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

Tracking Information

First Received Date ^ICMJE

July 27, 2006

Last Updated Date

October 15, 2008

Start Date ^ICMJE

April 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Mean change from baseline in trough FEV1 after 14 day repeat doses.

Change History

Complete list of historical versions of study NCT00358488 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: GSK159797 (10, 15, and 20mcg)
Drug: salbutamol
Drug: salmeterol 50mcg
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Netherlands, Russian Federation, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00358488

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

B2E106359

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP