Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais

Phase 4

Completed

• Conditions: Rhinitis, Allergic, Perennial
• Interventions: Other: Control; Biological: Intervention

• Registration Number: NCT01115595
• Lead Sponsor: Pongsakorn Tantilipikorn

Brief Summary

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

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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-05-01
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Primary Completion: 2013-10
• Study Completion: 2014-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control Group	Control	Injection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid
Intervention	Intervention	injection by Mite extract with standard allergic medication (oral antihistamine and/or topical nasal steroid)

Primary Outcome Measures

Name	Time	Method
Total nasal symptoms score	average within 1 week	3 point scale (0,1,2,3) and combination of; * nasal block; * rhinorrhea; * itching; * sneezing

Secondary Outcome Measures

Name	Time	Method
Combined total symptoms score and medication score	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).

Trial Locations

Locations (1)

Division of Allergy and Rhinology, Faculty of Medicine Siriraj, Mahidol University; 🇹🇭 Bangkok, Thailand