Ignite Creation Date:
2024-05-06 @ 1:09 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01740284
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
2012-11-14
Brief Title:
A Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine
Sponsor:
ALK-Abelló AS
Organization:
ALK-Abelló AS
Study Overview
Official Title:
A Phase III Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
Status:
COMPLETED
Status Verified Date:
2013-02
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:
GT-19
Brief Summary:
Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment
The majority are local allergic reactions within the mouth andor throat and most of these reactions are mild or moderate It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment So this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions
The majority are local allergic reactions within the mouth andor throat and most of these reactions are mild or moderate It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment So this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions
Detailed Description:
Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment The adverse events are considered consistent with the introduction of allergens in sensitised subjects The majority are local allergic reactions within the mouth andor throat Most of these reactions are mild or moderate in intensity have an onset almost immediately after taking a tablet and last from minutes to hours after intake Appearance of adverse events in relation to tablet intake tends to subside spontaneously within 1 to 7 days Thus initiation of treatment with Grazax may be associated with discomfort It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment Therefore the rationale for this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions
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