Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03654976
Status:
COMPLETED
Last Update Posted:
2023-10-19
First Post:
2018-08-24
Brief Title:
Mite Asthma Pediatric Immunotherapy Trial
Sponsor:
ALK-Abelló AS
Organization:
ALK-Abelló AS
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAPIT
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-004363-39 | EUDRACT_NUMBER | None | None |