Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients

This study has been completed.

First Received: July 27, 2006 Last Updated: October 15, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00358488

Purpose

This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.

Condition	Intervention	Phase
Asthma	Drug: GSK159797 (10, 15, and 20mcg) Drug: salbutamol Drug: salmeterol 50mcg Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Multi-Enter, Randomized, 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 (10, 15, and 20 Mcg) of GSK159797

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Salmeterol Salmeterol xinafoate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Mean change from baseline in trough FEV1 [ Time Frame: after 14 day repeat doses ]

Secondary Outcome Measures:

Mean change from baseline in trough FEV1 [ Time Frame: after a single dose ]
Mean change from baseline in trough FEV1 [ Time Frame: after 7 days repeat dosing ]
Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours [ Time Frame: Day 1 and Day 14 ]

Enrollment:	54
Study Start Date:	April 2006
Study Completion Date:	January 2007

Eligibility

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

Criteria

Inclusion criteria:

Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
Female subjects only using acceptable birth control method
Non-smokers
FEV1 between 60 and 90% predicted
Increase in FEV1 12% or greater and 300mL and greater after salbutamol use

Exclusion criteria:

Past or present disease conditions
Normal screening Holter ECG
Respiratory tract infection within 4 weeks of screening
History of life threatening asthma
Previous use of COA

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358488

Locations

Germany
GSK Investigational Site
Berlin, Germany, 14057
Germany, Hessen
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65187
Netherlands
GSK Investigational Site
UTRECHT, Netherlands, 3584 CJ
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 115446
Sweden
GSK Investigational Site
LUND, Sweden, SE-221 85
United Kingdom
GSK Investigational Site
Manchester, United Kingdom, M23 9LT

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	B2E106359
Study First Received:	July 27, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00358488 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

GSK159797
Asthmatic patients
Efficacy
Safety

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on November 27, 2009