Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-13 @ 9:56 AM
Study NCT ID:
NCT00619827
Status:
COMPLETED
Last Update Posted:
2016-05-23
First Post:
2008-02-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract
Sponsor:
Stallergenes Greer
Organization:
Study Overview
Official Title:
A Randomised, Double-blind, in Parallel Groups Placebo-controlled, Mono-centre, Phase I Study to Assess After Allergen Challenge in an Allergen Exposition Chamber the Effect and Its Time Course of Sublingual Immunotherapy (SLIT) Administered as 300IR Allergen-based Tablets Once Daily to Adults Suffering From Grass Pollen Rhinoconjunctivitis
Status:
COMPLETED
Status Verified Date:
2016-04
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:
The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.
Detailed Description:
The purpose of this study is to determine whether SLIT tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT tablets on allergic rhinitis symptoms.
Study Oversight
Has Oversight DMC:
False
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?: