Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430157
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2007-01-30
Brief Title:
Trial With Allergic Rhinitis Patients Taking GSK256066 Versus Placebo In A Pollen Challenge Chamber
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An 8 Day Randomised Double Blinded Placebo-controlled 2-way Crossover Trial of Repeat Doses of Intranasal GSK256066 and Placebo in the Vienna Challenge Chamber in Subjects With Seasonal Allergic Rhinitis SAR
Status:
COMPLETED
Status Verified Date:
2011-02
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:
This study is in patients with seasonal allergic rhinitis SAR and will compare the effect versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber GSK256066 is a potent and highly selective phosphodiesterase-4 PDE4 inhibitor currently in development by GSK for the treatment of allergic rhinitis asthma and COPD
Subjects will be selected on the basis that they display a defined moderate response to the pre-determined dose used
This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo
12-lead ECG vital signs and adverse event enquiries will be made throughout the study Nasal examination symptom scores TNSS nasal lavage nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study
Subjects will be selected on the basis that they display a defined moderate response to the pre-determined dose used
This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo
12-lead ECG vital signs and adverse event enquiries will be made throughout the study Nasal examination symptom scores TNSS nasal lavage nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study
Detailed Description:
None
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