NCT00377728

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)

Completed Phase 2 Last updated 14 April 2015

What this trial tests

Phase 2 trial testing GSK256066 in Rhinitis, Allergic, Seasonal in 44 participants. Completed in 1 May 2006.

Timeline

1 March 2006

Primary endpoint
1 May 2006

1 May 2006

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	44
Start date	1 March 2006
Primary completion	1 May 2006
Estimated completion	1 May 2006
Sites	1 location across Austria

Drugs / interventions tested

• GSK256066 — full drug profile →

Conditions studied

• Rhinitis, Allergic, Seasonal — all drugs for Rhinitis, Allergic, Seasonal →
• Seasonal Allergic Rhinitis — all drugs for Seasonal Allergic Rhinitis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 50, any sex, with Rhinitis, Allergic, Seasonal or Seasonal Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.