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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00372112
First received: September 4, 2006
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  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
Pulmonary Disease, Chronic Obstructive
 Drug: GW642444
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 2-wk 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 Subject w/COPD

Resource links provided by NLM:

U.S. FDA Resources

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) andinvestigators (during clinic assessments). [ Time Frame: 2 weeks ]

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

Enrollment: 71
Study Start Date: November 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 100 mcg GW642444H
Twice daily in the morning.
 Drug: GW642444
GW642444H
Other Name: GW642444
Active Comparator: 400 mcg GW642444H
Twice daily in the morning.
 Drug: GW642444
GW642444H
Other Name: GW642444
Active Comparator: 50 mcg salmeterol
Twice daily.
 Drug: GW642444
GW642444H
Other Name: GW642444
Placebo Comparator: placebo
Twice daily
 Drug: GW642444
GW642444H
Other Name: GW642444
Other: Placebo
Placebo administered twice daily

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
Ruse, Bulgaria, 7000
GSK Investigational Site
Sofia, Bulgaria, 1431
GSK Investigational Site
Sofia, Bulgaria, 1606
Germany
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Netherlands
GSK Investigational Site
Breda, Netherlands, 4819 EV
GSK Investigational Site
Hoorn, Netherlands, 1624 NP
New Zealand
GSK Investigational Site
Auckland, New Zealand, 1005
GSK Investigational Site
Tauranga, New Zealand
Romania
GSK Investigational Site
Bucharest, Romania, 050159
GSK Investigational Site
Iasi, Romania, 700506
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00372112     History of Changes
Other Study ID Numbers: B2C108562
Study First Received: September 4, 2006
Last Updated: October 17, 2012
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by GlaxoSmithKline:
Chronic Obstructive Pulmonary Disease (COPD)
COPD

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Salmeterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013