Mite Asthma Pediatric Immunotherapy Trial
Condition: Allergic Asthma Due to Dermatophagoides Farinae; Allergic Asthma Due to Dermatophagoides Pteronyssinus; Allergic Rhinitis Due to House Dust Mite
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Intervention: HDM SLIT-tablet; Placebo
Intervention description: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day); Placebo sublingual tablet, for daily administration (1 tablet per day)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 533.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Allergic asthma, allergic rhinitis, HDM, pediatric

Summary:

      The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as
      add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic
      asthma based on clinically relevant asthma worsening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Male or female of any race/ethnicity aged 5-17 years

          -  A female subject of childbearing potential must have a negative pregnancy test and be
             willing to practise appropriate contraceptive methods

          -  A clinical history of HDM allergic asthma

          -  Use of low daily dose of ICS plus LABA or medium/high daily dose of ICS with or
             without LABA for the control of asthma symptoms

          -  A clinical history of asthma exacerbations in the past two years

          -  One or more of the following within the past 4 weeks prior to randomisation:

               -  Daytime asthma symptoms more than twice/week

               -  Any nocturnal awakening due to asthma

               -  SABA rescue medication needed for treatment of asthma symptoms

               -  Any activity limitation due to asthma

          -  Lung function measured by FEV1 ≥ 70% of predicted value or according to local
             requirements

          -  Clinical history of HDM AR within the last year prior to randomisation

          -  An average TCRS>0 during the baseline period

          -  Positive specific IgE (defined as ≥class 2, ≥0.70 kU/l) against D. pteronyssinus
             and/or D. farinae at screening

          -  Positive SPT to D. pteronyssinus and/or D. farinae at screening

          -  Subject willing and able to comply with trial protocol

        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