Sublingual Immunotherapy With House Dust Mite Extract in Asthmatic Children
Sublingual Immunotherapy With House Dust Mite Extract in Asthmatic Children
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.
Inclusion Criteria:

 -  Patients aged between 5 to 15 years; either sex· Patients with asthma at least one
 year of clinical history and with sensitization to domestic mites, the skin (prick
 test) tested positive to D. pt. and D. f. showing wheal ³ 5mm, and with specific D.
 pt. IgE rate ³ Class 4+ when tested by CAP System· Patients with at least 1-year
 history of mild to moderate of severity of asthma [Steps 2 and 3 GINA (global
 initiative for asthma)]A) Mild persistent asthma (Step 2 GINA), characterized by -
 Symptoms: > 2 times per week but < 1 time per day- Exacerbations: Affect activity and
 sleep - Night-time asthma symptom: > 2 times per month- PEF (peak expiratory flow) or
 FEV1 (forced expiratory volume in the first second)- ³ 80% predicted- variability
 20-30%B) Moderate persistent asthma (Step 3 GINA), characterized by- Symptoms: Daily-
 Exacerbations: Affect activity and sleep- Night-time asthma symptom: > 1 time per
 week- PEF or FEV1 - 60 < but < 80% predicted- variability > 30%Reversibility of PEFR
 (peak expiratory flow rate) ³ 15% after inhaled b2-agonists· Patients or parents who
 have given informed consent· Patients with a FEV1 greater than 70% of predicted·
 Patients without hypersensitivity to any other airborne allergens in the standardized
 prick test panel except house dust mites

 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 ³2+ (tested by CAP)· Patients have
 been treated by subcutaneous immunotherapy with D. pt. and D. f. mites in the past 2
 years· Patients with contraindication to specific-allergen immunotherapy, such as
 immunodepression, autoimmune diseases, progressive nephropathy and malignancy of any
 system· Patients with peptic ulcers, reflux-esophagitis and other conditions such as
 ulcer/erosion proved by upper gastroenteric endoscopy or the history of upper
 gastroenteric tract bleeding· Patients with anatomical abnormality of upper
 respiratory tracts· Patients with atopic dermatitis · Patients participating in other
 clinical trials within the past 3 months prior to the study· Patients with any form
 administration of immunotherapy in previous years or ongoing· Patients with a history
 of cardiovascular, psychotic or other medical or immunologic diseases· Patients with
 other active pulmonary diseases such as tuberculosis, pneumonia or pulmonary edema·
 Patients who were treated with oral or parenteral corticosteroids (more than 15
 consecutive days), depot steroids, inhaled corticosteroids in a dosage greater than
 1000 mg/day (beclomethasone dipropionate), inhaled b2-agonists more than four times
 daily and/or oral b2-agonists or methylxanthines· Female patients who are pregnant,
 nursing or childbearing potential are not included.