Asthma in ChildrenNCT05768399
The Role of Biomarkers in the Occurrence and Development of Asthma
An observational study of Asthma in Children, run by Children's Hospital of Chongqing Medical University at 1 site in China.
Trial summary
To study the expression level of biomarkers such as GITRL in peripheral blood of children with asthma and analyze their correlation with the severity of asthma. To study the predictive value of biomarkers level for the occurrence and development of asthma. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- What is being tested?
- The level of biomarkers in Peripheral blood
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2023to 31 Dec 2029
- Phase
- Observational
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with typical asthma symptoms, such as cough, wheezing, chest tightness, dyspnea and abnormal lung function tests, were diagnosed with asthma by a respiratory doctor
Who may be able to join
- In line with the diagnostic criteria in the Guidelines for the Diagnosis and Prevention of Bronchial Asthma in Children (2016 Edition)
- Age: 4-12 years old for new diagnosis or recurrent episodes
- Typical clinical manifestations and complete clinical data
- Family members or guardians of children with informed research and signed consent
- All healthy control subjects had no history of lung disease, allergic rhinitis or any other atopic disease
Who cannot join
- Suffering from other respiratory diseases (such as bronchiectasis, allergic rhinitis, respiratory failure, tuberculosis, obstructive airway disease) or other inflammatory diseases.
- Abnormal development of congenital airway and lung tissue
- History of immunosuppressant or glucocorticoid use in the first 4 weeks
- Suffering from other endocrine system and immune system diseases
- Incomplete clinical data or examinations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shaoqing Zhang
Chongqing, Chongqing Municipality, 400000
Yuehan Li, PHD student, 15397618298, 1214987864@qq.com
About this study
To study the expression level of biomarkers such as GITRL in peripheral blood of children with asthma and analyze their correlation with the severity of asthma. To study the predictive value of biomarkers level for the occurrence and development of asthma. And to provide supplementary detection means and predictive indicators for the diagnosis of asthma and the severity of asthma.
Read the detailed description
Recruit 30 children with asthma and 30 healthy children based on the consent of the children and their parents or their guardian. Collect and record general information such as name, age, time of first diagnosis, allergens or triggers, daily dosage and frequency of asthma control drugs, home address and contact information. Collect 5 ml of blood sample for the detect of the biomarkers. Asthma severity was assessed using pulmonary function by spirometry and score of C-CAT. Finally study the correlation between the level of biomarkers and asthma severity and the role of biomarkers in the occurrence and development of asthma.
- Conditions
- Asthma in Children
- Being tested
- The level of biomarkers in Peripheral blood
- Keywords
- asthma, children, biomarkers
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The level of biomarkers in Peripheral bloodDiagnostic test
Also called pulmonary function, blood test, specific IgE
All participants will be extracted 5ml peripheral blood into the anticoagulant tube by nurses and the peripheral blood will be detected for biomarkers of asthma. Children with asthma will take pulmonary function, blood test and specific IgE test etc. The lung function test will be performed by professional technicians and the results will be interpreted by specialists. The blood test and specific IgE test will be collected by specialist nurses and the results will be issued by professional inspectors. Children with asthma and their guardians will be asked for filling the questionnaire of Childhood Asthma Control Test (C-ACT). And then the doctor will check and calculate the scores after completion.
| Study group | Role | What they receive |
|---|---|---|
| Asthma group | Children with asthma diagnosed by a respiratory physician Receives: Diagnostic Test: The level of biomarkers in Peripheral blood | |
| Control group | Children without respiratory disease or inflammatory diseases Receives: Diagnostic Test: The level of biomarkers in Peripheral blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of biomarkers
All participants will be extracted 5ml peripheral blood into the anticoagulant tube by nurses and the peripheral blood will be detected for biomarkers of asthma using RT-qPCR、 ELISA、 Flow cytometry and other methods.
Measured: 2years
Secondary outcomes (7)
Pulmonary function（FEV1%）
The correlation of pulmonary function （FEV1） and the level of biomarkers in children with asthma.The lung function test will be performed by professional technicians and the results will be interpreted by specialists.
Measured: 2 years
Pulmonary function（FVC%）
The correlation of pulmonary function （FVC%） and the level of biomarkers in children with asthma.The lung function test will be performed by professional technicians and the results will be interpreted by specialists.
Measured: 2 years
Pulmonary function（FEV1/FVC）
The correlation of pulmonary function （FEV1/FVC） and the level of biomarkers in children with asthma.The lung function test will be performed by professional technicians and the results will be interpreted by specialists.
Measured: 2 years
Pulmonary function（PEF%）
The correlation of pulmonary function （PEF%） and the level of biomarkers in children with asthma.The lung function test will be performed by professional technicians and the results will be interpreted by specialists.
Measured: 2 years
specific IgE
The correlation of blood specific IgE and the level of biomarkers in children with asthma
Measured: 2 years
Peripheral blood eosinophil count
The correlation of peripheral blood eosinophil count and the level of biomarkers in children with asthma
Measured: 2 years
Childhood Asthma Control Test (C-ACT)
The correlation of the score of C-ACT and the level of biomarkers in children with asthma. Children with asthma and their guardians will be asked for filling the questionnaire of Childhood Asthma Control Test (C-ACT). And then the doctor will check and calculate the scores after completion.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start4 Jul 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengxia Ding, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768399
- Sponsor's protocol ID
- File No.2023.225
- Status last verified
- Jul 2023
- First submitted
- 7 Feb 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Biomarkers in the Occurrence and Development of Asthma
- ClinicalTrials.gov ID
- NCT05768399
- Acronym / sponsor ID
- File No.2023.225
- Conditions
- Asthma in Children
- Keywords
- asthma, children, biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 Mar 2023 (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 study the expression level of biomarkers such as GITRL in peripheral blood of children with asthma and analyze their correlation with the severity of asthma. To study the predictive value of biomarkers level for the occurrence and development of asthma. And to provide supplementary detection means and predictive indicators for the diagnosis of asthma and the severity of asthma.
Detailed description
Recruit 30 children with asthma and 30 healthy children based on the consent of the children and their parents or their guardian. Collect and record general information such as name, age, time of first diagnosis, allergens or triggers, daily dosage and frequency of asthma control drugs, home address and contact information. Collect 5 ml of blood sample for the detect of the biomarkers. Asthma severity was assessed using pulmonary function by spirometry and score of C-CAT. Finally study the correlation between the level of biomarkers and asthma severity and the role of biomarkers in the occurrence and development of asthma.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma group | – | Diagnostic Test: The level of biomarkers in Peripheral bloodChildren with asthma diagnosed by a respiratory physician |
| Control group | – | Diagnostic Test: The level of biomarkers in Peripheral bloodChildren without respiratory disease or inflammatory diseases |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with typical asthma symptoms, such as cough, wheezing, chest tightness, dyspnea and abnormal lung function tests, were diagnosed with asthma by a respiratory doctor
Key inclusion criteria (5 listed)
- In line with the diagnostic criteria in the Guidelines for the Diagnosis and Prevention of Bronchial Asthma in Children (2016 Edition)
- Age: 4-12 years old for new diagnosis or recurrent episodes
- Typical clinical manifestations and complete clinical data
- Family members or guardians of children with informed research and signed consent
- All healthy control subjects had no history of lung disease, allergic rhinitis or any other atopic disease
Key exclusion criteria (5 listed)
- Suffering from other respiratory diseases (such as bronchiectasis, allergic rhinitis, respiratory failure, tuberculosis, obstructive airway disease) or other inflammatory diseases.
- Abnormal development of congenital airway and lung tissue
- History of immunosuppressant or glucocorticoid use in the first 4 weeks
- Suffering from other endocrine system and immune system diseases
- Incomplete clinical data or examinations.
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 |
|---|---|---|
| The level of biomarkers in Peripheral bloodAlso: pulmonary function, blood test, specific IgEAll participants will be extracted 5ml peripheral blood into the anticoagulant tube by nurses and the peripheral blood will be detected for biomarkers of asthma. Children with asthma will take pulmonary function, blood test and specific IgE test etc. The lung function test will be performed by professional technicians and the results will be interpreted by specialists. The blood test and specific IgE test will be collected by specialist nurses and the results will be issued by professional inspectors. Children with asthma and their guardians will be asked for filling the questionnaire of Childhood Asthma Control Test (C-ACT). And then the doctor will check and calculate the scores after completion. | Diagnostic test | Asthma group, Control group |
Primary outcome
The level of biomarkers
Time frame: 2years
All participants will be extracted 5ml peripheral blood into the anticoagulant tube by nurses and the peripheral blood will be detected for biomarkers of asthma using RT-qPCR、 ELISA、 Flow cytometry and other methods.
7 secondary outcomes
Pulmonary function（FEV1%）
Time frame: 2 years
Pulmonary function（FVC%）
Time frame: 2 years
Pulmonary function（FEV1/FVC）
Time frame: 2 years
Pulmonary function（PEF%）
Time frame: 2 years
specific IgE
Time frame: 2 years
Peripheral blood eosinophil count
Time frame: 2 years
Childhood Asthma Control Test (C-ACT)
Time frame: 2 years
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 7 Jul 2023.
- Individual participant dataSharing planned: No
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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.
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 Asthma in Children, run by Children's Hospital of Chongqing Medical University 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: looking for participants now, as of the sponsor's last update on 7 Jul 2023. 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?
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 Ding Fengxia, PhD (86-15178712548 ext. 86-18090164586, dingfengxia305@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of biomarkers (time frame: 2years). 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 7 Jul 2023.