Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06024902 |
| Other study ID # |
2023-002 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
December 2023 |
| Source |
Children's Hospital of Fudan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
