Comparison Between spIgE and Skin Prick Test of Local and Imported Aeroallergens

May 2, 2016 updated by: Nualanong Visitsunthorn, Mahidol University

In-vivo Potency Evaluation of American Cockroach, Dog, Cat, Dust Mites and Mold Allergen Extracts Produced by Siriraj Hospital Comparing With Imported Extracts by Using Skin Prick Test.

The prevalence of Allergic rhinitis(AR) and asthma was increased world wide. In 1998, ISAAC found that prevalence of AR and asthma inThailand was in moderately high group.

Tests for immediated reaction SPT and spIgE, were used for evaluated sensitization of allergen in patient. They guided the investigators for proper management as well as patient education. Clinician will use the result for choose allergen in case that might need immunotherapy.

SPT is safe and more economic for patient. Specific IgE has an advantage in patient who cannot withhold antihistamine prior SPT. In United state had a trial of result between SPT and spIgE for cockroach, cat, house dust mite and mold. It showed the correlation between two tests. In Thailand, the investigators haven't had data about it yet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

SPT and specific IgE for allergens is necessary for allergen avoidance and specific immunotherapy. To have local allergen extracts will help the patients to easier get the appropriate management

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with controlled Asthma and/or AR (mild to moderate severity) who were diagnosed in Allergy clinic and ENT clinic, Siriraj hospital
  • SPT positve one of American Cockroach, House dust mite, cat, dog and mold.
  • Patient were consented to trial.

Exclusion Criteria:

  • Chronic disease such as heart disease, liver, renal and severe sepsis
  • History of anaphylaxis
  • Skin rash
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin prick test with aeroallergens
Mean wheal diameters of SPT with commercial and local American coakroach, house dust mite, cat, dog and mold
Procedure: Skin prick test
skin prick test to American cockroach, dog, cat, dust mite and mold allergen extracts are performed
Other: specific IgE measurement
measure specific IgE of American cockroach, dog, cat, dust mite and mold
Experimental: specific IgE measurement
specific IgE levels of commercial and local American coakroach, house dust mite, cat, dog and mold
Procedure: Skin prick test
skin prick test to American cockroach, dog, cat, dust mite and mold allergen extracts are performed
Other: specific IgE measurement
measure specific IgE of American cockroach, dog, cat, dust mite and mold

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean wheal diameter of SPT of local and imported allergen extracts and specific IgE levels
Time Frame: 18 months
measure and compare SPT result of local and imported allergen extracts
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Nualanong Visitsunthorn, Prof, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimate)

September 28, 2015

Study Record Updates

Last Update Posted (Estimate)

May 4, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si521/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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