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01
Overview
Phase 2, randomised, open-label trial of GSK256066 in seasonal allergic rhinitis (SAR) (5 arms), sponsored by GSK. Primary endpoint: Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene Expression at Day 1. Started Mar 2007; status: completed.
02
Design
5 arms- Study design
- RandomizedOpen-label
GSK256066 200mcg
Single intranasal dose of GSK256066 200mcg
GSK256066 50mcg
Single intranasal dose of GSK256066 50mcg
GSK256066 Low Dose 1
Single intranasal dose of GSK256066 (lower dose)
GSK256066 Low Dose 2
Single intranasal dose of GSK256066 (lower dose)
Placebo
Single intranasal dose of Placebo
03
Who it enrols
Healthy subjects with a history of seasonal allergic rhinitis (hayfever) and positive skin prick/RAST tests for grass pollen.
04
Endpoints
Primary
Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene Expression
Secondary
Mean Forced Expiratory Volume in One Second
Mean Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Mean Heart Rate
Change From Baseline in Electrocardiogram (ECG) Values
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Area Under the Plasma Drug Concentration Versus Time Curve (AUC0-last) of GSK256066
Maximum Observed Plasma Drug Concentration (Cmax) of GSK256066
Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK256066
05
Results
Primary endpoints met
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