A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma

Exclusion Criteria

• •Previous treatment with HDM immunotherapy for more than 1 month within the last 5 years
• •Ongoing treatment with any allergen-specific immunotherapy product
• •Reduced lung function (defined as Forced expiratory volume in 1 second (FEV1) \< 70% of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
• •Clinical history of uncontrolled asthma within 3 months prior to the screening visit
• •Having experienced a severe asthma exacerbation within 3 months prior to screening visit
• •Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization
• •Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomization
• •History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise-induced, food allergy, drugs or an idiopathic reaction)
• •History of recurrent generalized urticaria (defined as two or more episodes) during the last 2 years
• •A history of drug induced (incl. immunotherapy) facial angioedema or a family (parents and siblings) history of hereditary angioedema
• •Any chronic disease (e.g. cystic fibrosis, malignancy, malabsorption or malnutrition, renal or hepatic abnormality or any other diseases that in the opinion of the investigator would interfere with the study evaluations or the safety of the subject)
• •Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not)
• •Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit
• •Currently treated with tricyclic antidepressants; catecholamine-O-methyltransferase (COMT) inhibitors and mono amine oxidase inhibitors (MAOIs) and beta-blockers including topical administration
• •Use of medication at the screening visit which at the time of skin prick test (SPT) can interfere with the result (i.e. antihistamines)
• •Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to the screening visit
• •History of allergy, hypersensitivity or intolerance to a excipient in the investigational medicinal product (except D.Pteronyssinus and D.farinae)
• •Being immediate family of the investigator or study staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild
• •Severe mental disorders that in the opinion of the investigator would interfere with the study evaluations or the safety of the subject
• •Cardiovascular conditions in which complications are possible when using adrenaline
• •Women who are pregnant or breastfeeding