Chronic RhinitisNCT06682676
Diagnostic Efficacy of CDA Nasal Provocation Test in Patients With IR
A study testing Nasal ventilation function test and cold and dry air nasal provocation test in people with Chronic Rhinitis, run by The First Affiliated Hospital with Nanjing Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinitis
- What is being tested?
- Nasal ventilation function test and cold and dry air nasal provocation test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 7 Nov 2024to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: To Study the Diagnostic Efficacy of Cold Dry Air (CDA) Nasal Provocation Test in Patients With Idiopathic Rhinitis (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.
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.
- Conditions
- Chronic Rhinitis
- Being tested
- Nasal ventilation function test and cold and dry air nasal provocation test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal ventilation function test and cold and dry air nasal provocation testDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| chronic rhinitis | Experimental | 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 Receives: Device: Nasal ventilation function test and cold and dry air nasal provocation test |
| Healthy Volunteers | Experimental | 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 Receives: Device: Nasal ventilation function test and cold and dry air nasal provocation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20min
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
Measured: 20min
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.
Measured: 20min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start7 Nov 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinitisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Lei, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Lei Cheng, PhD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682676
- Sponsor's protocol ID
- 2024-SR-581
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the individual participant data only available to reasearchers participated in this study
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Diagnostic Efficacy of Cold Dry Air (CDA) Nasal Provocation Test in Patients With Idiopathic Rhinitis (IR)
- ClinicalTrials.gov ID
- NCT06682676
- Acronym / sponsor ID
- 2024-SR-581
- Conditions
- Chronic Rhinitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 7 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic rhinitis | Experimental | Device: Nasal ventilation function test and cold and dry air nasal provocation testNasal 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 |
| Healthy Volunteers | Experimental | Device: Nasal ventilation function test and cold and dry air nasal provocation testNasal 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal ventilation function test and cold and dry air nasal provocation testThe 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. | Device | Healthy Volunteers, chronic rhinitis |
Primary outcome
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No. All the individual participant data only available to reasearchers participated in this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Cheng, PhD principal investigator
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Nasal ventilation function test and cold and dry air nasal provocation test in people with Chronic Rhinitis, run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Cheng, PhD (+8613776620807, chenglei@jsph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhinoconjunctivitis Quality of Life Questionnaire (time frame: 20min). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.