Control and Treatment of Outpatient Children With Asthma

NCT06837584 | Not Yet Recruiting

• 1 other identifier: Asthma 002
• Study Type: observational
• Target: 42,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

asthma; children; outpatients; management; control

Outcome Measures

Primary Outcomes (2)

• Asthma control level

  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.

  3 months before and at the time of enrollment

• The proportion of type 2 inflammation

  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.

  3 months before and at the time of enrollment

Interventions

Questionnaire and Physical Exam OTHER

Questionnaire and Physical Exam

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 2-18 years and diagnosed with asthma ≥3 months were enrolled in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Children's Hospital: lead

MeSH Terms

Conditions

Asthma

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Central Study Contacts

Peng Han, Doctor

CONTACT

+86-18612935979; hanpengonly1@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professior

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL