Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais

March 14, 2019 updated by: Pongsakorn Tantilipikorn

Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis

The purpose of this study is to study the efficacy of allergen injection immunotherapy for allergic rhinitis by

  • symptoms score
  • medication score
  • quality of life
  • immunologic test from blood

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Compare the efficacy of allergen injection immunotherapy between the treatment group and the placebo group after injection for

  • 2 months
  • 6 months
  • 12 months

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 4

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, Thailand, 10700
        • Division of Allergy and Rhinology, Faculty of Medicine Siriraj, Mahidol University

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with the symptoms of allergic rhinitis who sensitized to mite (Dermatophagoides pteronyssinus)
  • positive skin prick test to D.p. at 4+ degree

Exclusion Criteria:

  • steroid dependent asthma
  • force expiratory volume (FEV1) less than 70% of predicted value
  • previous injection immunotherapy within 2 years
  • pregnancy
  • medical conditions such as ischemic heart disease, autoimmune disease, cancer, previous history of anaphylaxis

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
injection by Mite extract with standard allergic medication (oral antihistamine and/or topical nasal steroid)
Biological: Intervention
Dermatophagoides pteronyssinus from ALK company
Other Names:
  • Mite allergen extract (D.p) from ALK company. 10,000 AU/ml
Other: Control Group
Injection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid
Other: Control
Injection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total nasal symptoms score
Time Frame: average within 1 week

3 point scale (0,1,2,3) and combination of

  • nasal block
  • rhinorrhea
  • itching
  • sneezing
average within 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined total symptoms score and medication score
Time Frame: average within 1 week
Total symptom score (nasal block, rhinorrhea, itching, sneezing, and eye symptoms with chest symptoms = Maximal score --> 18 devided by 6 = 3) PLUS medication score ( antihistamine = 1, topical nasal steroid = 2; --> Maximal score = 3).
average within 1 week

Collaborators and Investigators

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

Sponsor

Pongsakorn Tantilipikorn

Collaborators

National Research Council of Thailand

Investigators

  • Principal Investigator: Pongsakorn Tantilipikorn, M.D., Division of Allergy and Rhinology, Faculty of Medicine Siriraj, Mahidol University

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

March 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

May 1, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 336/2552

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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