Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais
Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis
1 other identifier
interventional
84
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2010
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 1, 2010
CompletedFirst Posted
Study publicly available on registry
May 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedMarch 18, 2019
March 1, 2019
3.6 years
May 1, 2010
March 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total nasal symptoms score
3 point scale (0,1,2,3) and combination of * nasal block * rhinorrhea * itching * sneezing
average within 1 week
Secondary Outcomes (1)
Combined total symptoms score and medication score
average within 1 week
Study Arms (2)
Intervention
ACTIVE COMPARATORinjection by Mite extract with standard allergic medication (oral antihistamine and/or topical nasal steroid)
Control Group
OTHERInjection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid
Interventions
Dermatophagoides pteronyssinus from ALK company
Injection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid)
Eligibility Criteria
You may qualify if:
- patients with the symptoms of allergic rhinitis who sensitized to mite (Dermatophagoides pteronyssinus)
- positive skin prick test to D.p. at 4+ degree
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pongsakorn Tantilipikornlead
- National Research Council of Thailandcollaborator
Study Sites (1)
Division of Allergy and Rhinology, Faculty of Medicine Siriraj, Mahidol University
Bangkok, 10700, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pongsakorn Tantilipikorn, M.D.
Division of allergy and rhinology, Faculty of Medicine Siriraj, Mahidol University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor Dr.
Study Record Dates
First Submitted
May 1, 2010
First Posted
May 4, 2010
Study Start
March 1, 2010
Primary Completion
October 1, 2013
Study Completion
October 1, 2014
Last Updated
March 18, 2019
Record last verified: 2019-03