Predicting Factors for Asthma Remission in Children | NCT02531503

Studies
Predicting Factors for Asthma Remission in Children

NCT02531503

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Mar 22, 2017Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Asthma

Interventions

Clinical asthma remission

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015Actual

Primary Completion Date

Feb 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Aug 19, 2015

First Submission Date that Met QC Criteria

Aug 20, 2015

First Posted Date

Aug 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2017

Last Update Posted Date

Mar 22, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the predicting factors for asthma remission in children.

Detailed Description

Children who were diagnosed as having asthma during the period of 2004-2007 and reevaluated in 2015.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clinical asthma remission		Clinical asthma remission was defined as having no asthma symptoms and no use of asthma medication during the past 12 months.	Other: Clinical asthma remission

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clinical asthma remission	Other	Clinical asthma remission was defined as having no asthma symptoms and no use of medication during the past 12 months.	Clinical asthma remission

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of factors associated with asthma remission		18 months

Secondary Outcomes

Measure	Description	Time Frame
Asthma remission rate		18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children who were diagnosed as having asthma during the period of 2004-2007.

Exclusion Criteria:

Patients who had underlying disease with chronic respiratory disease (ex. tuberculosis, bronchiectasis), primary immunodeficiency, other seriously interfering diseases
Medical records have been lost.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

15 Years

Standard Ages

Child

Study Population

The children who were diagnosed as having asthma at pediatric allergy clinic were recruited.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Division of Allergy and Immunology, Department of Pediatrics,	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University		Bangkok	Bangkok	10700	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided