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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
GSK Investigational Site
Vienna, Austria
Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)
Time frame: 1-4h post-dose period spent in the Vienna Challenge Chamber on Day 7
Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)
Time frame: 1-4h post morning dose period spent in the Vienna Challenge Chamber on Day 2.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.