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.

October 26, 2016 updated by: GlaxoSmithKline

A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol DISKUS® Inhaler Combination Product 250/50mcg Twice Daily With Salmeterol DISKUS® Inhaler 50mcg Twice Daily on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

Detailed Description

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)

Study Type

Interventional

Enrollment (Actual)

740

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K 3S8
        • GSK Investigational Site
    • Ontario
      • Grimsby, Ontario, Canada, L3M 1P3
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 1N8
        • GSK Investigational Site
    • Quebec
      • Cowansville, Quebec, Canada, J2K 2X9
        • GSK Investigational Site
      • La Malbaie, Quebec, Canada, G5A 1W7
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H3T 1Y6
        • GSK Investigational Site
      • Saint Leonard, Quebec, Canada, H1S 3A9
        • GSK Investigational Site
      • Sainte Jerome, Quebec, Canada, J7Z 5T3
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 4J6
        • GSK Investigational Site
      • Sorel, Quebec, Canada, J3P 1N5
        • GSK Investigational Site
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35294-0012
        • GSK Investigational Site
      • Jasper, Alabama, United States, 35501
        • GSK Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85013
        • GSK Investigational Site
      • Scottsdale, Arizona, United States, 85258
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • Corona, California, United States, 92879
        • GSK Investigational Site
      • Los Angeles, California, United States, 90095-1752
        • GSK Investigational Site
      • Palmdale, California, United States, 93551
        • GSK Investigational Site
      • Paramount, California, United States, 90723
        • GSK Investigational Site
      • Rancho Mirage, California, United States, 92270
        • GSK Investigational Site
      • Riverside, California, United States, 92506
        • GSK Investigational Site
      • Sacramento, California, United States, 95825-5480
        • GSK Investigational Site
      • San Diego, California, United States, 92120
        • GSK Investigational Site
      • Sepulveda, California, United States, 91343
        • GSK Investigational Site
      • Stockton, California, United States, 95207
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • GSK Investigational Site
      • Denver, Colorado, United States, 80206
        • GSK Investigational Site
      • Denver, Colorado, United States, 80204
        • GSK Investigational Site
      • Englewood, Colorado, United States, 80113
        • GSK Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • GSK Investigational Site
    • Florida
      • Deland, Florida, United States, 32720
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32205
        • GSK Investigational Site
      • Largo, Florida, United States, 33770
        • GSK Investigational Site
      • North Miami Beach, Florida, United States, 33179
        • GSK Investigational Site
      • Pensacola, Florida, United States, 32504
        • GSK Investigational Site
      • Tampa, Florida, United States, 33613
        • GSK Investigational Site
    • Idaho
      • Coeur D'Alene, Idaho, United States, 83814
        • GSK Investigational Site
    • Illinois
      • Champaign, Illinois, United States, 61821
        • GSK Investigational Site
      • Chicago, Illinois, United States, 60612
        • GSK Investigational Site
      • Peoria, Illinois, United States, 61602
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47710
        • GSK Investigational Site
      • South Bend, Indiana, United States, 46617
        • GSK Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • GSK Investigational Site
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • GSK Investigational Site
      • Slidell, Louisiana, United States, 70458
        • GSK Investigational Site
    • Maine
      • Auburn, Maine, United States, 04210
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • GSK Investigational Site
      • Worcester, Massachusetts, United States, 01608
        • GSK Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • GSK Investigational Site
      • Rochester, Minnesota, United States, 55905
        • GSK Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • GSK Investigational Site
      • St. Charles, Missouri, United States, 63301
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63122
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • GSK Investigational Site
      • Omaha, Nebraska, United States, 68105
        • GSK Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • GSK Investigational Site
      • Summit, New Jersey, United States, 07091
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • GSK Investigational Site
    • New York
      • Larchmont, New York, United States, 10538
        • GSK Investigational Site
      • Lewistown, New York, United States, 14092
        • GSK Investigational Site
    • North Carolina
      • Elizabeth City, North Carolina, United States, 27909
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27607
        • GSK Investigational Site
      • Statesville, North Carolina, United States, 28625
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44109
        • GSK Investigational Site
      • Columbus, Ohio, United States, 43215
        • GSK Investigational Site
      • Toledo, Ohio, United States, 43614-5809
        • GSK Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
      • Portland, Oregon, United States, 97213
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15243
        • GSK Investigational Site
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • GSK Investigational Site
      • Providence, Rhode Island, United States, 02906
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406-7108
        • GSK Investigational Site
      • Greer, South Carolina, United States, 29651
        • GSK Investigational Site
      • Simpsonville, South Carolina, United States, 29681
        • GSK Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
      • Johnson City, Tennessee, United States, 37601
        • GSK Investigational Site
    • Texas
      • Corsicana, Texas, United States, 75110
        • GSK Investigational Site
      • Fort Worth, Texas, United States, 76104
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • GSK Investigational Site
      • Charlottesville, Virginia, United States, 22908
        • GSK Investigational Site
      • Newport News, Virginia, United States, 23606
        • GSK Investigational Site
    • Washington
      • Gig Harbor, Washington, United States, 98335
        • GSK Investigational Site
      • Spokane, Washington, United States, 99202
        • GSK Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Other Names:
  • Salmeterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of moderate/severe exacerbations over a 52 week treatment period.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Study Protocol
    Information identifier: SCO40043
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: SCO40043
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: SCO40043
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: SCO40043
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: SCO40043
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: SCO40043
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistical Analysis Plan
    Information identifier: SCO40043
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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