Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais

The recruitment status of this study is unknown because the information has not been verified recently.
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

May 1, 2010
August 2, 2011
March 2010
March 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01115595 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais
Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis

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

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

  • 2 months
  • 6 months
  • 12 months
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rhinitis, Allergic, Perennial
Biological: Mite allergen extract
Dermatophagoides pteronyssinus from ALK company
Other Name: Allegen extract (D.p) from ALK company. 10,000 AU/ml
No Intervention: Placebo injection
Placebo injection with standard medication (oral antihistamine and/or topical nasal steroid)
Intervention: Biological: Mite allergen extract
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact: Pongsakorn Tantilipikorn, M.D. +66 2 419 7409 siptv@mahidol.ac.th
Contact: Bangon Pinkaew, M.Sc. +66 2 4197409 sispi@mahidol.ac.th
Thailand
 
NCT01115595
336/2552
Yes
National Research Council of Thailand
Mahidol University
National Research Council of Thailand
Principal Investigator: Pongsakorn Tantilipikorn, M.D. Division of allergy and rhinology, Faculty of Medicine Siriraj, Mahidol University
Mahidol University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP