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Completed

NCT Number: NCT06024902

Clinical Characteristics of Severe Childhood Asthma

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.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Severity of asthma

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 6, 2023
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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