NCT04525586

Brief Summary

Asthma is the most common chronic disease in children, however, underdiagnosis of childhood asthma is an important issue in asthma management. The lack of reliable and objective diagnostic indicators requires the development of rapid and accurate strategies for the early diagnosis of childhood asthma. Recent studies have found a correlation between long-chain non-coding RNA (lncRNA) expression and childhood asthma, suggesting that lncRNA may be a potential biomarker for asthma diagnosis.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Status
withdrawn

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

First Submitted

Initial submission to the registry

August 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 31, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

August 21, 2020

Last Update Submit

December 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • rate of early diagnosis of childhood asthma

    a diagnosis of transient wheeze or asthma was made by a pediatric pulmonologist. This classification was based on symptoms, use of asthma medication, and lung function features.

    24 months

Study Arms (1)

It's just an observational study, no interventions

children with recurrent wheezing

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with recurrent wheezing who apply to Department of Respiratory Medicine, Children's Hospital of Fudan University.

You may qualify if:

  • children with recurrent wheezing

You may not qualify if:

  • diagnosis of other chronic respiratory disease (e.g. cystic fibrosis, bronchopulmonary dysplasia, etc)
  • immunodeficiency- acquired or congenital
  • neuromuscular disease
  • congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

Study Officials

  • Liling Qian, PhD.

    Children's Hospital of Fudan University

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2020

First Posted

August 25, 2020

Study Start

December 31, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

December 9, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

The investigators do not currently have an individual participant data sharing plan. However, de-identified research data/documents may be shared in the future with other investigators who share similar research interests. Specimens and data will not be released without (1) PI written permission and (2) appropriate Institutional Review Board (IRB) approval. Data use and/or material transfer agreements will also be required as applicable to outside researchers.