NCT05765383

Brief Summary

The goal of this observational study is to 1)analyze the basic information of confirmed cases of asthma in children aged 5-12 years old hospitalized in the First Affiliated Hospital of Guangzhou Medical University from 2009 to 2020, 2)investigate the onset of asthma after 13 years old, 3)conducte lung function, blood and airway inflammation indicators, blood IL13 and IL1RL1 levels, 4)analyze the prognosis and influencing factors of children with asthma in this age group.Participants will be asked to fill a case report form and questionnaires. Besides, they should provide examination results like lung function, total IgE, expired nitric oxide, blood and sputum granulocyte counts, and determination of blood IL13 and IL1RL1 levels over the past 6 months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

March 1, 2023

Last Update Submit

March 1, 2023

Conditions

Keywords

prognosisrisk factorsphenotypePersistent asthma

Outcome Measures

Primary Outcomes (3)

  • Review and collation.

    To collect the case data of asthma in children aged 5 - 12 and analyze its clinical phenotype.

    2022.08-2022.10

  • Case follow-up

    The case report form and C-ACT/ACT questionnaire will be filled out. Patients should provide specific examination results.

    2022.10-2022.12

  • Data analysis

    Analyze the data obtained.

    2023.1-2023.2

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized children with asthma (age range 5-12 years old) from 2009 to 2020 in the First Affiliated Hospital of Guangzhou Medical University were collected.

You may qualify if:

  • Hospitalized children with asthma (age range 5-12 years old) from 2009 to 2020 in the First Affiliated Hospital of Guangzhou Medical University were collected. Diagnostic criteria were included by referring to global initiative for asthma and Guidelines for Diagnosis, Prevention and Treatment of Pediatric Bronchial Asthma revised in 2008.

You may not qualify if:

  • Children who declined follow-up
  • Children with pulmonary and tracheal dysplasia, bronchiolitis obliterans, and other conditions leading to wheezing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 13, 2023

Study Start

August 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

March 13, 2023

Record last verified: 2023-03

Locations