Optimal Concentration of Dermatophagoides Pteronyssinus (Dp) Allergen Extract for Skin Prick Test (SPT) of Thai Population (DSPT)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Siriraj Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Siriraj Hospital
Information provided by:
Siriraj Hospital
ClinicalTrials.gov Identifier:
NCT01172613
First received: July 29, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Phase |
|---|---|
|
Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Skin Prick Test |
Phase 2 Phase 3 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Optimal Concentration of Allergen Extract of Dermatophagoides Pteronyssinus to be Used in Diagnostic Allergy Skin Prick Test Among Thai Population |
Resource links provided by NLM:
Further study details as provided by Siriraj Hospital:
Primary Outcome Measures:
- appropriate concentration of diagnostic reagent of house dust mite (Dp) [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | June 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| healthy subjects no symptoms |
| allergic rhinitis patient |
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.
Eligibility| Ages Eligible for Study: | 15 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
allergic rhinitis patients in Siriraj hospital (tertiary care) control group: healthy subjects from community sample
Criteria
Inclusion Criteria:allergic rhinitis
- 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)
Inclusion Criteria:healthy subject
- no underlying disease
- not take any medications that interfere the tests (skin prick test and nasal allergen provocation test)
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172613
Contacts
| Contact: Professor Pakit Vichyanond, MD | 02-419-9465-6 | pakitv@gmail.com |
| Contact: Parawee Prottasan, MD | 02-419-5670, 5889 | Parawee_p@hotmail.com |
Locations
| Thailand | |
| Siriraj Hospital | Recruiting |
| Bangkok, Thailand, 10700 | |
| Contact: Professor Pakit Vichyanond, MD 662-419-7000 ext 9465-6 pakitv@gmail.com | |
| Contact: Parawee Prottasan, MD 662-419-7000 ext 5670, 5889 Parawee_p@hotamail.co, | |
| Siriraj Hospital | Recruiting |
| Bangkok, Thailand, 10700 | |
| Contact: Professor Pakit Vichyanond, MD 662-419-7000 ext 9465-6 pakitv@gmail.com | |
| Contact: Parawee Prottasan, MD 662-419-7000 ext 5670, 5889 Parawee_p@hotmail.com | |
| Principal Investigator: Professor Pakit Vichyanond, MD | |
| Sub-Investigator: Professor Chaweewan Bunnag, MD | |
| Sub-Investigator: Assistant Professor Pongsakorn Tantilipikorn, MD | |
| Sub-Investigator: Professor Nualanong Visitsunthorn, MD | |
| Sub-Investigator: Associate Professor Orathai Piboonpocanun, MD | |
| Sub-Investigator: Punchama Pacharn, MD | |
| Sub-Investigator: Parawee Prottasan, MD | |
| Sub-Investigator: Triphoom Suwanwech, MD | |
| Sub-Investigator: Chaweewan Sripramong, SC | |
| Sub-Investigator: Unchalee Wangthan, SC | |
Sponsors and Collaborators
Siriraj Hospital
Investigators
| Principal Investigator: | Professor Pakit Vichyanond, MD | Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University |
More Information
No publications provided
| Responsible Party: | Professor Pakit Vichyanond, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University |
| ClinicalTrials.gov Identifier: | NCT01172613 History of Changes |
| Other Study ID Numbers: | 112/2553(EC3) |
| Study First Received: | July 29, 2010 |
| Last Updated: | July 29, 2010 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Siriraj Hospital:
|
allergic rhinitis concentration of diagnostic reagent allergen extract, house dust mites (Dp) skin prick test nasal allergen provocation test |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Rhinitis Rhinitis, Allergic, Perennial Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity |
Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 19, 2013