Investigation Of A New Medication (GW642444) In Asthmatic Patients

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: GW642444; Drug: salmeterol 50mcg; Drug: Placebo

• Registration Number: NCT00354874
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects.

Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2006-07-18
• Study First Submitted QC: 2006-07-18
• Study First Posted: 2006-07-20
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GW642444 100mcg	GW642444	-
GW642444 200mcg	GW642444	-
GW642444 50mcg	GW642444	-
salmeterol 50mcg	salmeterol 50mcg	-
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
FEV1 at 24 hours after a single dose.	24 hours on 4 separate occasions

Secondary Outcome Measures

Name	Time	Method
FEV1 - Days 1 and 7	Days 1 and 7 on 4 separate occasions
Mean morning/evening PEFR	Days 3-8 on 4 separate occasions
BP, HR & QTc on Days 1 and 7	Days 1 and 7 on 4 separate occasions
Potassium and glucose on Days 1 and 7	Days 1 and 7 on 4 separate occasions
safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG	throughout study
PK parameters	Days 1, 4 and 7 on 4 separate occasions

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇪 Göteborg, Sweden