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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. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Siriraj Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01172613
First Posted: July 30, 2010
Last Update Posted: July 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Siriraj Hospital
  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

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 ]
    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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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)
First Submitted: July 29, 2010
First Posted: July 30, 2010
Last Update Posted: July 30, 2010
Last Verified: July 2010

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
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases