Combined Allergic Rhinitis and Asthma SyndromeNCT06573450
Exhaled Breath Condensate Biomarkers in CARAS
An observational study of Combined Allergic Rhinitis and Asthma Syndrome, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
To explore the differences in the expression of biomarkers in different sample types between the healthy population and different subgroups of the disease, and to screen for potential biomarkers in a more simple, direct and objective way. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Combined Allergic Rhinitis and Asthma Syndrome
- What is being tested?
- questionnaire survey
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Allergic rhinitis (AR) is a common chronic inflammatory disease of the upper respiratory tract with paroxysmal sneezing, nasal congestion, watery nasal discharge and nasal itching as the main clinical symptoms. Bronchial asthma (BA) is a complex heterogeneous chronic inflammatory disease of the bronchi with recurrent symptoms of wheezing, shortness of breath, chest tightness, and coughing.AR usually coexists with BA, and about 70-90% of patients with asthma develop rhinitis, and about 40% of patients with rhinitis develop asthma. When AR and BA occur together, it is called combined allergic rhinitis and asthma syndrome (CARAS).
Who may be able to join
- Patients with AR, BA and CARAS who meet the Western medical diagnostic criteria;
- Chinese medical evidence consistent with lung qi deficiency evidence, phlegm-heat congestion of the lung evidence, or wind-heat offending the lung evidence;
- Age 18 to 80 years;
- Voluntarily accepted the study and signed an informed consent form;
- Not participated in other clinical studies within 1 month before enrollment.
Who cannot join
- Patients with combined vasomotor rhinitis and eosinophilic non-allergic rhinitis, other non-allergic rhinitis diseases that can cause symptoms such as nasal congestion and runny nose;
- Patients who are participating in other drug trials;
- Patients with a combination of other serious systemic diseases;
- Pregnant or lactating women;
- Patients with confusion, disorders of consciousness, dementia, and various psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan University of Chinese Medicine
Henan, Zhengzhou
Yang Xie, Ph.D, +8613526621325, xieyanghn@163.com
About this study
Official title: Preliminary Application and Evaluation of Exhaled Breath Condensate Biomarkers in Combined Allergic Rhinitis and Asthma Syndrome (CARAS)
To explore the differences in the expression of biomarkers in different sample types between the healthy population and different subgroups of the disease, and to screen for potential biomarkers in a more simple, direct and objective way. To screen the biomarkers that can be identified by CARAS Chinese medicine symptoms and different stages, and to provide a reference basis for individualised diagnosis and treatment of the disease.
- Being tested
- questionnaire survey
- Keywords
- CARAS, EBC, Biomarkers, Combination of disease and evidence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire surveyOther
subjects fill out questionnaires
| Study group | Role | What they receive |
|---|---|---|
| acute exacerbation CARAS | Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. Receives: Other: questionnaire survey | |
| chronic persistence CARAS | Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. Receives: Other: questionnaire survey | |
| clinical control CARAS | Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. Receives: Other: questionnaire survey | |
| acute exacerbation BA | Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. Receives: Other: questionnaire survey | |
| chronic persistence BA | Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. Receives: Other: questionnaire survey | |
| clinical control BA | Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. Receives: Other: questionnaire survey | |
| intermittent AR | Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. Receives: Other: questionnaire survey | |
| persistent AR | Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. Receives: Other: questionnaire survey | |
| healthy individuals | Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. Receives: Other: questionnaire survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-2、4、5、13 (IL-2、4、5、13)
Airway inflammation will be assessed using the IL-2、4、5、13.
Measured: Basline
Interferon-γ (IFN-γ)
Airway inflammation will be assessed using the IFN-γ.
Measured: Basline
Tumor necrosis factor-β (TNF-β)
Airway inflammation will be assessed using the TNF-β.
Measured: Basline
Eosinophil cationic proteins (ECP)
Airway inflammation will be assessed using the ECP.
Measured: Basline
Immunoglobulin E (IgE)
Airway inflammation will be assessed using the IgE.
Measured: Basline
Secondary outcomes (5)
Fractional exhaled nitric oxide (FeNO)
Higher FeNO values indicate higher airway inflammation.
Measured: Basline
Forced expiratory volume in one second (FEV1)
Lung function will be assessed using the FEV1.
Measured: Basline
Forced vital capacity (FVC)
Lung function will be assessed using the FEV1.
Measured: Basline
FVC as the percentage of the predicted value (FVC%)
Lung function will be assessed using the FVC%.
Measured: Basline
Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)
Lung function will be assessed using the FEV1/FVC.
Measured: Basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Apr 2023
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined Allergic Rhinitis and Asthma SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 270 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573450
- Sponsor's protocol ID
- EBC biomarkers in CARAS
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Application and Evaluation of Exhaled Breath Condensate Biomarkers in Combined Allergic Rhinitis and Asthma Syndrome (CARAS)
- ClinicalTrials.gov ID
- NCT06573450
- Acronym / sponsor ID
- EBC biomarkers in CARAS
- Keywords
- CARAS, EBC, Biomarkers, Combination of disease and evidence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 27 Aug 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.
To explore the differences in the expression of biomarkers in different sample types between the healthy population and different subgroups of the disease, and to screen for potential biomarkers in a more simple, direct and objective way. To screen the biomarkers that can be identified by CARAS Chinese medicine symptoms and different stages, and to provide a reference basis for individualised diagnosis and treatment of the disease.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| acute exacerbation CARAS | – | Other: questionnaire surveyThirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. |
| chronic persistence CARAS | – | Other: questionnaire surveyThirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. |
| clinical control CARAS | – | Other: questionnaire surveyThirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. |
| acute exacerbation BA | – | Other: questionnaire surveyThirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. |
| chronic persistence BA | – | Other: questionnaire surveyThirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. |
| clinical control BA | – | Other: questionnaire surveyThirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. |
| intermittent AR | – | Other: questionnaire surveyThirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. |
| persistent AR | – | Other: questionnaire surveyThirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. |
| healthy individuals | – | Other: questionnaire surveyThirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Allergic rhinitis (AR) is a common chronic inflammatory disease of the upper respiratory tract with paroxysmal sneezing, nasal congestion, watery nasal discharge and nasal itching as the main clinical symptoms. Bronchial asthma (BA) is a complex heterogeneous chronic inflammatory disease of the bronchi with recurrent symptoms of wheezing, shortness of breath, chest tightness, and coughing.AR usually coexists with BA, and about 70-90% of patients with asthma develop rhinitis, and about 40% of patients with rhinitis develop asthma. When AR and BA occur together, it is called combined allergic rhinitis and asthma syndrome (CARAS).
Key inclusion criteria (5 listed)
- Patients with AR, BA and CARAS who meet the Western medical diagnostic criteria;
- Chinese medical evidence consistent with lung qi deficiency evidence, phlegm-heat congestion of the lung evidence, or wind-heat offending the lung evidence;
- Age 18 to 80 years;
- Voluntarily accepted the study and signed an informed consent form;
- Not participated in other clinical studies within 1 month before enrollment.
Key exclusion criteria (5 listed)
- Patients with combined vasomotor rhinitis and eosinophilic non-allergic rhinitis, other non-allergic rhinitis diseases that can cause symptoms such as nasal congestion and runny nose;
- Patients who are participating in other drug trials;
- Patients with a combination of other serious systemic diseases;
- Pregnant or lactating women;
- Patients with confusion, disorders of consciousness, dementia, and various psychiatric disorders.
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 |
|---|---|---|
| questionnaire surveysubjects fill out questionnaires | Other | acute exacerbation BA, acute exacerbation CARAS, chronic persistence BA, chronic persistence CARAS, clinical control BA, clinical control CARAS, healthy individuals, intermittent AR, persistent AR |
Primary outcome
Interleukin-2、4、5、13 (IL-2、4、5、13)
Time frame: Basline
Airway inflammation will be assessed using the IL-2、4、5、13.
Interferon-γ (IFN-γ)
Time frame: Basline
Airway inflammation will be assessed using the IFN-γ.
Tumor necrosis factor-β (TNF-β)
Time frame: Basline
Airway inflammation will be assessed using the TNF-β.
Eosinophil cationic proteins (ECP)
Time frame: Basline
Airway inflammation will be assessed using the ECP.
Immunoglobulin E (IgE)
Time frame: Basline
Airway inflammation will be assessed using the IgE.
5 secondary outcomes
Fractional exhaled nitric oxide (FeNO)
Time frame: Basline
Forced expiratory volume in one second (FEV1)
Time frame: Basline
Forced vital capacity (FVC)
Time frame: Basline
FVC as the percentage of the predicted value (FVC%)
Time frame: Basline
Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)
Time frame: Basline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Combined Allergic Rhinitis and Asthma Syndrome, run by Henan University of Traditional Chinese Medicine at 1 site in China.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Xie (13526621325, xieyanghn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-2、4、5、13 (IL-2、4、5、13) (time frame: Basline). The study lists 5 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 28 Aug 2024.