NCT02561390

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

September 15, 2015

Last Update Submit

May 2, 2016

Conditions

Immediate Hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Skin prick test with aeroallergens

EXPERIMENTAL

Mean wheal diameters of SPT with commercial and local American coakroach, house dust mite, cat, dog and mold

Procedure: Skin prick testOther: specific IgE measurement

specific IgE measurement

EXPERIMENTAL

specific IgE levels of commercial and local American coakroach, house dust mite, cat, dog and mold

Procedure: Skin prick testOther: specific IgE measurement

Interventions

Skin prick testPROCEDURE

skin prick test to American cockroach, dog, cat, dust mite and mold allergen extracts are performed

Skin prick test with aeroallergensspecific IgE measurement
specific IgE measurementOTHER

measure specific IgE of American cockroach, dog, cat, dust mite and mold

Skin prick test with aeroallergensspecific IgE measurement

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 9643741BACKGROUND

  • 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.

    PMID: 9623008BACKGROUND

MeSH Terms

Conditions

Hypersensitivity, Immediate

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

HypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Nualanong Visitsunthorn, Prof

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 28, 2015

Study Start

November 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

TH(1)