Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais

NCT ID: NCT01115595

Last Updated: 2019-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-10-31

Brief Summary

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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

Detailed Description

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

* 2 months
* 6 months
* 12 months

Conditions

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Rhinitis, Allergic, Perennial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

injection by Mite extract with standard allergic medication (oral antihistamine and/or topical nasal steroid)

Group Type ACTIVE_COMPARATOR

Intervention

Intervention Type BIOLOGICAL

Dermatophagoides pteronyssinus from ALK company

Control Group

Injection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid

Group Type OTHER

Control

Intervention Type OTHER

Injection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid)

Interventions

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Intervention

Dermatophagoides pteronyssinus from ALK company

Intervention Type BIOLOGICAL

Control

Injection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid)

Intervention Type OTHER

Other Intervention Names

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Mite allergen extract (D.p) from ALK company. 10,000 AU/ml

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Council of Thailand

OTHER_GOV

Sponsor Role collaborator

Pongsakorn Tantilipikorn

OTHER

Sponsor Role lead

Responsible Party

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Pongsakorn Tantilipikorn

Associate Professor Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pongsakorn Tantilipikorn, M.D.

Role: PRINCIPAL_INVESTIGATOR

Division of allergy and rhinology, Faculty of Medicine Siriraj, Mahidol University

Locations

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Division of Allergy and Rhinology, Faculty of Medicine Siriraj, Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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336/2552

Identifier Type: -

Identifier Source: org_study_id

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