Trial With Rhinitic Patients Taking GSK256066 Versus Placebo In A Pollen Challenge Chamber
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. Opportunity to assess the efficacy of compounds versus placebo at maximal and trough plasma concentrations.
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.
|Rhinitis, Allergic, Seasonal Seasonal Allergic Rhinitis||Drug: GSK256066||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A 14 Day, Randomised, Double Blinded, Placebo-controlled 2-way Crossover Trial of Repeat Doses of Intranasal GSK256066 and Placebo in an Environmental Exposition Unit (Vienna Challenge Chamber) in Subjects With Seasonal Allergic Rhinitis (SAR)|
- Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction) 0-6h post-dose period spent in the Vienna Challenge Chamber on Day 8 or 14
- Weighted mean nasal, eye and global symptom score and weighted mean nasal airflow resistance and secretion weight over 0-6 hours and 22-26h post dose on Day 8 (period 2 only) or Day 14 (period 1 only). FEV1, ECGs, AEs, and lab safety parameters
|Study Start Date:||March 2006|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377728
|GSK Investigational Site|
|Vienna, Austria, A-1150|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|