GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00950807
First received: July 30, 2009
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium
Drug: Placebo
Drug: GSK573179
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of GSK573719 Administered Once- and Twice-Daily 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: 15 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serial FEV1 over 28 hours [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Weighted mean FEV1 over 24 hours [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • ECG measures [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • 24 hour Holter monitoring [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Albuterol use [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Clinical chemistry, haematology, and urinalysis assessments [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Inactive/ excipients only
Active Comparator: Tiotropium
Tiotropium
Drug: Tiotropium
long-acting muscarinic receptor antagonist; 18mcg once-daily
Experimental: Arm 1
GSK573719 1000mcg once daily
Drug: GSK573179
GSK573179, 62.5 mcg, 125mcg, 250 mcg, 500mcg, 10000 mcg once daliy or twice daily
Experimental: Arm 2
GSK573719 500mcg once daily
Drug: GSK573179
GSK573179, 62.5 mcg, 125mcg, 250 mcg, 500mcg, 10000 mcg once daliy or twice daily
Experimental: Arm 3
GSK573719 250mcg once daily
Drug: GSK573179
GSK573179, 62.5 mcg, 125mcg, 250 mcg, 500mcg, 10000 mcg once daliy or twice daily
Experimental: Arm 4
GSK573719 125mcg once daily
Drug: GSK573179
GSK573179, 62.5 mcg, 125mcg, 250 mcg, 500mcg, 10000 mcg once daliy or twice daily
Experimental: Arm 5
GSK573719 62.5 mcg once daily
Drug: GSK573179
GSK573179, 62.5 mcg, 125mcg, 250 mcg, 500mcg, 10000 mcg once daliy or twice daily
Experimental: Arm 6
GSK573719 250mcg twice daily
Drug: GSK573179
GSK573179, 62.5 mcg, 125mcg, 250 mcg, 500mcg, 10000 mcg once daliy or twice daily
Experimental: Arm 7
GSK573719 125mcg twice daily
Drug: GSK573179
GSK573179, 62.5 mcg, 125mcg, 250 mcg, 500mcg, 10000 mcg once daliy or twice daily
Experimental: Arm 8
GSK573719 62.5mcg twice daily
Drug: GSK573179
GSK573179, 62.5 mcg, 125mcg, 250 mcg, 500mcg, 10000 mcg once daliy or twice daily

Detailed Description:

This is multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-way cross-over, incomplete block design study to evaluation of 5 doses of GSK573719 administered once-daily and 3 doses of GSK573719 administered twice-daily over 14 days in subjects with COPD and will include tiotropium as an open-label active control. The pharmacokinetic profile of GSK573719 will also be evaluated.

  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 35 to 70% of predicted normal

Exclusion Criteria:

  • Asthma
  • Other significant respiratory disorders besides COPD, including alpha-1 deficiency
  • Previous lung resection surgery
  • 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, Holter, or clinical lab finding (including Hepatitis B or C)
  • Cancer
  • Allergy or hypersensitivity to anticholinergics or inhaler excipients
  • Diseases that would contra-indicate 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
  • Previous use of GSK573719
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950807

Locations
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85013
United States, California
GSK Investigational Site
San Diego, California, United States, 92117
GSK Investigational Site
Upland, California, United States, 91786
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
United States, South Carolina
GSK Investigational Site
Easley, South Carolina, United States, 29640
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
GSK Investigational Site
Greenville, South Carolina, United States, 29615
GSK Investigational Site
Seneca, South Carolina, United States, 29678
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
GSK Investigational Site
Union, South Carolina, United States, 29379
Germany
GSK Investigational Site
Frankfurt, Hessen, Germany, 60596
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65187
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Hamburg, Germany, 20253
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00950807     History of Changes
Other Study ID Numbers: 113073
Study First Received: July 30, 2009
Last Updated: October 17, 2012
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
United States: Food and Drug Administration
Europe: European Medicines Agency

Keywords provided by GlaxoSmithKline:
Dose ranging
Chronic Bronchitis
Long-acting muscarinic antagonist
cross-over
COPD
Emphysema
Chronic Obstructive Pulmonary Disease (COPD)
anticholinergic

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Muscarinic Antagonists
Tiotropium
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013