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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00347139

Purpose

In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar manner to a study that has already been completed (study number B2C101762) which examined repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data from study B2C101762 and will provide confidence (or not) that the desired bronchodilation can be achieved and maintained without undesirable side effects.

Condition	Intervention	Phase
Asthma	Drug: GW642444 (25, 100 & 400 mcg/day) Drug: salbutamol 50mcg/day	Phase II

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate 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:	Multi-Centre, Randomised, 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 (25, 100 and 400 Mcg Once Daily) of GW642444

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Mean change from baseline in trough FEV1 after repeat dosing [ Time Frame: 14 days ]

Secondary Outcome Measures:

Mean change in FEV1 [ Time Frame: after a single dose ]
Mean change in FEV1 after dosing [ Time Frame: 7 days ]
Weighted Mean FEV1 0-2, 0-4 and 0-24h [ Time Frame: on Day 1, Day 7, Day 14 ]
AM PEFR AM FEV1 [ Time Frame: over Days 2-15 ]
PM PEFR PM FEV1 [ Time Frame: over Days 1-14 ]

Enrollment:	56
Study Start Date:	May 2006
Study Completion Date:	January 2007

Eligibility

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

Criteria

Inclusion criteria:

Subjects with a documented history of persistent asthma.
Current non-smokers.
Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values.
Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent.

Exclusion criteria:

Subjects with significant past or present disease which which may affect their safety.
Upper or lower respiratory tract infection within 4 weeks of screening.
History of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study.
Patients taking doses of inhaled corticosteroid >500mcg/day and patients who have changed therapy within 8 weeks of the study.
Patients weighing less than 50kg.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347139

Locations

Germany, Hessen
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65187
Germany, Schleswig-Holstein
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
New Zealand
GSK Investigational Site
Wellington 6004, New Zealand, 6004
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 105 077
Sweden
GSK Investigational Site
GÖTEBORG, Sweden, SE-413 45
United Kingdom
GSK Investigational Site
London, United Kingdom, SE5 9RJ

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	B2C106093
Study First Received:	June 29, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00347139
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; New Zealand: Health Research Council; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

GW642444
Asthmatic patients
Efficacy
Safety

Tolerability
Pharmacodynamics
Pharmacokinetics

Study placed in the following topic categories:

Naphazoline
Oxymetazoline
Guaifenesin
Phenylephrine

Albuterol
Asthma
Phenylpropanolamine

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Adrenergic Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Reproductive Control Agents

Pharmacologic Actions
Adrenergic Agonists
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009