28-day Repeat Dose Study of GSK573719
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01030965
First received: December 10, 2009
Last updated: March 15, 2012
Last verified: March 2012
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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