A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Children and Adolescents (5-17 Years) With HDM Allergic Asthma
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Allergic Asthma Due to Dermatophagoides Farinae
- Sponsor
- ALK-Abelló A/S
- Enrollment
- 533
- Locations
- 64
- Primary Endpoint
- Annualized Rate of Clinically Relevant Asthma Exacerbations
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
The trial aims to demonstrate efficacy of the HDM SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with HDM allergic asthma based on clinically relevant asthma exacerbations. Additionally, the trial will investigate if the treatment has an effect on asthma symptoms including nightly awakenings due to asthma, asthma medication use, asthma control, lung function, allergic rhinitis and allergic rhinoconjunctivitis. Finally, quality of life (QoL) for subjects and caregivers will be measured. The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 2 years. Subjects will receive a written asthma action plan.
Investigators
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
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
Outcomes
Primary Outcomes
Annualized Rate of Clinically Relevant Asthma Exacerbations
Time Frame: Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period)
The primary endpoint of the trial was the annualized rate of clinically relevant asthma exacerbations calculated as the number of exacerbations per year per participant during the efficacy evaluation period of 20 months. A clinically relevant asthma exacerbation had to be medically confirmed and was defined as asthma worsening leading to at least 1 of the following criteria: * Doubling of ICS dose compared to background treatment * Systemic corticosteroids for treatment of asthma symptoms for at least 3 days * Emergency room visit due to asthma, requiring systemic corticosteroids * Hospitalization for more than 12 hours due to asthma, requiring treatment with systemic corticosteroids The outcome measure (by treatment group) is an adjusted annualized rate of clinically relevant asthma exacerbations.
Secondary Outcomes
- Global Evaluation of Allergic Asthma as Having an Improved Outcome(Assessment done at the end of trial visit (after 24-30 months of treatment))
- Proportion of Days With Nocturnal Awakenings Due to Asthma Requiring SABA Rescue Medication(Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period))
- Proportions of Days With SABA Use(Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period))
- Global Evaluation of Allergic Rhinitis as Having an Improved Outcome(Assessment done at the end of trial visit (after 24-30 months of treatment))
- Percentage Predicted FEV1(Efficacy assessment period was 20 months (following a 4-10 months treatment initiation and maintenance period))