Clinical Characteristics of Severe Childhood Asthma

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT06024902
Collaborator
(none)
674
1
24
28.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Participants were consecutively recruited from asthma clinics between January 2021 and December 2021 at Children's Hospital of Fudan University. Patients fulfilling the following criteria were eligible for inclusion: (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. Patients who had cystic fibrosis, mechanical airway obstruction, or any other pulmonary disease or whose parents or legal guardians were not able to fill in the questionnaires were not enrolled.

    At baseline, the asthma specialist questioned each of the patient in the presence of their caregivers to ensure that they supplied accurate disease information and were included according to the criteria. The patients and their caregivers are asked to complete the online questionnaires including the demographic; baseline asthma control, triggers, exacerbation, medication and adherence; environmental exposure, and diagnosis and control of comorbidities, etc. If a patient had poorly controlled comorbidities, multidisciplinary consultation would be recommended. Clinical assessments were arranged at baseline, 3, 6, 9, and 12 months.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    674 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Clinical Characteristics of Severe Childhood Asthma
    Actual Study Start Date :
    Jan 1, 2021
    Actual Primary Completion Date :
    Dec 31, 2022
    Actual Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    childhood asthma

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

    Outcome Measures

    Primary Outcome Measures

    1. Severity of asthma [12 months]

      The severity of asthma was comprehensively estimated by a pediatric pulmonologist following the criteria of the Global Initiative for Asthma (GINA) 2021 when patients completed 12-months management.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • (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.

    Exclusion Criteria:
    • (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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Fudan University Shanghai Shanghai China 201102

    Sponsors and Collaborators

    • Children's Hospital of Fudan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital of Fudan University
    ClinicalTrials.gov Identifier:
    NCT06024902
    Other Study ID Numbers:
    • 2023-002
    First Posted:
    Sep 6, 2023
    Last Update Posted:
    Sep 6, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 6, 2023