Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations

NCT ID: NCT00115492

Last Updated: 2017-01-20

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

797 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-06-30

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 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 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)

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Fluticasone Propionate/Salmeterol Combination Product

Intervention Type DRUG

Salmeterol

Intervention Type DRUG

Other Intervention Names

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Fluticasone Propionate/Salmeterol Combination Product

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of COPD.
* Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
* History of at 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

* 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

Jasper, Alabama, United States

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Mobile, Alabama, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Berkeley, California, United States

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Fullerton, 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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Vista, California, United States

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Fort Collins, Colorado, United States

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Stamford, Connecticut, United States

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Atlantis, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Pensacola, Florida, United States

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Sarasota, Florida, United States

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Tamarac, Florida, United States

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Atlanta, Georgia, United States

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Woodstock, Georgia, United States

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Springfield, Illinois, United States

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Elkhart, Indiana, United States

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Evansville, Indiana, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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South Bend, Indiana, United States

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Iowa City, Iowa, United States

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Olathe, Kansas, United States

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Madisonville, Kentucky, United States

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Lafayette, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Sunset, Louisiana, United States

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Auburn, Maine, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Saint Joseph, Michigan, United States

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Minneapolis, Minnesota, United States

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Chesterfield, Missouri, United States

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Jefferson 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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Billings, Montana, United States

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Butte, Montana, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Absecon, New Jersey, United States

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Albany, New York, United States

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Bay Shore, New York, United States

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Ithaca, New York, United States

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Larchmont, New York, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Elizabeth City, North Carolina, United States

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High Point, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Canton, Ohio, United States

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Chardon, Ohio, United States

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Mogadore, Ohio, United States

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Lake Oswego, Oregon, United States

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Erie, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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McKeesport, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Providence, Rhode Island, United States

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Gaffney, 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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Chattanooga, Tennessee, United States

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Johnson City, Tennessee, United States

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Kingsport, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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New Braunfels, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Marcos, Texas, United States

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Abingdon, Virginia, United States

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Lynchburg, Virginia, United States

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Newport News, Virginia, United States

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Richmond, Virginia, United States

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Bellingham, Washington, United States

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Gig Harbor, Washington, United States

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Kirkland, Washington, United States

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Spokane, Washington, United States

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Morgantown, West Virginia, United States

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La Crosse, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Saint John, New Brunswick, Canada

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Bay Roberts, Newfoundland and Labrador, Canada

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Holyrood, Newfoundland and Labrador, Canada

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Grimsby, Ontario, Canada

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London, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Bonaventure, Quebec, Canada

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Chandler, Quebec, Canada

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Charlesbourg, Quebec, Canada

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Gatineau, Quebec, Canada

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Saint-Léonard, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Countries

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United States Canada

References

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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: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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SCO100250

Identifier Type: -

Identifier Source: org_study_id

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