Trials / Completed
CompletedNCT03654976
Mite Asthma Pediatric Immunotherapy Trial
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 533 (actual)
- Sponsor
- ALK-Abelló A/S · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Allergic Asthma Due to Dermatophagoides Farinae
- Allergic Asthma Due to Dermatophagoides Pteronyssinus
- Allergic Rhinitis Due to House Dust Mite
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HDM SLIT-tablet | Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day) |
| OTHER | Placebo | Placebo sublingual tablet, for daily administration (1 tablet per day) |
Timeline
- Start date
- 2018-02-22
- Primary completion
- 2022-05-18
- Completion
- 2022-05-31
- First posted
- 2018-08-31
- Last updated
- 2023-10-19
- Results posted
- 2023-10-19
Locations
64 sites across 9 countries: United States, Bulgaria, France, Germany, Hungary, Poland, Russia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03654976. Inclusion in this directory is not an endorsement.