Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04145219
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2019-10-11
Brief Title:
House Dust Mite Allergy Trial In Children
Sponsor:
ALK-Abelló AS
Organization:
ALK-Abelló AS
Study Overview
Official Title:
A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite HDM SLIT-tablet in Children 5-11 Years of Age With HDM Allergic RhinitisRhinoconjunctivitis With or Without Asthma
Status:
COMPLETED
Status Verified Date:
2024-06
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:
MATIC
Brief Summary:
A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites MATIC
Detailed Description:
The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet compared to placebo in children 5-11 years of age with House Dust Mite allergic rhinitis based on the total combined rhinitis symptoms and medication score during the last 8 weeks of treatment
In addition the trial will evaluate safety and tolerability of the treatment and assess whether treatment has an impact on asthma symptoms and medication use immunological parameters and rhinoconjunctivitis quality of life QoL
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 1 year
In addition the trial will evaluate safety and tolerability of the treatment and assess whether treatment has an impact on asthma symptoms and medication use immunological parameters and rhinoconjunctivitis quality of life QoL
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 1 year
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