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

Immediate Hypersensitivity Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561390
• Other study ID #: Si521/2013
• Status: Completed
• Phase: N/A
• First received: September 15, 2015
• Last updated: May 2, 2016
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypersensitivity
• Hypersensitivity, Immediate
• Immediate Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

Vichyanond P, Jirapongsananuruk O, Visitsuntorn N, Tuchinda M. Prevalence of asthma, rhinitis and eczema in children from the Bangkok area using the ISAAC (International Study for Asthma and Allergy in Children) questionnaires. J Med Assoc Thai. 1998 Mar;81(3):175-84. — View Citation

Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. Lancet. 1998 Apr 25;351(9111):1225-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean wheal diameter of SPT of local and imported allergen extracts and specific IgE levels	measure and compare SPT result of local and imported allergen extracts	18 months	Yes