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Completed

NCT Number: NCT01115595

Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais

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

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Key information

Conditions

Rhinitis, Allergic, Perennial Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Bangkok, 10700, Thailand

About this study

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

  • 2 months
  • 6 months
  • 12 months

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Biological

Dermatophagoides pteronyssinus from ALK company

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

Control

Other

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

Primary outcomes

  1. Total nasal symptoms score

    Time frame: average within 1 week

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

    • nasal block
    • rhinorrhea
    • itching
    • sneezing

Secondary outcomes

  1. Combined total symptoms score and medication score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Pongsakorn Tantilipikorn

Other

Collaborators

  • National Research Council of Thailand

Registry information

Official study title

Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
May 4, 2010
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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