Mold Sensitization Associated Severe Asthma Exacerbation

March 13, 2019 updated by: Nualanong Visitsunthorn, Mahidol University

Is Mold Sensitization Associated With Severe Asthma Exacerbation in Children?

Mold sensitization is associated with severe asthma exacerbation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mold sensitization has been reported to be one of the factors that is associated with severe asthma exacerbation (SAE). The objective is to identify the factors that are associated with SAE in asthmatic children particularly mold sensitization.

Study Type

Observational

Enrollment (Actual)

102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asthmatic children aged 1-15 years old from Pediatric Allergy and Immunology division devided in to 2 groups: 1. hospitalized due to severe asthma exacerbation in a preceding year and 2. without severe asthma exacerbation in a preceding year

Description

Inclusion Criteria:

  • Asthmatic children aged 1-15 years old from Pediatric Allergy and Immunology division with hospitalized due to severe asthma exacerbation in a preceding year and without severe asthma exacerbation in a preceding year

Exclusion Criteria:

  • Other serious systemic diseases, pregnant, lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Skin test in severe asthma exacerbation
Skin test in asthmatic children hospitalized due to severe asthma exacerbation in a preceding year
Other: Skin test
Demographic data review, Disease severity evaluation, Treatment evaluation and Skin prick test for 16 common aeroallergens
skin test in outpatient
Skin test in asthmatic children without severe asthma exacerbation in a preceding year
Other: Skin test
Demographic data review, Disease severity evaluation, Treatment evaluation and Skin prick test for 16 common aeroallergens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between mold sensitization and severe asthma exacerbation
Time Frame: 1 year
Compare mean wheal diameter (mm.) of skin prick test of mold allergen extracts between the group with severe asthma exacerbation and the group without severe asthma exacerbation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

September 23, 2018

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 15, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 271/2560(EC4)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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