Clinical Characteristics of Severe Childhood Asthma

NCT06024902 | Completed

• 1 other identifier: 2023-002
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma remains a serious health problem with increasing prevalence and incidence. There is limited information about severe asthma among Chinese pediatric patients. In this context, we decided to explore the clinical characteristics and risk factors of severe asthma in children. This is a descriptive, observational, retrospective cohort study in children with asthma. The purpose of this retrospective study is: to determine the clinical characteristics of severe asthma of children; to identify the factors associated with severe childhood asthma.

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (1)

• Severity of asthma

  The severity of asthma was comprehensively estimated by a pediatric pulmonologist following the criteria of the Global Initiative for Asthma (GINA) 2021(collecting clinical characteristics, questionnaires and Pulmonary function tests)when patients completed 12-months management.

  12 months

Study Arms (1)

childhood asthma

Subjects with confirmed diagnosis of asthma without other lung disease followed for collection of demographic and clinical data.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The tertiary specialized children's hospital

You may qualify if:

• (1) aged 6-17 years old;
• (2) diagnosed with asthma according to the Global Initiative for Asthma (GINA) 2020 guideline;
• (3) children and their caregivers are informed and voluntarily join the database and had follow up for at least 1 year.

You may not qualify if:

• (1) Patients with cystic fibrosis;
• (2) had mechanical airway obstruction, or any other pulmonary disease;
• (3) whose parents or legal guardians were not able to fill in the questionnaires.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 6, 2023
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)