Ignite Creation Date:
2024-05-06 @ 7:44 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02596321
Status:
COMPLETED
Last Update Posted:
2018-03-01
First Post:
2015-11-02
Brief Title:
A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis andor Atopic Asthma
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With Allergic Rhinitis andor Atopic Asthma Induced by House Dust Mites
Status:
COMPLETED
Status Verified Date:
2018-02
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:
None
Brief Summary:
To demonstrate superiority of ALK HDM tablets versus placebo in immune response measured as change of Dfarinae specific immunoglobulin G4 IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days
Detailed Description:
To demonstrate superiority of ALK HDM tablets versus placebo in the immune response measured as change of D Farinae specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days
To evaluate the immune response measured as change of D pteronyssinus D farinae specific immunoglobulin E IgE and D pteronyssinus specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days compared to placebo
To evaluate in patients with HDM-allergic respiratory disease the safety and tolerability of 60-day treatment with ALK HDM tablets compared to placebo
To evaluate the immune response measured as change of D pteronyssinus D farinae specific immunoglobulin E IgE and D pteronyssinus specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days compared to placebo
To evaluate in patients with HDM-allergic respiratory disease the safety and tolerability of 60-day treatment with ALK HDM tablets compared to placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None