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

• Conditions: Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Skin Prick Test

• Registration Number: NCT01172613
• Lead Sponsor: Siriraj Hospital

Brief 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.

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 Timeline

• Study Start: 2010-06
• Status Verified: 2010-07
• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-07-29
• Last Update Submitted: 2010-07-29
• Study First Posted: 2010-07-30
• Last Update Posted: 2010-07-30
• Primary Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
appropriate concentration of diagnostic reagent of house dust mite (Dp)	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.

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand