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.
Who can participate
Age range5 Years – 17 Years
SexALL
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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 clinica…
What they're measuring
1
Annualized Rate of Clinically Relevant Asthma Exacerbations
Timeframe: Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period)