FLUTICASONE PROPIONATE/SALMETEROL 250/50mcg Plus TIOTROPIUM BROMIDE 18mcg Versus TIOTROPIUM BROMIDE in COPD Patients

Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)

Intervention: FLuticasone Propionate/Salmeterol (Drug); Tiotropium Bromide (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718

The purpose of the study is to determine the efficacy and safety of the combination of two drugs (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT 250/50mcg plus TIOTROPIUM 18mcg) compared to a single drug alone (TIOTROPIUM BROMIDE 18mcg) in patients with COPD.

Official title: A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS 250/50mcg Plus SPIRIVA HANDIHALER Versus SPIRIVA HANDIHALER Plus Placebo DISKUS in Subjects With Chronic Obstructive Pulmonary Disease (COPD). SPIRIVA and HANDIHALER Are Trade Marks of Boehringer Ingelheim

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: morning pre dose forced expiratory volume in one second

Secondary outcome:

Two hour post dose forced expiratory volume in one second

morning pre dose forced vital capacity

two hour post dose forced vital capacity

morning pre dose inspiratory capacity

Scores on the CRQ SAS

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- COPD diagnosis

- At least 10 pack year smoking history

- Post-albuterol FEV1 greater than or equal to 40% to less than or equal to 80% of

predicted normal

- An FEV1/FVC ratio of less than or equal to 0. 70

Exclusion Criteria:

- Current diagnosis of asthma

- Other respiratory disorder other than COPD

- Abnormal and clinical significant ECG

- Chest x-ray clinically significant abnormality not believed to be due to COPD

- Body Mass Index of greater than or equal to 40/kg/m2

- Use of Long Term Oxygen Therapy

- Lung resection surgery

- Women pregnant or lactating at Visit 1

- Previously diagnosed cancer unless in complete remission for 2 years at Visit 1

US GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Investigational Site, Mobile, Alabama 36608, United States; Withdrawn

GSK Investigational Site, Riverside, California 92506, United States; Recruiting

GSK Investigational Site, Colorado Springs, Colorado 80909, United States; Withdrawn

GSK Investigational Site, Fort Collins, Colorado 80528, United States; Recruiting

GSK Investigational Site, Stamford, Connecticut 06902, United States; Withdrawn

GSK Investigational Site, Miami, Florida 33186, United States; Withdrawn

GSK Investigational Site, Deland, Florida 32720, United States; Recruiting

GSK Investigational Site, Clearwater, Florida 33756, United States; Recruiting

GSK Investigational Site, Naranja, Florida 33032, United States; Recruiting

GSK Investigational Site, Coeur D'Alene, Idaho 83814, United States; Active, not recruiting

GSK Investigational Site, Gillespie, Illinois 62033, United States; Recruiting

GSK Investigational Site, Elkhart, Indiana 46514, United States; Recruiting

GSK Investigational Site, Olathe, Kansas 66061, United States; Not yet recruiting

GSK Investigational Site, Louisville, Kentucky 40207, United States; Active, not recruiting

GSK Investigational Site, Shreveport, Louisiana 71103, United States; Not yet recruiting

GSK Investigational Site, Sunset, Louisiana 70584, United States; Recruiting

GSK Investigational Site, Minneapolis, Minnesota 55417, United States; Withdrawn

GSK Investigational Site, St. Charles, Missouri 63301, United States; Recruiting

GSK Investigational Site, Omaha, Nebraska 68131, United States; Not yet recruiting

GSK Investigational Site, Ocean, New Jersey 7712, United States; Withdrawn

GSK Investigational Site, Albany, New York 12205, United States; Recruiting

GSK Investigational Site, Statesville, North Carolina 28625, United States; Recruiting

GSK Investigational Site, Elizabeth City, North Carolina 27909, United States; Recruiting

GSK Investigational Site, Mooresville, North Carolina 28117, United States; Recruiting

GSK Investigational Site, Cincinnati, Ohio 45231, United States; Recruiting

GSK Investigational Site, Cleveland, Ohio 44122, United States; Recruiting

GSK Investigational Site, Dayton, Ohio 45406, United States; Withdrawn

GSK Investigational Site, Medford, Oregon 97504, United States; Withdrawn

GSK Investigational Site, Erie, Pennsylvania 16508, United States; Recruiting

GSK Investigational Site, Cumberland, Rhode Island 02864, United States; Recruiting

GSK Investigational Site, Simpsonville, South Carolina 29681, United States; Recruiting

GSK Investigational Site, Union, South Carolina 29309, United States; Recruiting

GSK Investigational Site, Charleston, South Carolina 29406-7108, United States; Recruiting

GSK Investigational Site, Gaffney, South Carolina 29340, United States; Recruiting

GSK Investigational Site, Spartanburg, South Carolina 29303, United States; Recruiting

GSK Investigational Site, Spartanburg, South Carolina 29303, United States; Withdrawn

GSK Investigational Site, Greenville, South Carolina 29615, United States; Recruiting

GSK Investigational Site, Charleston, South Carolina 29406, United States; Withdrawn

GSK Investigational Site, Milan, Tennessee 38358, United States; Recruiting

GSK Investigational Site, Johnson City, Tennessee 37601, United States; Withdrawn

GSK Investigational Site, Boerne, Texas 78006, United States; Recruiting

GSK Investigational Site, Plano, Texas 75024, United States; Active, not recruiting

GSK Investigational Site, Houston, Texas 77054, United States; Recruiting

GSK Investigational Site, Houston, Texas 77030, United States; Not yet recruiting

GSK Investigational Site, West Jordan, Utah 84088, United States; Recruiting

GSK Investigational Site, Weber City, Virginia 24290, United States; Withdrawn

GSK Investigational Site, Newport News, Virginia 23606, United States; Recruiting

GSK Investigational Site, Richmond, Virginia 23229, United States; Recruiting

GSK Investigational Site, Morgantown, West Virginia 26505, United States; Not yet recruiting

Starting date: December 2008
Ending date: October 2010
Last updated: February 12, 2009