Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais

Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01115595

Enrollment

Registered

2010-05-04

Start date

2010-03-31

Completion date

2014-10-31

Last updated

2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic, Perennial

Keywords

Allergic rhinitis, Allergen injection immunotherapy, Efficacy

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

Interventions

BIOLOGICALIntervention

Dermatophagoides pteronyssinus from ALK company

OTHERControl

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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).

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026