GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00950807
First received: July 30, 2009
Last updated: October 17, 2012
Last verified: October 2012
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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:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Tiotropium bromide
U.S. FDA Resources
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