Investigation Of A New Medication (GW642444) In Asthmatic Patients - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00354874

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: GW642444	Phase II

MedlinePlus related topics: Asthma

Drug Information available for: Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Ascending, Four Way Crossover Study to Examine Efficacy (FEV1), Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Doses of GW642444

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

FEV1 at 24 hours after a single dose.

Secondary Outcome Measures:

FEV1 - Days 1 and 7
Mean morning/evening PEFR
BP, HR & QTc on Days 1 and 7
Potassium and glucose on Days 1 and 7
safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG
PK parameters

Enrollment:	28
Study Start Date:	January 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
Non-smokers for at least 6 months.
Stable asthma.

Exclusion criteria:

Abnormal findings on heart monitoring assessment.
Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study.
Currently taking doses of fluticasone propionate over 500mcg/day.
Unstable asthma medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354874

Locations

Germany, Hessen
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65187
Germany, Schleswig-Holstein
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Sweden
GSK Investigational Site
GÖTEBORG, Sweden, SE-413 45

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	B2C101762
Study First Received:	July 18, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00354874
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:

GW642444 asthmatic subjects safety tolerability PD and PK

Study placed in the following topic categories:

Naphazoline
Oxymetazoline
Guaifenesin

Phenylephrine
Asthma
Phenylpropanolamine

ClinicalTrials.gov processed this record on January 14, 2009