A Randomised, Double-blind, Placebo-controlled, Parallel Group, Repeat Dose Study to Assess the Effect of SB-480848 on Overall Asthma Control in Adult Subjects With Persistent Asthma Controlled on Stable, Low-dose, Inhaled Corticosteroids

GlaxoSmithKline1 site in 1 country67 target enrollmentAugust 2006

Overview

The purpose of this study is to compare the effects of SB-480848 with placebo in subjects with asthma.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

October 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Male and female subjects who have documented persistent asthma for at least 3 months
•Subjects must have been on a stable, low-dose ICS for a minimum of 4 weeks prior to the screening visit.
•Aged 18-65 years, at screening
•FEV1 greater than or equal to 70% predicted (ECCS, 1993)
•Subjects must show an increase in FEV1 greater than or equal to 12% (and an absolute change \>200mL) within 30 minutes following inhalation of 4 puffs of albuterol/salbutamol or 1 nebulized treatment of 2.5mg or have historical, documented evidence of reversibility, within 12 months prior to screening
•Subjects must be willing to replace their inhaled, short-acting β2-agonist with study provided albuterol/salbutamol
•Patient must be capable of giving informed consent and comply with the study requirements and timetable.
•Inclusion Criteria following run in period (Prior to randomisation) Subjects will be screened based on the inclusion and exclusion criteria noted above.
•During the run-in period \[Day -14 to Day 1\], subjects will be asked to maintain a diary card and document the number of puffs of rescue inhaled, short-acting β2-agonists taken, asthma-related symptoms and night time awakenings as well as morning and evening PEF measurements.
•On the morning of Day 0, subjects will be eligible for randomisation into the study if all of the following criteria are met:

FEV1

Time Frame: 6 hours post-dose, Days 7, 14 and 21

Methacholine challenge Amounts of certain chemicals/proteins in blood Amount of drug in the blood(before dosing and after 21 days of dosing)
Measurements of FEV1 following single doses of SB-480848 and placebo.
Measurements of PC20 on Day 21 +24hrs after dosing with SB-480848 and placebo.(Day 21 +24hrs after dosing)
Blood drug levels of SB-553253 [metabolite of SB-480848] may be assessed, as appropriate.
Urinary leukotriene concentrations after 21 days of dosing with SB-480848 and Placebo.(after 21 days)
Blood levels of LpPLA2 and CD62 concentrations over 21-day dosing period with SB-480848 and placebo(over 21-day dosing period)
Measurements of FEF25-75 and peak expiratory flow following single and repeat oral doses of SB-480848.
Assessment of vitals, ECGs, safety labs and number of puffs of rescue inhaled, short-acting β2-agonists taken, asthma-related symptoms and night time awakenings, number of subjects withdrawn due to worsening of asthma on SB- 480848 and placebo.