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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00172341 |
Asthma, the airway inflammatory disorder, is an important chronic disease in children. About 10~15% children are bothered with this. Allergens, such as house-dust mites (HDM), animal dander (i.e. cats and dogs), and seasonal pollens, are often implicated as causative and triggering factors of respiratory attacks in children with asthma. Among them, mites are the most common indoor allergen associated with asthma worldwide.
It appears that SLIT is somewhat effective and safe. However, on the current evidence, further studies are needed to define the indications, the duration of treatment and therapeutic optimal dose of standardized allergen extracts in relation to efficacy and side effects before it is recommended for routine clinical use. The objective of the present study was to investigate the effects and safety of StaloralTM, the standardized extracts of D. pt. and D. f., in asthmatic children allergic to HDM.
Condition | Intervention | Phase |
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Asthma |
Drug: Staloral TM |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Sublingual Immunotherapy With House Dust Mite Extract in Asthmatic Children: A Double-Blind, Randomized, and Placebo-Controlled Study |
Ages Eligible for Study: | 5 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Perennial allergenic asthma and co-sensitization to Cockroach, Alternaria or Cladosporium, dog and/or cat dander and seasonal asthma due to pollens. The co-sensitization involved are established by: - Pertinent clinical history- Positive skin prick test (wheal ³5mm)- Specific IgE rate
Contact: Li-Chieh Wang, MD | 886-2-23123456 ext 5127 | lcwang5@ha.mc.ntu.edu.tw |
Principal Investigator: | Li-Chieh Wang, MD | National Taiwan University Hospital |
Study ID Numbers: | 930309 |
Study First Received: | September 12, 2005 |
Last Updated: | November 2, 2005 |
ClinicalTrials.gov Identifier: | NCT00172341 History of Changes |
Health Authority: | Taiwan: Department of Health |
Asthma |