Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais

Rhinitis, Allergic, Perennial Clinical Trial

Official title:

Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115595
• Other study ID #: 336/2552
• Status: Completed
• Phase: Phase 4
• Start date: March 2010
• Est. completion date: October 2014

Study information

• Verified date: March 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Biological:
• Intervention
Dermatophagoides pteronyssinus from ALK company

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

Locations

Country	Name	City	State
Thailand	Division of Allergy and Rhinology, Faculty of Medicine Siriraj, Mahidol University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Pongsakorn Tantilipikorn	National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total nasal symptoms score	3 point scale (0,1,2,3) and combination of; nasal block; rhinorrhea; itching; sneezing	average within 1 week
Secondary	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