ALK-Abelló A/S
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.
Allergic Asthma Due to Dermatophagoides Flour
Allergic Asthma Due to Dermatophagoides Pteronyssinus
Allergic Rhinitis Due to House Dust Mite
HDM SLIT-tablet
Placebo
PHASE3
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.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 533 participants |
Masking : | QUADRUPLE |
Masking Description : | Double-blind |
Primary Purpose : | TREATMENT |
Official Title : | 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 |
Actual Study Start Date : | 2018-02-22 |
Estimated Primary Completion Date : | 2022-05-18 |
Estimated Study Completion Date : | 2022-05-31 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 5 Years to 17 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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