Clinical trial NCT06837584: Control and Treatment of Outpatient Children with Asthma
Official title: A Multicenter Observational Study on the Current Status of Control and Treatment of Outpatient Children with Asthma and the Types of Airway Inflammation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Asthma
Keywords: asthma
children
outpatients
management
control
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 42000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 2-16 years and diagnosed with asthma ≥3 months were enrolled in the study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age between 2 and 16 years old；Children who have been diagnosed with asthma for more than 3 months;Children who have had asthma symptoms or asthma treatment within the past 12 months.

Exclusion Criteria:

* Children diagnosed with other respiratory diseases such as bronchiectasis, bronchiolitis, cystic fibrosis, and pneumonia; Children who have participated in any interventional clinical studies related to asthma within the 3 months prior to enrollment in this study; Children whose parents, legal representatives, or guardians do not agree to participate in this study.

Primary outcomes:
measure: Asthma control level
timeFrame: 3 months before and at the time of enrollment
measure: The proportion of type 2 inflammation
timeFrame: 3 months before and at the time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: