None listed
Conditions
Interventions
Each subject will be provided with 12 SQ HDM-
SLIT tablet (Acarizax®) at Visit 1 and every visit thereafter. Acarizax® will be prescribed according to Thai-
FDA approved leaflet. The daily dose of Acarizax® is 1 tablet per day. The tablet is placed under the tongue,
where it will disperse.
Experimental Biological/Vaccine
12 SQ HDM-
SLIT tablet (Acarizax®)
Sponsors
Abbott Laboratories Limited
ALK-Abello AS
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female with age of 18-65 years for allergic rhinitis with or without asthma 2. Clinical history and a positive test of house dust mite sensitization (skin prick test and specific IgE test) with confirmed diagnosis of either one of the following: 3. Persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication 4. House dust mite induced asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis 5. Positive skin prick test (SPT) response to Dermatophagoides pteronyssinus (Dp) or Dermatophagoides farinae (Df) (wheal diameter >5 mm or wheal diameter >3 mm larger than negative control) by using standardized solution (Alk-Abello AS) Or Positive specific IgE against Dp or Df (> IgE Class 2; > 0.70 kU/L). 6. Positive SPT to other allergens should be weak with wheal diameter <5 mm. 7. FEV1 > 70% of predicted value (for AA patients) after adequate pharmacologic treatment.
Exclusion criteria
Exclusion criteria: 1. A relevant clinical history of perennial allergic rhinitis with or without asthma caused by other allergens. 2. Clinical history of uncontrolled asthma within 3 months prior to screening. 3. Previous treatment with immunotherapy with HDM allergen for more than 1 month within the last 5 years. 4. Inflammatory conditions in the oral cavity or severe oral mycosis at visit 1. 5. Symptoms of or treatment for upper respiratory tract infection 6. Structural lung disease (e.g. chronic obstructive pulmonary disease (COPD), bronchitis, old pulmonary tuberculosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HDM-specific IgG4 response to D.farinae and D.pteronyssinus month 4 blood test | — |
Secondary
| Measure | Time frame |
|---|---|
| Specific IgE against D.farinae and D.pteronyssinus month 4 blood test,Total nasal symptom score (TNSS) month 4 diary record,Total combined rhinitis scores (TCRS) month 4 diary record,Level of nasal cytokines month 4 nasal secretion analysis,Mean wheal diameter of D.farinae and D.pteronyssinus month 4 skin prick test,improvement in asthma month 4 asthma control test,Correlation between change in HDM-specific IgG4 and symptom improvement month 4 correlation analysis,Correlation between change in relevant cytokine level in nasal secretion and symptom improvement month 4 correlation analysis,Safety and tolerability month 1, 2 and 4 diary record, physical examination | — |
Countries
Thailand
Contacts
Public ContactAssoc.Prof. Pongsakorn Tantilipikorn
Mahidol University
Outcome results
None listed