Study to Assess GW642444 in Asthma Patients

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: GW642444M; Drug: GW642444H; Other: placebo

• Registration Number: NCT00381667
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a study of GW642444M, a long-acting beta 2 specific agonist. This study will examine GW642444M via the inhaled route and will assess the efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses (25, 100 and 400 µg) of GW642444M in persistent asthmatics. This study will be a single-centre, placebo-controlled, dose-ascending, five-way crossover in 30 asthmatic patients.

Key assessments: efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics will be assessed by measurement of FEV1, blood pressure, pulse rate, 12-lead ECGs, clinical laboratory safety tests, collection of adverse events and blood samples.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-26
• Study First Posted: 2006-09-28
• 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: All
• Target Recruitment: 14

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
GW642444M 12.5	GW642444M	-
GW642444M 100mcg	GW642444M	-
GW642444M 400mcg	GW642444M	-
GW642444H 100mcg	GW642444H	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Adverse events	throughout study
Mean change from baseline FEV1 24 hours after dosing.	Day 1, on 5 separate occasions
Laboratory safety tests	throughout study
Holter monitoring	throughout study
Vital signs and 12-lead ECG)	throughout study
Supine systolic and diastolic blood pressure and supine heart rate	Day 1 on 5 separate occasions
QTc(B)and QTc(F)	Day 1 on 5 separate occasions

Secondary Outcome Measures

Name	Time	Method
Glucose Max increase from baseline	Day 1 on 5 separate occasions
Mean change from baseline(0-4h)potassium.	Day 1 on 5 separate occasions
Potassium Max decrease from baseline	Day 1 on 5 separate occasions
Weighted mean change from baseline (0-4h)glucose	Day 1 on 5 separate occasions
Derived PK parameters: Cmax, Tmax, AUC(0-t), AUC(0-inf),PEFR	Day 1 on 5 separate occasions

Trial Locations

Locations (1)

GSK Investigational Site; 🇳🇿 Wellington, New Zealand