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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Allergic Asthma Due to Dermatophagoides Farinae
  • Allergic Asthma Due to Dermatophagoides Pteronyssinus
  • Allergic Rhinitis Due to House Dust Mite
  • Asthma
  • Rhinitis
  • Rhinitis, Allergic

NCT number NCT03654976
Study type Interventional
Source ALK-Abelló A/S
Contact
Status Completed
Phase Phase 3
Start date February 22, 2018
Completion date May 31, 2022

See also
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