Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: GSK159797 (10, 15, and 20mcg); Drug: salmeterol 50mcg; Drug: placebo; Drug: salbutamol

• Registration Number: NCT00358488
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-07-27
• Study First Submitted QC: 2006-07-27
• Study First Posted: 2006-07-31
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GSK159797 (10, 15, and 20mcg)	GSK159797 (10, 15, and 20mcg)	GSK159797 (10, 15, and 20mcg)
salmeterol 50mcg	salmeterol 50mcg	salmeterol 50mcg
placebo	placebo	placebo
salbutamol	salbutamol	salbutamol

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in trough FEV1	after 14 day repeat doses

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Manchester, United Kingdom