Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents

Inclusion criteria

• Written informed consent from patient and parent(s)/legal representative.
• Male or female patient from 12 to 17 years.
• Diagnosed rhinitis with medical history consistent with HDM-induced allergic rhinitis for at least 1 year before visit 1
• Positive Skin Prick Test to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kUnit/L.
• Concommittant controlled asthma allowed up to GINA 1 or 2 treatment step
• Spirometry with best FEV1 > 80% of predicted FEV1.

Exclusion criteria

• Patient with a nasal or oral disease that could interfere with the safety assessments
• Patient has undergone recent nasal surgery
• Patient with asthma receiving therapy consistent with GINA (Global INitiative for Asthama) treatment step 3, 4, or 5.
• Patient with partially controlled or uncontrolled asthma
• Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study.
• Female patient pregnant or breast-feeding/lactating.
• Female patient of childbearing potential planning a pregnancy during this trial or not using a medically accepted contraceptive method.
• Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
• Patient who received allergy specific immunotherapy for house dust mites for more than 1 month in the 5 years before screening or who is currently receiving immunotherapy with any allergen.
• patient with a history of anaphylaxis
• patient having participated in any clinical study within the 12 weeks before visit 1