Ignite Creation Date:
2024-05-06 @ 1:59 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04176185
Status:
TERMINATED
Last Update Posted:
2022-06-30
First Post:
2019-10-25
Brief Title:
A Research Study in Chinese People With Allergy to House Dust Mites Using an Environmental Exposure Chamber
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 Adult Chinese Subjects With HDM Allergic RhinitisRhinoconjunctivitis Using an Environmental Exposure Chamber
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUEST
Brief Summary:
This trial evaluates the efficacy and safety of HDM SLIT-tablet in treatment of HDM AR The efficacy is evaluated using an environmental exposure chamber EEC Subjects will be randomised to receive treatment with HDM SLIT-tablet and placebo 11
Detailed Description:
This trial is a 24 weeks randomised parallel-group double-blind placebo-controlled phase III trial Approximately 202 subjects will be randomised 11 to receive treatment with HDM SLIT-tablet or placebo The trial will be conducted in China with subjects recruited and treated in China Two EEC assessments baseline and end of treatment will take place at a validated EEC facility in Austria
The primary objective is to demonstrate the efficacy of the HDM SLIT-tablet 12 SQ-HDM once daily compared to placebo in the treatment of HDM AR nasal symptom determined during the EEC session at week 24
The primary objective is to demonstrate the efficacy of the HDM SLIT-tablet 12 SQ-HDM once daily compared to placebo in the treatment of HDM AR nasal symptom determined during the EEC session at week 24
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None