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ADVAIR® DISKUS® Inhaler (Fluticasone Propionate/Salmeterol) Versus SEREVENT® DISKUS® Inhaler (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations. ADVAIR® DISKUS® Inhaler and SEREVENT® DISKUS® Inhaler Are Trademarks of the GSK Group of Companies.

NCT ID: NCT00144911

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

740 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Pulmonary Disease, Chronic Obstructive

Keywords

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exacerbations breathing chronic obstructive pulmonary disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Salmeterol

Intervention Type DRUG

Fluticasone Propionate/Salmeterol Combination Product

Intervention Type DRUG

Interventions

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Salmeterol

Intervention Type DRUG

Fluticasone Propionate/Salmeterol Combination Product

Intervention Type DRUG

Other Intervention Names

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Salmeterol

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Jasper, Alabama, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Little Rock, Arkansas, United States

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Corona, California, United States

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Los Angeles, California, United States

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Palmdale, California, United States

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Paramount, California, United States

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Rancho Mirage, California, United States

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Riverside, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Sepulveda, California, United States

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Stockton, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Englewood, Colorado, United States

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Wheat Ridge, Colorado, United States

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DeLand, Florida, United States

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Jacksonville, Florida, United States

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Largo, Florida, United States

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North Miami Beach, Florida, United States

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Pensacola, Florida, United States

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Tampa, Florida, United States

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Coeur d'Alene, Idaho, United States

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Champaign, Illinois, United States

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Chicago, Illinois, United States

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Peoria, Illinois, United States

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Evansville, Indiana, United States

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South Bend, Indiana, United States

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Des Moines, Iowa, United States

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Lafayette, Louisiana, United States

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Slidell, Louisiana, United States

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Auburn, Maine, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Kalamazoo, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Kansas City, Missouri, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Cherry Hill, New Jersey, United States

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Summit, New Jersey, United States

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Albuquerque, New Mexico, United States

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Larchmont, New York, United States

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Lewistown, New York, United States

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Elizabeth City, North Carolina, United States

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Raleigh, North Carolina, United States

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Statesville, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Cumberland, Rhode Island, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Simpsonville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Bristol, Tennessee, United States

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Johnson City, Tennessee, United States

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Corsicana, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Abingdon, Virginia, United States

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Charlottesville, Virginia, United States

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Newport News, Virginia, United States

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Gig Harbor, Washington, United States

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Spokane, Washington, United States

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Morgantown, West Virginia, United States

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Calgary, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Grimsby, Ontario, Canada

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Toronto, Ontario, Canada

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Cowansville, Quebec, Canada

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La Malbaie, Quebec, Canada

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Montreal, Quebec, Canada

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Saint-Léonard, Quebec, Canada

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Sainte Jerome, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Sorel-Tracy, Quebec, Canada

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Countries

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Turkey (Türkiye) United States Canada

References

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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.

Reference Type BACKGROUND
PMID: 18614347 (View on PubMed)

Disantostefano RL, Li H, Rubin DB, Stempel DA. Which patients with chronic obstructive pulmonary disease benefit from the addition of an inhaled corticosteroid to their bronchodilator? A cluster analysis. BMJ Open. 2013 Apr 22;3(4):e001838. doi: 10.1136/bmjopen-2012-001838. Print 2013.

Reference Type DERIVED
PMID: 23613569 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Clinical Study Report

View Document

Document Type: Informed Consent Form

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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SCO40043

Identifier Type: -

Identifier Source: org_study_id