NCT03435822

Brief Summary

This study is a multi-center randomized controlled trial of children with asthma. The objective of the study is to assess the efficacy of China Children Asthma Action Plan (CCAAP), which is the first asthma action plan for children with asthma in China, in asthma management.

Trial Health

35
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 not_applicable

Timeline
Completed

Started Mar 2018

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

February 12, 2018

Last Update Submit

March 16, 2018

Conditions

Asthma in Children

Keywords

asthmachildrenaction planChinaCCAAP

Outcome Measures

Primary Outcomes (1)

  • number of acute episodes of asthma

    number of acute episodes of asthma in a year

    1 year

Secondary Outcomes (8)

  • the changes of FEV1 before and after management

    1 year

  • the score of children's quality of life

    1 year

  • asthma knowledge

    1 year

  • ACT / C-ACT score

    1 year

  • the absent days of school

    1 year

  • +3 more secondary outcomes

Study Arms (2)

asthma action plan management group

OTHER

Patients in this group will be provided both written asthma action plan and mobile-based APP to remind them take medicine regularly and direct them what to do when asthma get worse.

Other: asthma action plan management group

conventional management group

OTHER

Patients in this group will be provided conventional management method with prescriptions and asthma diaries.

Other: conventional management group

Interventions

asthma action plan management groupOTHER

Patients will follow the directions in asthma action plan when their asthma get worse.

Also known as: conventional management group
asthma action plan management group
conventional management groupOTHER

Patients will follow the directions in conventional strategy when their asthma get worse.

conventional management group

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • did not receive control treatment or did not reach well-control;
  • can perform spirometry pulmonary function tests;
  • parents are skilled in using smartphones and APP apps (Android or IOS).

You may not qualify if:

  • reach the level of asthma control;
  • can not use the smartphone APP software;
  • can not cooperate the test of peak expiratory flow;
  • did not treatment coexist respiratory disease effectively (such as sinusitis, obstructive sleep apnea-hypopnea syndrome, etc.);
  • combined with other systemic diseases outside the respiratory system (such as leukemia, rheumatoid arthritis, etc.).
  • receiving allergen-specific immunotherapy.
  • undergoing trial for other medications or instruments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • kunling Shen, MD,PhD

    Beijing Children's Hospital of Capital Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kunling Shen, MD,PhD

CONTACT

59616666kunlingshen1717@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of China National Clinical Research Center for Respiratory Diseases

Study Record Dates

First Submitted

February 12, 2018

First Posted

February 19, 2018

Study Start

March 22, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant available to other researchers so far.