AsthmaNCT02531503
Predicting Factors for Asthma Remission in Children
An observational study of Asthma, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine the predicting factors for asthma remission in children. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Asthma
- What is being tested?
- Clinical asthma remission
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2015to Mar 2016
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: The children who were diagnosed as having asthma at pediatric allergy clinic were recruited.
Who may be able to join
- Children who were diagnosed as having asthma during the period of 2004-2007.
Who cannot join
- Patients who had underlying disease with chronic respiratory disease (ex. tuberculosis, bronchiectasis), primary immunodeficiency, other seriously interfering diseases
- Medical records have been lost.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
The purpose of this study is to determine the predicting factors for asthma remission in children.
Read the detailed description
Children who were diagnosed as having asthma during the period of 2004-2007 and reevaluated in 2015.
- Conditions
- Asthma
- Being tested
- Clinical asthma remission
- Keywords
- Asthma remission, Predicting factors, Children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical asthma remissionOther
Clinical asthma remission was defined as having no asthma symptoms and no use of medication during the past 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Clinical asthma remission | Clinical asthma remission was defined as having no asthma symptoms and no use of asthma medication during the past 12 months. Receives: Other: Clinical asthma remission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of factors associated with asthma remission
Measured: 18 months
Secondary outcomes (1)
Asthma remission rate
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionMar 2016
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.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JITTIMA VESKITKUL, Mahidol University
- Investigators
- Division of Allergy and Immunology, Department of Pediatrics,, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531503
- Sponsor's protocol ID
- 697/2557(EC3)
- Status last verified
- Mar 2017
- First submitted
- 19 Aug 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Factors for Asthma Remission in Children
- ClinicalTrials.gov ID
- NCT02531503
- Acronym / sponsor ID
- 697/2557(EC3)
- Conditions
- Asthma
- Keywords
- Asthma remission, Predicting factors, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Aug 2015 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical asthma remission | – | Other: Clinical asthma remissionClinical asthma remission was defined as having no asthma symptoms and no use of asthma medication during the past 12 months. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The children who were diagnosed as having asthma at pediatric allergy clinic were recruited.
Key inclusion criteria (1 listed)
- Children who were diagnosed as having asthma during the period of 2004-2007.
Key exclusion criteria (2 listed)
- Patients who had underlying disease with chronic respiratory disease (ex. tuberculosis, bronchiectasis), primary immunodeficiency, other seriously interfering diseases
- Medical records have been lost.
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 |
|---|---|---|
| Clinical asthma remissionClinical asthma remission was defined as having no asthma symptoms and no use of medication during the past 12 months. | Other | Clinical asthma remission |
Primary outcome
Number of factors associated with asthma remission
Time frame: 18 months
1 secondary outcome
Asthma remission rate
Time frame: 18 months
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 22 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Division of Allergy and Immunology, Department of Pediatrics, principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Mahidol University at 1 site in Thailand.
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 2 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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of factors associated with asthma remission (time frame: 18 months). 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 22 Mar 2017.