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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 23, 2014