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Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais

Primary Purpose

Rhinitis, Allergic, Perennial

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Control

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Perennial focused on measuring Allergic rhinitis, Allergen injection immunotherapy, Efficacy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Intervention

Control Group

Arm Description

injection by Mite extract with standard allergic medication (oral antihistamine and/or topical nasal steroid)

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

Outcomes

Primary Outcome Measures

Total nasal symptoms score

3 point scale (0,1,2,3) and combination of nasal block rhinorrhea itching sneezing

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT01115595

First Posted

May 1, 2010

Last Updated

March 14, 2019

Sponsor

Pongsakorn Tantilipikorn

Collaborators

National Research Council of Thailand

1. Study Identification

Unique Protocol Identification Number

NCT01115595

Brief Title

Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais

Official Title

Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Pongsakorn Tantilipikorn

Collaborators

National Research Council of Thailand

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis, Allergic, Perennial

Keywords

Allergic rhinitis, Allergen injection immunotherapy, Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Active Comparator

Arm Description

injection by Mite extract with standard allergic medication (oral antihistamine and/or topical nasal steroid)

Arm Title

Control Group

Arm Type

Other

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Intervention

Other Intervention Name(s)

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

Intervention Description

Dermatophagoides pteronyssinus from ALK company

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

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

Primary Outcome Measure Information:

Title

Total nasal symptoms score

Description

3 point scale (0,1,2,3) and combination of nasal block rhinorrhea itching sneezing

Time Frame

average within 1 week

Secondary Outcome Measure Information:

Title

Combined total symptoms score and medication score

Description

Time Frame

average within 1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pongsakorn Tantilipikorn, M.D.

Organizational Affiliation

Division of allergy and rhinology, Faculty of Medicine Siriraj, Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

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Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais

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