Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais

Study Overview
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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

Official Title
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Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Biological: Intervention
* Other: Control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total nasal symptoms score | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic rhinitis, Allergen injection immunotherapy, Efficacy