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Clinical Characteristics of Severe Childhood Asthma

NCT ID: NCT06024902

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Severe Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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childhood asthma

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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2023-002

Identifier Type: -

Identifier Source: org_study_id