Rhinitis, Allergic, PerennialDSPTNCT01172613
Optimal Concentration of Dermatophagoides Pteronyssinus (Dp) Allergen Extract for Skin Prick Test (SPT) of Thai Population
An observational study of Rhinitis, Allergic, Perennial and Rhinitis, Allergic, Seasonal, run by Siriraj Hospital at 2 sites in Thailand.
Trial summary
The purpose of this study is to determine the appropriate concentration of diagnostic reagent of house dust mite (Dp) to be used in diagnostic allergy skin prick test among Thai population with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Skin Prick Test
- How many people
- 110 participants
- Where
- 2 sitesThailand
- Study dates
- Jun 2010to Dec 2010
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: allergic rhinitis patients in Siriraj hospital (tertiary care) control group: healthy subjects from community sample
Who may be able to join
- clinical diagnosis of allergic rhinitis
- has skin prick test positive to standard Dp extract (wheal diameter 3 mm. or greater)
- not take any medications that interfere the tests (skin prick test and nasal allergen provocation test)
- no underlying disease
- not take any medications that interfere the tests (skin prick test and nasal allergen provocation test)
Who cannot join
- has skin prick test positive to standard Dp extract with wheal diameter more than 10 mm.
- has chronic disease eg. HIV infection, neurological diseases, hypertension, cardiac diseases, pulmonary diseases, hepatobiliary diseases, renal diseases, endocrinological diseases, congenital malformation, malignancy
- if has asthma, uncontrolled asthma symptom or PEF < 70%
- during pregnancy or lactation
- has chronic skin disease
- participate other project within 30 days
- has abnormal anatomy of the nose
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
Siriraj Hospital
Bangkok, 10700
Professor Pakit Vichyanond, MD, 662-419-7000 ext. 9465-6, pakitv@gmail.com
Parawee Prottasan, MD, 662-419-7000 ext. 5670, 5889, Parawee_p@hotamail.co,
- Recruiting
Siriraj Hospital
Bangkok, 10700
Professor Pakit Vichyanond, MD, 662-419-7000 ext. 9465-6, pakitv@gmail.com
Parawee Prottasan, MD, 662-419-7000 ext. 5670, 5889, Parawee_p@hotmail.com
About this study
Official title: Optimal Concentration of Allergen Extract of Dermatophagoides Pteronyssinus to be Used in Diagnostic Allergy Skin Prick Test Among Thai Population
The purpose of this study is to determine the appropriate concentration of diagnostic reagent of house dust mite (Dp) to be used in diagnostic allergy skin prick test among Thai population with allergic rhinitis.
Read the detailed description
The current allergy diagnostic reagent of house dust mites marketed in the USA is at 10,000 AU/ml. This is based on the IDEAL50 concept put forth by Turkeltaub et al, almost 3 decades ago. Such concentration has been shown to give large degree of false positives even in the US population.
In Thailand, it was anecdotally observed that at such concentration, sizes of positive tests among atopic subjects were quite large and could lead to discomfort and a possible anaphylaxis in certain allergic individuals. Moreover, up to 40% of normal individuals could give positive reaction to this concentration.
It is therefore desirable to reexamine the appropriate concentration of diagnostic reagent of house dust mites among the Thai population and will be the main objective of this research.
- Keywords
- allergic rhinitis, concentration of diagnostic reagent, allergen extract, house dust mites (Dp), skin prick test, nasal allergen provocation test
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects no symptoms | Not described | |
| allergic rhinitis patient | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
appropriate concentration of diagnostic reagent of house dust mite (Dp)
to determine appropriate dilutional concentration of diagnostic reagent of house dust mite (Dp) that has high sensitivity and positive predictive value and wheal size not more than 10 mm. to be used in diagnosis allergic rhinitis in Thai population by skin prick test.
Measured: 15 minutes
Secondary outcomes (2)
false positive rates of various dilutions of diagnostic reagent (house dust mite: Dp) that be used in skin prick test in Thai healthy population
Measured: 15 minutes
false negative rates of various dilutions of diagnostic reagent (house dust mite: Dp) that be used for diagnosis allergic rhinitis in Thai population by skin prick test
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Professor Pakit Vichyanond, MD, Principal investigator, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172613
- Sponsor's protocol ID
- 112/2553(EC3)
- Acronym
- DSPT
- Status last verified
- Jul 2010
- First submitted
- 29 Jul 2010
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Concentration of Allergen Extract of Dermatophagoides Pteronyssinus to be Used in Diagnostic Allergy Skin Prick Test Among Thai Population
- ClinicalTrials.gov ID
- NCT01172613
- Acronym / sponsor ID
- DSPT / 112/2553(EC3)
- Keywords
- allergic rhinitis, concentration of diagnostic reagent, allergen extract, house dust mites (Dp), skin prick test, nasal allergen provocation test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (estimated)
- First posted
- 30 Jul 2010 (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 appropriate concentration of diagnostic reagent of house dust mite (Dp) to be used in diagnostic allergy skin prick test among Thai population with allergic rhinitis.
Detailed description
The current allergy diagnostic reagent of house dust mites marketed in the USA is at 10,000 AU/ml. This is based on the IDEAL50 concept put forth by Turkeltaub et al, almost 3 decades ago. Such concentration has been shown to give large degree of false positives even in the US population.
In Thailand, it was anecdotally observed that at such concentration, sizes of positive tests among atopic subjects were quite large and could lead to discomfort and a possible anaphylaxis in certain allergic individuals. Moreover, up to 40% of normal individuals could give positive reaction to this concentration.
It is therefore desirable to reexamine the appropriate concentration of diagnostic reagent of house dust mites among the Thai population and will be the main objective of this research.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy subjects no symptoms | – | – |
| allergic rhinitis patient | – | – |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- allergic rhinitis patients in Siriraj hospital (tertiary care) control group: healthy subjects from community sample
Key inclusion criteria (5 listed)
- clinical diagnosis of allergic rhinitis
- has skin prick test positive to standard Dp extract (wheal diameter 3 mm. or greater)
- not take any medications that interfere the tests (skin prick test and nasal allergen provocation test)
- no underlying disease
- not take any medications that interfere the tests (skin prick test and nasal allergen provocation test)
Key exclusion criteria (7 listed)
- has skin prick test positive to standard Dp extract with wheal diameter more than 10 mm.
- has chronic disease eg. HIV infection, neurological diseases, hypertension, cardiac diseases, pulmonary diseases, hepatobiliary diseases, renal diseases, endocrinological diseases, congenital malformation, malignancy
- if has asthma, uncontrolled asthma symptom or PEF < 70%
- during pregnancy or lactation
- has chronic skin disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
appropriate concentration of diagnostic reagent of house dust mite (Dp)
Time frame: 15 minutes
to determine appropriate dilutional concentration of diagnostic reagent of house dust mite (Dp) that has high sensitivity and positive predictive value and wheal size not more than 10 mm. to be used in diagnosis allergic rhinitis in Thai population by skin prick test.
2 secondary outcomes
false positive rates of various dilutions of diagnostic reagent (house dust mite: Dp) that be used in skin prick test in Thai healthy population
Time frame: 15 minutes
false negative rates of various dilutions of diagnostic reagent (house dust mite: Dp) that be used for diagnosis allergic rhinitis in Thai population by skin prick test
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2010.
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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.
Professor Pakit Vichyanond, MD principal investigator
Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, Allergic, Perennial and Rhinitis, Allergic, Seasonal, run by Siriraj Hospital at 2 sites 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Professor Pakit Vichyanond, MD (02-419-9465-6, pakitv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
appropriate concentration of diagnostic reagent of house dust mite (Dp) (time frame: 15 minutes). 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 30 Jul 2010.