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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00633217 |
The purpose of this study is to evaluate the efficacy and safety of the FSC HFA MDI in subjects with COPD. The dose of FSC HFA MDI to be evaluated corresponds to the dose of FSC DISKUS (250/50mcg twice-daily) that is indicated for the treatment of COPD associated with chronic bronchitis in the US. This study will last up to approximately 15 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests and will record their peak expiratory flow measurements daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The FSC HFA MDI used in this study has been approved by FDA for use in asthma while the FSC 250/50mcg DISKUS has been approved for use in asthma and COPD.
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg Drug: Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Double-Dummy, Parallel Group 12-Week Comparison of the Efficacy and Safety of Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a Metered-Dose-Inhaler 230/42mcg Twice-Daily With Fluticasone Propionate/Salmeterol DISKUS 250/50mcg Twice-Daily in Subjects With COPD |
Enrollment: | 247 |
Study Start Date: | March 2008 |
Study Completion Date: | February 2009 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
arm 1: Active Comparator |
Drug: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg
treatment drug
Drug: Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg
treatment drug
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Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Subjects eligible for enrollment in the study must meet all of the following criteria:
A female is eligible to participate in this study if she is of:
child-bearing potential, has a negative pregnancy test (urine) at screen, and one of the following applies:
Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than
1% per year (e.g., Paragard), or,
Double barrier technique simultaneously using two of the following: spermicide, male condom, diaphragm, or female condom
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
neurological, psychiatric, renal, immunological, endocrine/metabolic (including uncontrolled diabetes, hypokalemia or thyroid disease), cardiovascular, neuromuscular, hepatic, gastric, or hematological abnormalities, or peripheral vascular disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would affect the efficacy analysis if the disease/condition exacerbated during the study.
An abnormal and clinically significant 12-lead electrocardiogram (ECG). For the purposes of this study, an abnormal ECG is defined as a 12-lead tracing which is interpreted with (but not limited to) any of the following:
Medication (Exclusion Prior to Visit 1) Short-acting beta-agonists (e.g., albuterol) (6 hours) Ipratropium (6 hours) Ipratropium/albuterol combination product (6 hours) Oral beta-agonists (48 hours) Salmeterol and formoterol (48 hours) Theophylline preparations (48 hours) Tiotropium (48 hours) Long-acting beta-agonist/inhaled corticosteroid combination products (e.g., ADVAIR™ or Symbicort) (30 days) Inhaled corticosteroids (30 days) Oral or parenteral corticosteroids (30 days) Any investigational drug (30 days)
Supplemental oxygen, with the following exceptions:
United States, Alabama | |
GSK Investigational Site | |
Mobile, Alabama, United States, 36608 | |
GSK Investigational Site | |
Jasper, Alabama, United States, 35501 | |
United States, Louisiana | |
GSK Investigational Site | |
Lafayette, Louisiana, United States, 70503 | |
GSK Investigational Site | |
New Orleans, Louisiana, United States, 70115 | |
GSK Investigational Site | |
Sunset, Louisiana, United States, 70584 | |
United States, Missouri | |
GSK Investigational Site | |
St. Charles, Missouri, United States, 63301 | |
United States, North Carolina | |
GSK Investigational Site | |
Elizabeth City, North Carolina, United States, 27909 | |
United States, Pennsylvania | |
GSK Investigational Site | |
Erie, Pennsylvania, United States, 16508 | |
United States, South Carolina | |
GSK Investigational Site | |
Greenville, South Carolina, United States, 29615 | |
GSK Investigational Site | |
Gaffney, South Carolina, United States, 29340 | |
GSK Investigational Site | |
Union, South Carolina, United States, 29309 | |
GSK Investigational Site | |
Charleston, South Carolina, United States, 29406-7108 | |
GSK Investigational Site | |
Spartanburg, South Carolina, United States, 29303 | |
United States, Texas | |
GSK Investigational Site | |
Corsicana, Texas, United States, 75110 | |
United States, Virginia | |
GSK Investigational Site | |
Richmond, Virginia, United States, 23229 | |
United States, West Virginia | |
GSK Investigational Site | |
Morgantown, West Virginia, United States, 26505 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111117 |
Study First Received: | February 19, 2008 |
Last Updated: | June 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00633217 History of Changes |
Health Authority: | United States: Food and Drug Administration |
COPD Fluticasone Propionate Salmeterol |
Hydroflouroalkane HFA MDI DISKUS |
Anti-Inflammatory Agents Neurotransmitter Agents Salmeterol Adrenergic Agents Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Anti-Allergic Agents |
Adrenergic Agonists Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Fluticasone Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Salmeterol Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Respiration Disorders Anti-Asthmatic Agents Anti-Allergic Agents Adrenergic Agonists |
Pharmacologic Actions Lung Diseases, Obstructive Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |