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Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Mahidol University.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
National Research Council of Thailand
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01115595
First received: May 1, 2010
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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

Condition Intervention Phase
Rhinitis, Allergic, Perennial
Biological: Mite allergen extract
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Total nasal symptoms score [ Time Frame: average within 1 week ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: average within 1 week ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Placebo injection
Placebo injection with standard medication (oral antihistamine and/or topical nasal steroid)
Biological: Mite allergen extract
Dermatophagoides pteronyssinus from ALK company
Other Name: Allegen extract (D.p) from ALK company. 10,000 AU/ml

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
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115595

Locations
Thailand
Division of Allergy and Rhinology, Faculty of Medicine Siriraj, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
National Research Council of Thailand
Investigators
Principal Investigator: Pongsakorn Tantilipikorn, M.D. Division of allergy and rhinology, Faculty of Medicine Siriraj, Mahidol University
  More Information

Responsible Party: National Research Council of Thailand
ClinicalTrials.gov Identifier: NCT01115595     History of Changes
Other Study ID Numbers: 336/2552 
Study First Received: May 1, 2010
Last Updated: August 2, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Allergic rhinitis
Allergen injection immunotherapy
Efficacy

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on December 07, 2016