Optimal Concentration of Dermatophagoides Pteronyssinus (... | NCT01172613

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

NCT01172613

Sponsor

Siriraj Hospital

Status

Unknown status

Last Update Posted

Jul 30, 2010Estimated

Enrollment

110Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Dec 2010Estimated

Completion Date

Not provided

First Submitted Date

Jul 29, 2010

First Submission Date that Met QC Criteria

Jul 29, 2010

First Posted Date

Jul 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2010

Last Update Posted Date

Jul 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Professor Pakit Vichyanond, MD	Contact	02-419-9465-6		pakitv@gmail.com
Parawee Prottasan, MD	Contact	02-419-5670, 5889		Parawee_p@hotmail.com

Overall Officials

Name	Affiliation	Role
Professor Pakit Vichyanond, MD	Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Siriraj Hospital	Recruiting	Bangkok		10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D012221	Rhinitis, Allergic, Perennial
D006255	Rhinitis, Allergic, Seasonal
D065631	Rhinitis, Allergic

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided