Asthma in ChildrenNCT05800379
Study on Hospitalization of Children With Bronchial Asthma
An observational study of Asthma in Children, run by Beijing Children's Hospital at 1 site in China.
Trial summary
Bronchial asthma is the most common chronic respiratory disease in children. At present, more attention has been paid to the treatment of airway inflammation and smooth muscle spasm, while the related research on the risk factors of asthma attack, mucus plug formation and its effect on asthma has been ignored. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Asthma in Children
- How many people
- 470 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Apr 2025
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children admitted with acute episodes of asthma
Who may be able to join
- Children admitted with acute episodes of asthma between January 2016 and December 2021
Who cannot join
- Basic information is incomplete
- Lack of relevant information on diagnosis and treatment after admission
- Those who disagree with the telephone follow-up
- Basic diseases such as heart, liver and kidney
- Children with primary or secondary immunodeficiency, genetic metabolic diseases, tumors, or after organ or hematopoietic stem cell transplantation
- Active pulmonary tuberculosis and children with a history of asthma who are hospitalized for other reasons
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Children's Hospital affiliated to Capital Medical University
Beijing
About this study
Bronchial asthma is the most common chronic respiratory disease in children. At present, more attention has been paid to the treatment of airway inflammation and smooth muscle spasm, while the related research on the risk factors of asthma attack, mucus plug formation and its effect on asthma has been ignored. This study was a retrospective study. Children hospitalized for acute exacerbation of asthma from 2016 to 2021 were selected as the research objects. The clinical manifestations, bronchoscopy results and lung CT results of children hospitalized for acute exacerbation of asthma were summarized. To analyze the risk factors of acute exacerbation, clinical characteristics, risk factors of mucus plug formation in hospitalized children with asthma, and the safety and efficacy of flexible bronchoscopy in the diagnosis and treatment of hospitalized children with asthma. The discharged children were investigated by written or online questionnaires to understand the acute attack of asthma, control level, compliance, appliability of the China Children's Asthma Action Plan, family management and medical utilization of children with asthma after discharge.
Read the detailed description
Asthma is the most common chronic respiratory disease in children. The prevalence of asthma in children in China increased by nearly 50% in 2010 compared with 2000, and the proportion of children hospitalized for asthma exacerbation also increased. China has a large population base, and the number of children with asthma is large. Acute asthma attack is mainly characterized by airway smooth muscle contraction and mucus plug obstruction. At present, more attention has been paid to the treatment of airway mucosal inflammation and smooth muscle spasm, while the related research on the risk factors of asthma acute attack, mucus plug formation and its effect on asthma has been ignored. Bronchoscopy can directly and effectively remove the mucus plug formed in the airway of children with asthma, but there is a lack of clear application standards and procedures. Identifying the risk factors of mucus plug formation in hospitalized children with asthma exacerbation, identifying mucus plug, timely and targeted treatment, and education and training after discharge are of great significance to reduce the hospitalization rate and mortality.This study was a retrospective study. Children hospitalized for acute exacerbation of asthma from 2016 to 2021 were selected as the research objects. The clinical manifestations, bronchoscopy results and lung CT results of children hospitalized for acute exacerbation of asthma were summarized. To analyze the risk factors of acute exacerbation, clinical characteristics, risk factors of mucus plug formation in hospitalized children with asthma, and the safety and efficacy of flexible bronchoscopy in the diagnosis and treatment of hospitalized children with asthma. The discharged children were investigated by written or online questionnaires to understand the acute attack of asthma, control level, compliance, appliability of the China Children's Asthma Action Plan, family management and medical utilization of children with asthma after discharge.
- Conditions
- Asthma in Children
- Keywords
- asthma, children, mucus plug, Flexible bronchoscope
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics of hospitalized children with acute asthma attack
clinical characteristics includes: age, sex, asthma severity (mild, severe), asthma inducing factors(infection, allergy, smoke, excerise) and hospitalization expenses
Measured: From January 2016 to December 2021
Influencing factors of acute attack severity in hospitalized children with asthma
age, sex, allergy history, birth history, family history, the severity of asthma exacerbation, lung function and lung computed tomography
Measured: From January 2016 to December 2021
Risk factors for acute exacerbation of asthma with respiratory failure in children
The proportion of children hospitalized for acute exacerbation of asthma with respiratory failure, and age, sex, allergy history（with or without）, family history (asthma, atopic dermatitis,rhinitis and allergy), the severity of asthma exacerbation(mild, severe), lung function (normal, abnormal) and lung computed tomography(normal, abnormal)
Measured: From January 2016 to December 2021
Risk factors for mucus plug formation in hospitalized children with asthma exacerbation
The results of lung CT examination in children with asthma(normal, abnormal), the incidence of mucus plug in hospitalized children with asthma
Measured: From January 2016 to December 2021
Identification of mucus plugs in hospitalized children with asthma
Using mucus scoring system which was based on bronchopulmonary segmental anatomy identified mucus plugs in hospitalized children with asthma. Each bronchopulmonary segment was given a score of 1 (mucus plug present) or 0 (mucus plug absent). The segment scores of each lobe were summed to generate a total mucus score for both lungs, yielding a mucus score ranging from 0-20.
Measured: From January 2016 to December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Jul 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunling Shen, Beijing Children's Hospital
- Investigators
- kunling shen, doctor, Principal investigator, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800379
- Sponsor's protocol ID
- BCH Lung 010
- Status last verified
- Oct 2023
- First submitted
- 1 Mar 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han P, Yin J, Zou H, Jiao A, Liu Y, Shen K. Exploring the types of airway inflammation in hospitalized children with asthma. BMC Pediatr. 2025 May 7;25(1):359. doi: 10.1186/s12887-025-05596-7.
PubMed 40329237
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Hospitalization of Children With Bronchial Asthma
- ClinicalTrials.gov ID
- NCT05800379
- Acronym / sponsor ID
- BCH Lung 010
- Conditions
- Asthma in Children
- Keywords
- asthma, children, mucus plug, Flexible bronchoscope
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 5 Apr 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.
Bronchial asthma is the most common chronic respiratory disease in children. At present, more attention has been paid to the treatment of airway inflammation and smooth muscle spasm, while the related research on the risk factors of asthma attack, mucus plug formation and its effect on asthma has been ignored. This study was a retrospective study. Children hospitalized for acute exacerbation of asthma from 2016 to 2021 were selected as the research objects. The clinical manifestations, bronchoscopy results and lung CT results of children hospitalized for acute exacerbation of asthma were summarized. To analyze the risk factors of acute exacerbation, clinical characteristics, risk factors of mucus plug formation in hospitalized children with asthma, and the safety and efficacy of flexible bronchoscopy in the diagnosis and treatment of hospitalized children with asthma. The discharged children were investigated by written or online questionnaires to understand the acute attack of asthma, control level, compliance, appliability of the China Children's Asthma Action Plan, family management and medical utilization of children with asthma after discharge.
Detailed description
Asthma is the most common chronic respiratory disease in children. The prevalence of asthma in children in China increased by nearly 50% in 2010 compared with 2000, and the proportion of children hospitalized for asthma exacerbation also increased. China has a large population base, and the number of children with asthma is large. Acute asthma attack is mainly characterized by airway smooth muscle contraction and mucus plug obstruction. At present, more attention has been paid to the treatment of airway mucosal inflammation and smooth muscle spasm, while the related research on the risk factors of asthma acute attack, mucus plug formation and its effect on asthma has been ignored. Bronchoscopy can directly and effectively remove the mucus plug formed in the airway of children with asthma, but there is a lack of clear application standards and procedures. Identifying the risk factors of mucus plug formation in hospitalized children with asthma exacerbation, identifying mucus plug, timely and targeted treatment, and education and training after discharge are of great significance to reduce the hospitalization rate and mortality.This study was a retrospective study. Children hospitalized for acute exacerbation of asthma from 2016 to 2021 were selected as the research objects. The clinical manifestations, bronchoscopy results and lung CT results of children hospitalized for acute exacerbation of asthma were summarized. To analyze the risk factors of acute exacerbation, clinical characteristics, risk factors of mucus plug formation in hospitalized children with asthma, and the safety and efficacy of flexible bronchoscopy in the diagnosis and treatment of hospitalized children with asthma. The discharged children were investigated by written or online questionnaires to understand the acute attack of asthma, control level, compliance, appliability of the China Children's Asthma Action Plan, family management and medical utilization of children with asthma after discharge.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children admitted with acute episodes of asthma
Key inclusion criteria (1 listed)
- Children admitted with acute episodes of asthma between January 2016 and December 2021
Key exclusion criteria (6 listed)
- Basic information is incomplete
- Lack of relevant information on diagnosis and treatment after admission
- Those who disagree with the telephone follow-up
- Basic diseases such as heart, liver and kidney
- Children with primary or secondary immunodeficiency, genetic metabolic diseases, tumors, or after organ or hematopoietic stem cell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical characteristics of hospitalized children with acute asthma attack
Time frame: From January 2016 to December 2021
clinical characteristics includes: age, sex, asthma severity (mild, severe), asthma inducing factors(infection, allergy, smoke, excerise) and hospitalization expenses
Influencing factors of acute attack severity in hospitalized children with asthma
Time frame: From January 2016 to December 2021
age, sex, allergy history, birth history, family history, the severity of asthma exacerbation, lung function and lung computed tomography
Risk factors for acute exacerbation of asthma with respiratory failure in children
Time frame: From January 2016 to December 2021
The proportion of children hospitalized for acute exacerbation of asthma with respiratory failure, and age, sex, allergy history（with or without）, family history (asthma, atopic dermatitis,rhinitis and allergy), the severity of asthma exacerbation(mild, severe), lung function (normal, abnormal) and lung computed tomography(normal, abnormal)
Risk factors for mucus plug formation in hospitalized children with asthma exacerbation
Time frame: From January 2016 to December 2021
The results of lung CT examination in children with asthma(normal, abnormal), the incidence of mucus plug in hospitalized children with asthma
Identification of mucus plugs in hospitalized children with asthma
Time frame: From January 2016 to December 2021
Using mucus scoring system which was based on bronchopulmonary segmental anatomy identified mucus plugs in hospitalized children with asthma. Each bronchopulmonary segment was given a score of 1 (mucus plug present) or 0 (mucus plug absent). The segment scores of each lobe were summed to generate a total mucus score for both lungs, yielding a mucus score ranging from 0-20.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Derived from this study: PubMed 40329237Han P, Yin J, Zou H, Jiao A, Liu Y, Shen K. Exploring the types of airway inflammation in hospitalized children with asthma. BMC Pediatr. 2025 May 7;25(1):359. doi: 10.1186/s12887-025-05596-7.
- 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. This study is not recruiting at the moment.
kunling shen, doctor principal investigator
Beijing Children's Hospital
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 Beijing Children's Hospital 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 1 inclusion and 6 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 17 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kunling shen, doctor (+86-010-59616313, kunlingshen1717@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical characteristics of hospitalized children with acute asthma attack (time frame: From January 2016 to December 2021). 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?
On the ClinicalTrials.gov record for NCT05800379, which also lists 1 linked publication.
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 17 Oct 2023.