AsthmaNCT03690349
Mold Sensitization Associated Severe Asthma Exacerbation
An observational study of Asthma, run by Mahidol University.
Trial summary
Mold sensitization is associated with severe asthma exacerbation. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Asthma
- What is being tested?
- Skin test
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 23 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- Other serious systemic diseases, pregnant, lactation
About this study
Official title: Is Mold Sensitization Associated With Severe Asthma Exacerbation in Children?
Mold sensitization is associated with severe asthma exacerbation.
Read the 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.
- Conditions
- Asthma
- Being tested
- Skin test
- Keywords
- severe asthma exacerbation, Mold sensitization
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin testOther
Demographic data review, Disease severity evaluation, Treatment evaluation and Skin prick test for 16 common aeroallergens
| Study group | Role | What they receive |
|---|---|---|
| Skin test in severe asthma exacerbation | Skin test in asthmatic children hospitalized due to severe asthma exacerbation in a preceding year Receives: Other: Skin test | |
| skin test in outpatient | Skin test in asthmatic children without severe asthma exacerbation in a preceding year Receives: Other: Skin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Jan 2017
- Primary completion30 Apr 2018
- Study completion23 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nualanong Visitsunthorn, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690349
- Sponsor's protocol ID
- 271/2560(EC4)
- Status last verified
- Mar 2019
- First submitted
- 25 Sep 2018
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Mold Sensitization Associated With Severe Asthma Exacerbation in Children?
- ClinicalTrials.gov ID
- NCT03690349
- Acronym / sponsor ID
- 271/2560(EC4)
- Conditions
- Asthma
- Keywords
- severe asthma exacerbation, Mold sensitization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 23 Sep 2018 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mold sensitization is associated with severe asthma exacerbation.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin test in severe asthma exacerbation | – | Other: Skin testSkin test in asthmatic children hospitalized due to severe asthma exacerbation in a preceding year |
| skin test in outpatient | – | Other: Skin testSkin test in asthmatic children without severe asthma exacerbation in a preceding year |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Other serious systemic diseases, pregnant, lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin testDemographic data review, Disease severity evaluation, Treatment evaluation and Skin prick test for 16 common aeroallergens | Other | Skin test in severe asthma exacerbation, skin test in outpatient |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Mahidol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between mold sensitization and severe asthma exacerbation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.