Control and Treatment of Outpatient Children With Asthma

The aim of this study is to comprehensively understand the disease control and management status of children with asthma in China, as well as the types of airway inflammation. The findings of this survey will help improve the asthma control level in Chinese children, facilitate future patient education, and guide rational medication use. Moreover, it will provide important evidence for health decision-making departments to better allocate and utilize medical resources.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

Bronchial asthma (hereinafter referred to as asthma) is the most common chronic respiratory disease in children. It severely affects the physical and mental health of children and imposes a huge economic burden on families and society, consuming a large amount of medical and health resources. In recent years, the prevalence of asthma in children worldwide has generally continued to rise. Data from the Global Burden of Disease database in 2019 showed that the prevalence of asthma in children aged 0-9 years was 4.21%, in children aged 10-14 years was 4.10%, and in adolescents aged 15-19 years was 3.00%. In China, over the past 20 years, the prevalence of asthma in children has also shown an overall upward trend, increasing from 0.91% in 1990 to 1.54% in 2000, and then to 3.02% in 2010. Thanks to the continuous efforts of several generations of pediatricians, the level of standardized diagnosis and treatment of childhood asthma has significantly improved. However, the control of asthma in children still faces many challenges.

The purpose of this study is to comprehensively understand the disease control and management status of children with asthma in China, as well as the types of airway inflammation. The findings of this survey will help improve the asthma control level in Chinese children, facilitate future patient education, guide rational medication use, and provide important evidence for health decision-making departments to better allocate and utilize medical resources.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 2 and 18 years old
Diagnosed with asthma for more than 3 months
Had asthma symptoms or asthma treatment within the past 12 months.

Exclusion criteria

With other respiratory diseases such as bronchiectasis, bronchiolitis, cystic fibrosis, and pneumonia
Have participated in any interventional clinical studies related to asthma within the 3 months prior to enrollment in this study
Parents, legal representatives, or guardians do not agree to participate in this study.

Treatment and study plan

Questionnaire and Physical Exam

Other

Questionnaire and Physical Exam

Primary outcomes

Asthma control level

Time frame: 3 months before and at the time of enrollment

The Asthma Control Test (ACT) will be employed for assessment, with the following interpretation criteria: a total score of 20-25 indicates well-controlled asthma, where symptoms are satisfactorily managed and the current treatment regimen should be continued; a score of 16-19 suggests poorly controlled asthma, indicating suboptimal symptom management that requires treatment adjustment or enhanced disease management; and a score of 5-15 reflects very poorly controlled asthma, with severe uncontrolled symptoms necessitating immediate medical attention and treatment modification.
The proportion of type 2 inflammation

Time frame: 3 months before and at the time of enrollment

Blood EOS and IgE were used to judge. The T2 inflammatory phenotypes were classified based on blood eosinophil count and total specific IgE levels: Only-atopy was defined as blood eosinophils <300/μL with sum of all specific IgE ≥0.7 kU/L; Only-EOS as blood eosinophils ≥300/μL with sum of all specific IgE <0.7 kU/L; T2-high as blood eosinophils ≥300/μL with sum of all specific IgE ≥0.7 kU/L; and T2-low as blood eosinophils <300/μL with sum of all specific IgE <0.7 kU/L.

Study contacts

Contact information is provided by the study sponsor or research team.

Peng Han, Doctor

CONTACT

[email protected]

+86-18612935979

Sponsors and collaborators

Lead sponsor

Beijing Children's Hospital

Other

Registry information

Official study title

A Multicenter Observational Study on the Current Status of Control and Treatment of Outpatient Children With Asthma and the Types of Airway Inflammation

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Feb 20, 2025
Registry last updated: Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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