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Not yet recruitingNCT06682676Updated Nov 12, 2024

Diagnostic Efficacy of CDA Nasal Provocation Test in Patients With IR

An interventional study of Nasal ventilation function test and cold and dry air nasal provocation test in Chronic Rhinitis, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Chronic Rhinitis

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03

In context

Rhinitis

246 studies on the registry are indexed under Rhinitis; 22 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 187 interventional studies indexed under Rhinitis.

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Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

    1. Patients received , 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    chronic rhinitis

    Nasal ventilation tests were performed indoors at a temperature of (24±5) °C and a humidity of (70±10) %. Using acoustic rhinometry and rhinomanometry, total nasal volume, minimum cross-sectional area and total nasal resistance at 75Pa were recorded.Cold and dry air nasal provocation test usually requires nasal inhalation of 0°C-5°C, relative humidity \< 10% cold air at a flow rate of 26L/min. The nasal symptom rating questionnaire and visual analogue scale were completed before and after the CDA test

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

  • Experimental
    Healthy Volunteers

    Nasal ventilation tests were performed indoors at a temperature of (24±5) °C and a humidity of (70±10) %. Using acoustic rhinometry and rhinomanometry, total nasal volume, minimum cross-sectional area and total nasal resistance at 75Pa were recorded.Cold and dry air nasal provocation test usually requires nasal inhalation of 0°C-5°C, relative humidity \< 10% cold air at a flow rate of 26L/min. The nasal symptom rating questionnaire and visual analogue scale were completed before and after the CDA test

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

Interventions

  • DeviceNasal ventilation function test and cold and dry air nasal provocation test

    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.

06

What researchers measure

Primary outcomes

  1. Rhinoconjunctivitis Quality of Life Questionnaire

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

    Time frame: 20min

  2. Visual Analog Score for pain

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

    Time frame: 20min

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

    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.

    Time frame: 20min

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — All the individual participant data only available to reasearchers participated in this study

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06682676
Responsible party
Cheng Lei (Professor, PhD, The First Affiliated Hospital with Nanjing Medical University) — Principal investigator
First posted
Nov 12, 2024
Start date
Nov 7, 2024 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Nov 12, 2024

Study contacts

Lei Cheng, PhD
Contact
chenglei@jsph.org.cn
+8613776620807
Yanbing Chen, MBBS
Contact
jspent@126.com
+8615851875990
Lei Cheng, PhD
principal investigator · The First Affiliated Hospital with Nanjing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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