Optimal Concentration of Dermatophagoides Pteronyssinus (Dp) Allergen Extract for Skin Prick Test (SPT) of Thai Population

Rhinitis, Allergic, Seasonal Clinical Trial

— DSPT  

Official title:

Optimal Concentration of Allergen Extract of Dermatophagoides Pteronyssinus to be Used in Diagnostic Allergy Skin Prick Test Among Thai Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01172613
• Other study ID #: 112/2553(EC3)
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 29, 2010
• Last updated: July 29, 2010
• Start date: June 2010

Study information

• Verified date: July 2010
• Source: Siriraj Hospital
• Contact: Professor Pakit Vichyanond, MD
• Phone: 02-419-9465-6
• Email: pakitv[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Perennial
• Rhinitis, Allergic, Seasonal
• Skin Prick Test

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes	No
Secondary	false positive rates of various dilutions of diagnostic reagent (house dust mite: Dp) that be used in skin prick test in Thai healthy population		15 minutes	No
Secondary	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		15 minutes	No