Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00354042

Purpose

This study is designed to look at the safety aspects and effects of repeat inhaled doses of GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive Pulmonary Disease(COPD).

Condition	Intervention	Phase
Asthma	Drug: GW597901X	Phase I

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Safety Study
Official Title:	A Randomised, Double-Blind, Placebo-Controlled, Dose Ascending, 4 Period Crossover Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Inhaled Doses of GW597901X in Asthmatic Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects.

Secondary Outcome Measures:

Effects on the lungs at 12 and 24 hours Effects on the heart, blood pressure and heart rate at 8 hours Effects on blood tests over 4 hours and 8 hours Reduction of rescue medication.

Estimated Enrollment:	24
Study Start Date:	August 2004

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Subjects with mild to moderate stable asthma but no other lung problems.
Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
Non-Smokers.
Subjects who show a measurable improvement in the function of their lungs after a single dose of salbutamol.

Exclusion criteria:

Any significant illness.
Subjects with heart problems.
Subjects who have a cold or chest infection 2-4 weeks prior to the study or have life-threatening asthma.
Subjects who take medication for their asthma, or other conditions, not compatible with this study.
Subjects who are over sensitive to salbutamol or to ipratropium.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354042

Locations

Germany, Brandenburg
GSK Investigational Site
Hennigsdorf, Brandenburg, Germany, 16761

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, MSc, FPPM

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	B2A100517
Study First Received:	July 18, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00354042
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

GW597901X
Asthma
Crossover

dose ascending
repeat dose
inhaled

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009