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Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais

Phase 4
Completed
Conditions
Rhinitis, Allergic, Perennial
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

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
Primary Outcome Measures
NameTimeMethod
Total nasal symptoms scoreaverage within 1 week

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

* nasal block

* rhinorrhea

* itching

* sneezing

Secondary Outcome Measures
NameTimeMethod
Combined total symptoms score and medication scoreaverage 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

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

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