Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts

Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts in Respiratory Allergy Patients

In respiratory allergy patients, skin prick test results of local rat and mouse allergen extracts are not significant different from imported ones

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis Due to Animal Hair and Dander
• Intervention / Treatment: Diagnostic test: rat and mouse skin test

Detailed Description

Many researches proposed that rodent deteriorate symptoms in patients with respiratory allergy who sensitized. The test that can identify rodent sensitization will be very useful. The investigators found lots of problems from imported mouse and rat allergen extract, eg. expensive cost and hard to find importing agency in Thailand. Making own local allergen extract will be the good solution for the country. This study aim to compare the results of locally rat and mouse allergen to imported ones.

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital. Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 56 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients age 3 to 60 years old who diagnosed with asthma or allergic rhinitis
• Patient must not take these following medication at least 7 days before doing the skin prick test: antihistamine, oral corticosteroid (more than 20 mg/day of prednisolone), topical steroid that was apply on skin test area.

Exclusion Criteria:

• Pateints who have other chronic underlying disease e.g. obesity, heart disease and liver disease
• Patient with allergic asthma who is still uncontrollable.
• Patient with active severe atopic dermatitis
• Patient who are pregnant or in lactating period
• Patient or parent deny to join in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Local rat and mouse skin test; All patients receive local skin prick test for mouse and rat. The result were recorded and compared to the imported one.	Diagnostic test: rat and mouse skin test; Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients
Active Comparator: Imported rat and mouse skin test; All patients receive imported skin prick test for mouse and rat. The result were recorded and compared to the local one.	Diagnostic test: rat and mouse skin test; Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients	Compare the results of locally rat and mouse allergen to imported ones.	1 year

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: 789/2560 (EC 2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No