Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Sponsor:
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

July 29, 2010
July 29, 2010
June 2010
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Optimal Concentration of Dermatophagoides Pteronyssinus (Dp) Allergen Extract for Skin Prick Test (SPT) of Thai Population
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

allergic rhinitis patients in Siriraj hospital (tertiary care) control group: healthy subjects from community sample

  • Rhinitis, Allergic, Perennial
  • Rhinitis, Allergic, Seasonal
  • Skin Prick Test
Not Provided
  • healthy subjects no symptoms
  • allergic rhinitis patient
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
Not Provided
December 2010   (final data collection date for primary outcome measure)

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
Both
15 Years to 60 Years
Yes
Contact: Professor Pakit Vichyanond, MD 02-419-9465-6 pakitv@gmail.com
Contact: Parawee Prottasan, MD 02-419-5670, 5889 Parawee_p@hotmail.com
Thailand
 
NCT01172613
112/2553(EC3)
No
Professor Pakit Vichyanond, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Siriraj Hospital
Not Provided
Principal Investigator: Professor Pakit Vichyanond, MD Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Siriraj Hospital
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP