Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00749411
First received: September 8, 2008
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Placebo
Drug: GSK233705/GW642444
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Placebo-controlled, Parallel-group, 4-week Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Inhaled Doses of the Combination of GSK233705 and GW642444 Administered Once-daily in Subjects With COPD

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Weight mean heart rate 0-4 hours post dose [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: 28 days ]
  • systolic and diastolic blood pressure [ Time Frame: 28 days ]
  • QTc measured by ECG [ Time Frame: 28 days ]
  • plasma glucose and serum potassium [ Time Frame: 28 days ]
  • Holter monitoring [ Time Frame: 28 days ]
  • Forced expiratory volume in one second (FEV1) [ Time Frame: 28 days ]
  • Pharmacodynamic assessments [ Time Frame: 28 days ]

Enrollment: 61
Study Start Date: November 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: GSK233705/GW642444
The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler.
Placebo Comparator: Arm 2 Drug: Placebo
matching placebo

  Eligibility

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

Inclusion Criteria:

  • male and females 40 to 80 years of age (inclusive)
  • COPD diagnosis
  • Current or previous smokers with a cigarette smoking history of at least 10 pack-
  • Post-albuterol FEV1/FVC of 0.70 or less
  • Post-albuterol FEV1 of 35% to 80% (inclusive)

Exclusion Criteria:

  • Pregnant or lactating females
  • current diagnosis of asthma
  • respiratory disorders other than COPD
  • clinically significant cardiovascular, neurological, psychiatric, renal, immunological, endocrine, or hematological abnormalities that are uncontrolled
  • clinically significant sleep apnea
  • previous lung resection surgery
  • clinically significant abnormalities confirmed by chest x-ray that are not related to COPD
  • hospitalization for COPD within 3 months of screening
  • use of antibiotics for lower respiratory tract infection within 6 months of screening
  • abnormal and clinically significant 12-lead ECG findings
  • current malignancy in remission for less that 5 years
  • medical conditions that would contraindicate the use of anticholinergics
  • positive hepatitis B or C test
  • history of alcohol or drug abuse
  • unable to withhold albuterol for 6 or more hours
  • use of long term oxygen therapy
  • conditions that would limit the validity of informed consent
  • use of GW642444 or GSK233705 in previous studies
  • use of an investigation drug with 30 days of screening
  • use of inhaled corticosteroids (ICS) at a dose greater than 1000mcg of fluticasone propionate or equivalent
  • hypersensitivity to beta-agonists
  • concurrent use of long-acting beta-agonists (LABA) or long-acting muscaring antagonists, LABA/ICS combination products, cytochrome p450 inhibitors, oral or depot corticosteroids, theophyllines, oral beta agonists, oral leukotrine modulators, inhaled short acting anticholinergics.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749411

Locations
United States, Alabama
GSK Investigational Site
Mobile, Alabama, United States, 36608
United States, Colorado
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Maine
GSK Investigational Site
Biddeford, Maine, United States, 04005
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, New Jersey
GSK Investigational Site
Summit, New Jersey, United States, 07091
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
United States, South Carolina
GSK Investigational Site
Greenville, South Carolina, United States, 29615
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Washington
GSK Investigational Site
Spokane, Washington, United States, 99204
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00749411     History of Changes
Obsolete Identifiers: NCT00843206
Other Study ID Numbers: DB1111581
Study First Received: September 8, 2008
Last Updated: October 17, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
COPD
long-acting beta agonist
Emphysema
Chronic Bronchitis
Chronic Obstructive Pulmonary Disease (COPD)
bronchodilator
long acting muscarinic antagonist

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014