Immediate HypersensitivityNCT02561390
Comparison Between spIgE and Skin Prick Test of Local and Imported Aeroallergens
A study testing Skin prick test and specific IgE measurement in people with Immediate Hypersensitivity, run by Mahidol University at 1 site in Thailand.
Trial summary
The prevalence of Allergic rhinitis(AR) and asthma was increased world wide. In 1998, ISAAC found that prevalence of AR and asthma inThailand was in moderately high group. Tests for immediated reaction SPT and spIgE, were used for evaluated sensitization of allergen in patient. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Immediate Hypersensitivity
- What is being tested?
- Skin prick test and specific IgE measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2013to Jun 2014
- Phase
- Interventional
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient with controlled Asthma and/or AR (mild to moderate severity) who were diagnosed in Allergy clinic and ENT clinic, Siriraj hospital
- SPT positve one of American Cockroach, House dust mite, cat, dog and mold.
- Patient were consented to trial.
Who cannot join
- Chronic disease such as heart disease, liver, renal and severe sepsis
- History of anaphylaxis
- Skin rash
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
Official title: In-vivo Potency Evaluation of American Cockroach, Dog, Cat, Dust Mites and Mold Allergen Extracts Produced by Siriraj Hospital Comparing With Imported Extracts by Using Skin Prick Test.
The prevalence of Allergic rhinitis(AR) and asthma was increased world wide. In 1998, ISAAC found that prevalence of AR and asthma inThailand was in moderately high group.
Tests for immediated reaction SPT and spIgE, were used for evaluated sensitization of allergen in patient. They guided the investigators for proper management as well as patient education. Clinician will use the result for choose allergen in case that might need immunotherapy.
SPT is safe and more economic for patient. Specific IgE has an advantage in patient who cannot withhold antihistamine prior SPT. In United state had a trial of result between SPT and spIgE for cockroach, cat, house dust mite and mold. It showed the correlation between two tests. In Thailand, the investigators haven't had data about it yet.
Read the detailed description
SPT and specific IgE for allergens is necessary for allergen avoidance and specific immunotherapy. To have local allergen extracts will help the patients to easier get the appropriate management
- Conditions
- Immediate Hypersensitivity
- Being tested
- Skin prick test, specific IgE measurement
- Medical subject headings
- Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin prick testProcedure or surgery
skin prick test to American cockroach, dog, cat, dust mite and mold allergen extracts are performed
specific IgE measurementOther
measure specific IgE of American cockroach, dog, cat, dust mite and mold
| Study group | Role | What they receive |
|---|---|---|
| Skin prick test with aeroallergens | Experimental | Mean wheal diameters of SPT with commercial and local American coakroach, house dust mite, cat, dog and mold Receives: Procedure: Skin prick test; Other: specific IgE measurement |
| specific IgE measurement | Experimental | specific IgE levels of commercial and local American coakroach, house dust mite, cat, dog and mold Receives: Procedure: Skin prick test; Other: specific IgE measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean wheal diameter of SPT of local and imported allergen extracts and specific IgE levels
measure and compare SPT result of local and imported allergen extracts
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 posted28 Sep 2015 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immediate HypersensitivityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nualanong Visitsunthorn, Mahidol University
- Investigators
- Nualanong Visitsunthorn, Prof, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561390
- Sponsor's protocol ID
- Si521/2013
- Status last verified
- May 2016
- First submitted
- 15 Sep 2015
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. Lancet. 1998 Apr 25;351(9111):1225-32.
PubMed 9643741Vichyanond P, Jirapongsananuruk O, Visitsuntorn N, Tuchinda M. Prevalence of asthma, rhinitis and eczema in children from the Bangkok area using the ISAAC (International Study for Asthma and Allergy in Children) questionnaires. J Med Assoc Thai. 1998 Mar;81(3):175-84.
PubMed 9623008
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-vivo Potency Evaluation of American Cockroach, Dog, Cat, Dust Mites and Mold Allergen Extracts Produced by Siriraj Hospital Comparing With Imported Extracts by Using Skin Prick Test.
- ClinicalTrials.gov ID
- NCT02561390
- Acronym / sponsor ID
- Si521/2013
- Conditions
- Immediate Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Sep 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 prevalence of Allergic rhinitis(AR) and asthma was increased world wide. In 1998, ISAAC found that prevalence of AR and asthma inThailand was in moderately high group.
Tests for immediated reaction SPT and spIgE, were used for evaluated sensitization of allergen in patient. They guided the investigators for proper management as well as patient education. Clinician will use the result for choose allergen in case that might need immunotherapy.
SPT is safe and more economic for patient. Specific IgE has an advantage in patient who cannot withhold antihistamine prior SPT. In United state had a trial of result between SPT and spIgE for cockroach, cat, house dust mite and mold. It showed the correlation between two tests. In Thailand, the investigators haven't had data about it yet.
Detailed description
SPT and specific IgE for allergens is necessary for allergen avoidance and specific immunotherapy. To have local allergen extracts will help the patients to easier get the appropriate management
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin prick test with aeroallergens | Experimental | Procedure: Skin prick test, Other: specific IgE measurementMean wheal diameters of SPT with commercial and local American coakroach, house dust mite, cat, dog and mold |
| specific IgE measurement | Experimental | Procedure: Skin prick test, Other: specific IgE measurementspecific IgE levels of commercial and local American coakroach, house dust mite, cat, dog and mold |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient with controlled Asthma and/or AR (mild to moderate severity) who were diagnosed in Allergy clinic and ENT clinic, Siriraj hospital
- SPT positve one of American Cockroach, House dust mite, cat, dog and mold.
- Patient were consented to trial.
Key exclusion criteria (4 listed)
- Chronic disease such as heart disease, liver, renal and severe sepsis
- History of anaphylaxis
- Skin rash
- Pregnancy
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 prick testskin prick test to American cockroach, dog, cat, dust mite and mold allergen extracts are performed | Procedure or surgery | Skin prick test with aeroallergens, specific IgE measurement |
| specific IgE measurementmeasure specific IgE of American cockroach, dog, cat, dust mite and mold | Other | Skin prick test with aeroallergens, specific IgE measurement |
Primary outcome
mean wheal diameter of SPT of local and imported allergen extracts and specific IgE levels
Time frame: 18 months
measure and compare SPT result of local and imported allergen extracts
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 4 May 2016.
- Background: PubMed 9643741Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. Lancet. 1998 Apr 25;351(9111):1225-32.
- Background: PubMed 9623008Vichyanond P, Jirapongsananuruk O, Visitsuntorn N, Tuchinda M. Prevalence of asthma, rhinitis and eczema in children from the Bangkok area using the ISAAC (International Study for Asthma and Allergy in Children) questionnaires. J Med Assoc Thai. 1998 Mar;81(3):175-84.
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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.
Nualanong Visitsunthorn, Prof 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?
A study testing Skin prick test and specific IgE measurement in people with Immediate Hypersensitivity, 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 3 inclusion and 4 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 4 May 2016. 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?
mean wheal diameter of SPT of local and imported allergen extracts and specific IgE levels (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02561390, which also lists 2 linked publications.
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 4 May 2016.