A Multi-enter, Randomized, Double-blind, Placebo-controlled, Four-way Incomplete Block Crossover Study to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (10, 15, and 20 mcg) of GSK159797

GlaxoSmithKline1 site in 1 country54 target enrollmentApril 2006

ConditionsPulmonary Disease, Chronic Obstructive

InterventionsGSK159797 (10, 15, and 20mcg)salbutamol salmeterol 50mcg placebo

DrugsGSK159797 (10, 15, and 20mcg)salbutamol salmeterol 50mcg placebo

Overview

Phase: Phase 2
Intervention: GSK159797 (10, 15, and 20mcg)
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Enrollment: 54
Locations: 1
Primary Endpoint: Mean change from baseline in trough FEV1
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

January 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

GSK159797 (10, 15, and 20mcg)

Intervention: GSK159797 (10, 15, and 20mcg)

salbutamol

Intervention: salbutamol

salmeterol 50mcg

Intervention: salmeterol 50mcg

placebo

Intervention: placebo

Outcomes

Primary Outcomes

Mean change from baseline in trough FEV1

Time Frame: after 14 day repeat doses

Secondary Outcomes

Mean change from baseline in trough FEV1(after 7 days repeat dosing)
Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours(Day 1 and Day 14)