseases; 3. Smoking; 4. Pregnant or lactating women; History of nasal surgery within 5.3 months; 6. Patients with any nasal conditions that may interfere with the efficacy or safety evaluation of CDA nasal provocation test; 7. Patients with low compliance and refusing to accept specimen and questionnaire collection.

Treatment and study plan

Nasal ventilation function test and cold and dry air nasal provocation test

Device

The visual analogue scale (VAS) of nasal symptoms, rhinoconjunctivitis quality of life questionnaire (RQLQ), total nasal symptom score (TNSS), total nasal volume (TNV), minimum cross-sectional area (MCA), peak inspiratory flow (PNIF), and total nasal resistance (TNR) at 75Pa were recorded before and after nasal ventilation function test and CDA nasal provocation test.

Primary outcomes

  1. Rhinoconjunctivitis Quality of Life Questionnaire

    Time frame: 20min

    Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure

  2. Visual Analog Score for pain

    Time frame: 20min

    Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure

  3. Total nasal volume, minimum cross-sectional area, and total nasal resistance at 75Pa

    Time frame: 20min

    The total volume of nasal cavity, the minimum cross-sectional area and the total nasal resistance at 75Pa were recorded by acoustic rhinometer and rhinomanometer. The total nasal resistance was calculated by Rt=Rl*Rr/(Rl+Rr), Rt was the total nasal resistance, Rl and Rr represented the left and right nasal resistance respectively.

Study contacts

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

Lei Cheng, PhD

CONTACT

[email protected]

+8613776620807

Yanbing Chen, MBBS

CONTACT

[email protected]

+8615851875990

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

To Study the Diagnostic Efficacy of Cold Dry Air (CDA) Nasal Provocation Test in Patients With Idiopathic Rhinitis (IR)

Important dates

Study start
2024
Primary completion
2027
Study completion
2032
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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