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Advair® DISKUS® (Fluticasone Propionate/Salmeterol) Versus Serevent® DISKUS® (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Intervention: Salmeterol (Drug); Fluticasone Propionate/Salmeterol Combination Product (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

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

Summary

This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by the FDA for use in patients with COPD.

Clinical Details

Official title: See Detailed Description

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Rate of moderate/severe exacerbations over a 52 week treatment period.

Secondary outcome: The time until the first moderate/severe exacerbation, the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year.

Detailed description: A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 250/50mcg BID with Salmeterol DISKUS 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Eligibility

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

Criteria:

Inclusion Criteria:

- Diagnosis of COPD (chronic obstructive pulmonary disease).

- Current or previous cigarette smokers with a smoking history of at least 10

pack-years.

- History of a least 1 COPD exacerbation in the 12 months prior to screening.

- Forced expiratory volume in one second (FEV1) of less than or equal to 50% of

predicted normal. Exclusion Criteria:

- Current diagnosis of asthma.

- Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1

antitrypsin deficiency, cystic fibrosis, or active tuberculosis).

- Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled

and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.

- Lung resection surgery within 1 year of screening.

- Abnormal and clinically significant ECG findings at screening.

- Other inclusion and exclusion criteria will be evaluated at the first study visit.

Locations and Contacts

GSK Investigational Site, Birmingham, Alabama 35209, United States

GSK Investigational Site, Birmingham, Alabama 35294-0012, United States

GSK Investigational Site, Jasper, Alabama 35501, United States

GSK Investigational Site, Calgary, Alberta T2N 4N1, Canada

GSK Investigational Site, Glendale, Arizona 85306, United States

GSK Investigational Site, Phoenix, Arizona 85013, United States

GSK Investigational Site, Scottsdale, Arizona 85258, United States

GSK Investigational Site, Little Rock, Arkansas 72205, United States

GSK Investigational Site, Corona, California 92879, United States

GSK Investigational Site, Los Angeles, California 90095-1752, United States

GSK Investigational Site, Palmdale, California 93551, United States

GSK Investigational Site, Paramount, California 90723, United States

GSK Investigational Site, Rancho Mirage, California 92270, United States

GSK Investigational Site, Riverside, California 92506, United States

GSK Investigational Site, San Diego, California 92120, United States

GSK Investigational Site, Sepulveda, California 91343, United States

GSK Investigational Site, Stockton, California 95207, United States

GSK Investigational Site, Colorado Springs, Colorado 80907, United States

GSK Investigational Site, Denver, Colorado 80204, United States

GSK Investigational Site, Denver, Colorado 80206, United States

GSK Investigational Site, Englewood, Colorado 80113, United States

GSK Investigational Site, Wheat Ridge, Colorado 80033, United States

GSK Investigational Site, Deland, Florida 32720, United States

GSK Investigational Site, Jacksonville, Florida 32205, United States

GSK Investigational Site, Largo, Florida 33770, United States

GSK Investigational Site, North Miami Beach, Florida 33179, United States

GSK Investigational Site, Pensacola, Florida 32504, United States

GSK Investigational Site, Tampa, Florida 33613, United States

GSK Investigational Site, Coeur D'Alene, Idaho 83814, United States

GSK Investigational Site, Champaign, Illinois 61821, United States

GSK Investigational Site, Chicago, Illinois 60612, United States

GSK Investigational Site, Peoria, Illinois 61602, United States

GSK Investigational Site, Evansville, Indiana 47710, United States

GSK Investigational Site, South Bend, Indiana 46617, United States

GSK Investigational Site, Des Moines, Iowa 50309, United States

GSK Investigational Site, Lafayette, Louisiana 70503, United States

GSK Investigational Site, Slidell, Louisiana 70458, United States

GSK Investigational Site, Winnipeg, Manitoba R2K 3S8, Canada

GSK Investigational Site, Boston, Massachusetts 02118, United States

GSK Investigational Site, Worcester, Massachusetts 01608, United States

GSK Investigational Site, Kalamazoo, Michigan 49009, United States

GSK Investigational Site, Minneapolis, Minnesota 55407, United States

GSK Investigational Site, Rochester, Minnesota 55905, United States

GSK Investigational Site, Kansas City, Missouri 64108, United States

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

GSK Investigational Site, St. Louis, Missouri 63122, United States

GSK Investigational Site, Omaha, Nebraska 68134, United States

GSK Investigational Site, Omaha, Nebraska 68105, United States

GSK Investigational Site, Cherry Hill, New Jersey 08003, United States

GSK Investigational Site, Summit, New Jersey 07091, United States

GSK Investigational Site, Albuquerque, New Mexico 87108, United States

GSK Investigational Site, Larchmont, New York 10538, United States

GSK Investigational Site, Lewistown, New York 14092, United States

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

GSK Investigational Site, Raleigh, North Carolina 27607, United States

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

GSK Investigational Site, Cincinnati, Ohio 45219, United States

GSK Investigational Site, Cincinnati, Ohio 45231, United States

GSK Investigational Site, Cleveland, Ohio 44109, United States

GSK Investigational Site, Columbus, Ohio 43215, United States

GSK Investigational Site, Toledo, Ohio 43614-5809, United States

GSK Investigational Site, Tulsa, Oklahoma 74135, United States

GSK Investigational Site, Grimsby, Ontario L3M 1P3, Canada

GSK Investigational Site, Toronto, Ontario M5G 1N8, Canada

GSK Investigational Site, Eugene, Oregon 97401, United States

GSK Investigational Site, Medford, Oregon 97504, United States

GSK Investigational Site, Portland, Oregon 97213, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19140, United States

GSK Investigational Site, Pittsburgh, Pennsylvania 15243, United States

GSK Investigational Site, Cowansville, Quebec J2K 2X9, Canada

GSK Investigational Site, La Malbaie, Quebec G5A 1W7, Canada

GSK Investigational Site, Montreal, Quebec H3T 1Y6, Canada

GSK Investigational Site, Saint Leonard, Quebec H1S 3A9, Canada

GSK Investigational Site, Sainte Jerome, Quebec J7Z 5T3, Canada

GSK Investigational Site, Sainte-Foy, Quebec G1V 4G5, Canada

GSK Investigational Site, Sherbrooke, Quebec J1H 4J6, Canada

GSK Investigational Site, Sorel, Quebec J3P 1N5, Canada

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

GSK Investigational Site, Providence, Rhode Island 02906, United States

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

GSK Investigational Site, Greer, South Carolina 29651, United States

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

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

GSK Investigational Site, Bristol, Tennessee 37620, United States

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

GSK Investigational Site, Corsicana, Texas 75110, United States

GSK Investigational Site, Houston, Texas 77030, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

GSK Investigational Site, Abingdon, Virginia 24210, United States

GSK Investigational Site, Charlottesville, Virginia 22908, United States

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

GSK Investigational Site, Gig Harbor, Washington 98335, United States

GSK Investigational Site, Spokane, Washington 99202, United States

GSK Investigational Site, Tacoma, Washington 98405, United States

GSK Investigational Site, Morgantown, West Virginia 26505, United States

Additional Information

Related publications:

Ferguson GT, Anzueto A, Fei R, Emmett A, Knobil K, Kalberg C. Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations. Respir Med. 2008 Aug;102(8):1099-108. doi: 10.1016/j.rmed.2008.04.019. Epub 2008 Jul 9.

Starting date: October 2004
Last updated: March 1, 2013

Page last updated: August 23, 2015

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