28-day Repeat Dose Study of GSK573719

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01030965
First received: December 10, 2009
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: GSK573719 125mcg
Drug: GSK573719 250mcg
Drug: GSK573719 500mcg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of GSK573719 Delivered Once-daily Over 28 Days in Subjects With COPD

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Pre-dose (trough) forced expiratory volume in one second (FEV1) [ Time Frame: 29 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weighted mean FEV1 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Serial FEV1 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 287
Study Start Date: December 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK573719 125mcg
125mcg once-daily via novel dry powder inhaler
Drug: GSK573719 125mcg
125mcg once-daily
Experimental: GSK573719 250mcg
250mcg once-daily via novel dry powder inhaler
Drug: GSK573719 250mcg
250mcg once-daily
Experimental: GSK573719 500mcg
500mcg once-daily via novel dry powder inhaler
Drug: GSK573719 500mcg
500mcg once-daily
Placebo Comparator: Placebo
once-daily via novel dry powder inhaler
Drug: Placebo
once-daily

Detailed Description:

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.

  Eligibility

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

Inclusion Criteria:

  • A signed and dated written informed consent prior to study participation
  • Males or females of non-childbearing potential
  • 40 to 80 years of age
  • COPD diagnosis
  • 10 pack-years history or greater of cigarette smoking
  • Post-bronchodilator FEV1/FVC ratio of 0.70 or less
  • Post-bronchodilator FEV1 of 25 to 70% of predicted normal

Exclusion Criteria:

  • Asthma
  • Other significant respiratory disorders besides COPD, including alpha-1 deficiency
  • Previous lung resection surgery
  • Chest X-ray or CP scan showing clinically significant abnormalities not due to COPD
  • Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening
  • Hospitalization for COPD or pneumonia within 3 months of screening
  • Any significant disease that would put subject at risk through study participation
  • BMI greater than 35
  • Pacemaker
  • Significantly abnormal ECG or clinical lab finding (including Hepatitis B or C)
  • Cancer
  • Allergy or hypersensitivity to anticholinergics or inhaler excipients
  • Diseases that would contraindicate the use of anticholinergics
  • Use of oral corticosteroids within 6 weeks of screening
  • Use of long-acting beta-agonists within 48 hours of screening
  • Use of tiotropium within 14 days of screening
  • Use of theophyllines or anti-leukotrienes within 48 hours of screening
  • Use of short-acting bronchodilators within 4 to 6 hours of screening
  • Use of investigational medicines within 30 days of screening
  • Use of high dose inhaled corticosteroids
  • Use of long-term oxygen therapy, CPAP or NIPPV
  • Participation in acute phase of pulmonary rehabilitation program
  • History of alcohol or drug abuse within 2 years prior to screening
  • History of psychiatric disease limiting validity of consent
  • Affiliation with the investigative site
  • Previous use of GSK573719
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030965

Locations
United States, Kentucky
GSK Investigational Site
Madisonville, Kentucky, United States, 42431
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
United States, South Carolina
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
GSK Investigational Site
Union, South Carolina, United States, 29379
Estonia
GSK Investigational Site
Tallinn, Estonia, 10138
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tallinn, Estonia, 13619
GSK Investigational Site
Tartu, Estonia, 51014
Germany
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65187
GSK Investigational Site
Schwerin, Mecklenburg-vorpommern, Germany, 19055
GSK Investigational Site
Grosshansdorf, Schleswig-holstein, Germany, 22927
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Berlin, Germany, 14057
GSK Investigational Site
Hamburg, Germany, 20253
Poland
GSK Investigational Site
Bialystok, Poland
GSK Investigational Site
Bialystok, Poland, 15-027
GSK Investigational Site
Gidle, Poland, 97-540
GSK Investigational Site
Krakow, Poland, 31-023
GSK Investigational Site
Lublin, Poland, 20-637
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01030965     History of Changes
Other Study ID Numbers: 113589
Study First Received: December 10, 2009
Last Updated: March 15, 2012
Health Authority: Estonia: State Agency of Medicines
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Poland: Ministry of Health & Social Welfare
United States: Food and Drug Administration
Europe: European Medicines Agency

Keywords provided by GlaxoSmithKline:
Chronic Bronchitis
Anticholinergic
Emphysema
Long-acting muscarinic antagonist
COPD

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
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 May 22, 2013