Immediate Type HypersensitivityNCT02764827
Comparison of Skin Prick Testing Results of Local and Imported Pollen Allergen Extracts and Specific IgE
An observational study of Immediate Type Hypersensitivity, run by Mahidol University.
Trial summary
Pollen allergen extracts are prepared locally and checked for efficacy by comparison to imported allergens and specific IgE. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Type Hypersensitivity
- What is being tested?
- Pollen sensitization
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Apr 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: People 18-60 years of age who recently have positive skin prick test to grass pollen or careless weed are pricked with local and imported Bermuda grass, Johnson grass and careless weed allergen extracts. Specific IgE levels are also measured at the same day.
Who may be able to join
- Positive skin prick test to Bermuda or Johnson or careless weed
Who cannot join
- Chronic diseases such as heart disease, liver, renal and severe sepsis
- Severe allergic symptoms such as anaphylaxis
- Extensive skin rashes
- Pregnancy
About this study
Official title: Comparison of Skin Prick Testing Results of Local and Imported Pollen Allergen Extracts (Bermuda ,Johnson Grasses and Careless Weed) With Specific IgE Levels.
Pollen allergen extracts are prepared locally and checked for efficacy by comparison to imported allergens and specific IgE.
Read the detailed description
Skin prick test (SPT) and specific IgE (sIgE) are approved for evaluation of allergen sensitization. Local allergen extracts are cheaper and more available but need standardization. Pollen allergen extracts: Bermuda, Johnson and careless weed are locally prepared and compared mean wheal diameter of skin prick test to imported allergens and also to specific IgE.
- Conditions
- Immediate Type Hypersensitivity
- Being tested
- Pollen sensitization
- Keywords
- skin prick test, grass and weed pollens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pollen sensitizationBiological
Skin prick test with local and imported Bermuda, Johnson and careless weed allergen extracts at concentration of 10,000, 3,000, 1,000 and 300 AU/mL and measure specific IgE levels
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean wheal diameter of local and imported grass and weed pollens
compare mean wheal diameter of skin prick test of different concentration among local, imported allergen extract and specific IgE levels of Bermuda grass, Johnson grass and careless weed
Measured: 18 months
sIgE levels of Bermuda grass,Johnson grass and careless weed
Measure level of sIgE of Bermuda grass,Johnson grass and careless weed and compare to SPT results
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 posted6 May 2016 (estimated)
- Study startNov 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Type 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 68 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
- NCT02764827
- Sponsor's protocol ID
- Si246/2556
- Status last verified
- May 2016
- First submitted
- 2 May 2016
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Skin Prick Testing Results of Local and Imported Pollen Allergen Extracts (Bermuda ,Johnson Grasses and Careless Weed) With Specific IgE Levels.
- ClinicalTrials.gov ID
- NCT02764827
- Acronym / sponsor ID
- Si246/2556
- Conditions
- Immediate Type Hypersensitivity
- Keywords
- skin prick test, grass and weed pollens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 May 2016 (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.
Pollen allergen extracts are prepared locally and checked for efficacy by comparison to imported allergens and specific IgE.
Detailed description
Skin prick test (SPT) and specific IgE (sIgE) are approved for evaluation of allergen sensitization. Local allergen extracts are cheaper and more available but need standardization. Pollen allergen extracts: Bermuda, Johnson and careless weed are locally prepared and compared mean wheal diameter of skin prick test to imported allergens and also to specific IgE.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- People 18-60 years of age who recently have positive skin prick test to grass pollen or careless weed are pricked with local and imported Bermuda grass, Johnson grass and careless weed allergen extracts. Specific IgE levels are also measured at the same day.
Key inclusion criteria (1 listed)
- Positive skin prick test to Bermuda or Johnson or careless weed
Key exclusion criteria (4 listed)
- Chronic diseases such as heart disease, liver, renal and severe sepsis
- Severe allergic symptoms such as anaphylaxis
- Extensive skin rashes
- 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 |
|---|---|---|
| Pollen sensitizationSkin prick test with local and imported Bermuda, Johnson and careless weed allergen extracts at concentration of 10,000, 3,000, 1,000 and 300 AU/mL and measure specific IgE levels | Biological | – |
Primary outcome
Mean wheal diameter of local and imported grass and weed pollens
Time frame: 18 months
compare mean wheal diameter of skin prick test of different concentration among local, imported allergen extract and specific IgE levels of Bermuda grass, Johnson grass and careless weed
sIgE levels of Bermuda grass,Johnson grass and careless weed
Time frame: 18 months
Measure level of sIgE of Bermuda grass,Johnson grass and careless weed and compare to SPT results
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 10 May 2016.
- 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.
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 Immediate Type Hypersensitivity, 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 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 10 May 2016. 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?
Mean wheal diameter of local and imported grass and weed pollens (time frame: 18 months). The study lists 2 primary outcomes in all. 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 10 May 2016.