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: June 12, 2014
Last verified: February 2014
  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:
  • Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29 [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.


Secondary Outcome Measures:
  • Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28 [ Time Frame: Baseline, Day 1, and Day 28 ] [ Designated as safety issue: No ]
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean was calculated using the 0-6 hour post-dose measurements at Days 1 and 28, which included pre-dose (30 minutes prior to dosing on Day 1, or 24 hours after the previous day's dose on Day 28), and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between weighted mean at Days 1 and 28 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline, country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.

  • Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 [ Time Frame: Baseline, Day 1, and Day 28 ] [ Designated as safety issue: No ]
    Serial spirometry assessments were conducted on Day 1 and Day 28 over the course of 24 hours and were obtained 0 (Day 28 only), 1, 3, 6, 23, and 24 hours after dosing. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between FEV1 on Days 1 and 28 and Baseline.


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
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: 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, 13619
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tallinn, Estonia, 10138
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
Results First Received: January 9, 2014
Last Updated: June 12, 2014
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
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 August 27, 2014