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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01030965 |
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 Chronic Bronchitis Emphysema |
Drug: GSK573719 125mcg Drug: GSK573719 250mcg Drug: GSK573719 500mcg Drug: Placebo |
Phase II |
| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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, 13619 | |
| GSK Investigational Site | |
| Tallinn, Estonia, 13419 | |
| 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 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01030965 History of Changes |
| Other Study ID Numbers: | 113589 |
| Study First Received: | December 10, 2009 |
| Last Updated: | March 3, 2011 |
| 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 |
|
Chronic Bronchitis Anticholinergic Emphysema Long-acting muscarinic antagonist COPD |
|
Bronchitis Bronchitis, Chronic Chronic Disease Emphysema Pulmonary Emphysema Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |
Respiratory Tract Infections Disease Attributes Pathologic Processes Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |