NCT03690349

Brief Summary

Mold sensitization is associated with severe asthma exacerbation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Status
completed

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

Study Start

First participant enrolled

January 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

September 25, 2018

Last Update Submit

March 13, 2019

Conditions

Asthma

Keywords

severe asthma exacerbationMold sensitization

Outcome Measures

Primary Outcomes (1)

  • Association between mold sensitization and severe asthma exacerbation

    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

Study Arms (2)

Skin test in severe asthma exacerbation

Skin test in asthmatic children hospitalized due to severe asthma exacerbation in a preceding year

Other: Skin test

skin test in outpatient

Skin test in asthmatic children without severe asthma exacerbation in a preceding year

Other: Skin test

Interventions

Skin testOTHER

Demographic data review, Disease severity evaluation, Treatment evaluation and Skin prick test for 16 common aeroallergens

Skin test in severe asthma exacerbationskin test in outpatient

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Other serious systemic diseases, pregnant, lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Skin Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2018

First Posted

October 1, 2018

Study Start

January 1, 2017

Primary Completion

April 30, 2018

Study Completion

September 23, 2018

Last Updated

March 15, 2019

Record last verified: 2019-03