Mite Asthma Pediatric Immunotherapy Trial

Exclusion Criteria

• •Is sensitised and regularly exposed to animal dander, molds, and/or cockroach or other perennial allergen
• •Has experienced a life-threatening asthma attack
• •Within the last month before the randomisation visit (visit 3), has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
• •Within the last 3 months before the randomisation visit (visit 3) while on high dose ICS treatment, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
• •Any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
• •Ongoing treatment with any allergy immunotherapy product
• •Any clinically relevant condition or chronic disease incl. malignancy that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subject
• •Has a diagnosis of eosinophilic oesophagitis
• •A relevant history of systemic allergic reactions
• •Ongoing treatment with OCS
• •Treatment with restricted and prohibited concomitant medication
• •Treatment with an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
• •A history of allergy, hypersensitivity or intolerance to any of the excipients or active substance of the IMP (except D. pteronyssinus and D. farinae) or to any excipient of the rescue medication provided in this trial
• •A business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial
• •A history of alcohol or drug abuse
• •Has previously been randomised into this trial, is participating in this trial at another investigational site or is participating or planning to participate in any other clinical trial during the duration of this trial
• •Has a history or current evidence of any condition, treatment, laboratory values out of range or other circumstance that in the opinion of the investigator are clinically relevant and might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial
• •Has a condition or treatment that increase the risk of the subject developing severe adverse reactions after adrenaline/epinephrine administration
• •Is unable to or will not comply with the use of adrenaline/epinephrine auto-injectors for countries where this is a regulatory requirement