A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00372112

Purpose

The compound GW642444 has previously been found to be well tolerated with no significant side effects in subjects with asthma and healthy volunteers.

This study will assess the safety and tolerability of GW642444 in subjects with COPD in order to obtain information to support dosing in a broader population of subjects with COPD

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: GW642444	Phase II

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Incidence of Adverse Events (AEs) reported prior to, throughout and after the 2- week treatment period as recorded by subjects on daily record cards (DRCs) and investigators (during clinic assessments).

Secondary Outcome Measures:

Heart Rate and Blood Pressure QTc(F)and QTc(B)values from 12-lead ECGs. FEV1 (forced expiratory volume in 1 second). Peak Flow and use of rescue medication

Estimated Enrollment:	80
Study Start Date:	November 2006

Detailed Description:

A multicentre, randomised, placebo-controlled, double-blind, 4-arm parallel-group, 2-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GW642444H (100 administered once daily in the morning via DISKUS™ dry-powder inhaler) compared with SEREVENT (salmeterol) (50mcg administered twice daily via DISKUS dry-powder inhaler) and placebo in subjects with moderate COPD.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

females must be of non-childbearing potential
moderately severe COPD

Exclusion criteria:

Subjects with a main diagnosis of asthma
subjects with poorly controlled COPD
subjects with significant heart, renal, endocrine, psychiatric, immunological or neurological disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372112

Locations

Australia, New South Wales
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Australia, Western Australia
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Bulgaria
GSK Investigational Site
Sofia, Bulgaria, 1606
GSK Investigational Site
Ruse, Bulgaria, 7000
GSK Investigational Site
Sofia, Bulgaria, 1431
Germany, Baden-Wuerttemberg
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Germany, Niedersachsen
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Germany, Schleswig-Holstein
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Netherlands
GSK Investigational Site
HOORN, Netherlands, 1624 NP
GSK Investigational Site
Hoofddorp, Netherlands, 2130 AT
GSK Investigational Site
BREDA, Netherlands, 4819 EV
New Zealand
GSK Investigational Site
Auckland, New Zealand, 1005
GSK Investigational Site
Tauranga, New Zealand
Romania
GSK Investigational Site
Iasi, Romania, 700506
GSK Investigational Site
Bucharest, Romania

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:	B2C108562
Study First Received:	September 4, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00372112 History of Changes
Health Authority:	New Zealand: Health and Disability Ethics Committees

Keywords provided by GlaxoSmithKline:

COPD

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 06, 2009