Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)

October 26, 2016 updated by: GlaxoSmithKline

A Randomized, 24-week, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of ARIFLO® (15mg BID) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study was designed to determine if the investigational drug is effective and safe in individuals with COPD (chronic pulmonary disease)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 3

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • GSK Investigational Site
      • Jasper, Alabama, United States, 35501
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • GSK Investigational Site
      • Tempe, Arizona, United States, 85282
        • GSK Investigational Site
    • California
      • Berkeley, California, United States, 94705
        • GSK Investigational Site
      • Carmichael, California, United States, 95608
        • GSK Investigational Site
      • Fullerton, California, United States, 92835
        • GSK Investigational Site
      • Long Beach, California, United States, 90806
        • GSK Investigational Site
      • Long Beach, California, United States, 90822
        • GSK Investigational Site
      • Los Angeles, California, United States, 90048
        • GSK Investigational Site
      • Murrieta, California, United States, 92562
        • GSK Investigational Site
      • Rancho Mirage, California, United States, 92270
        • GSK Investigational Site
      • Riverside, California, United States, 92805
        • GSK Investigational Site
      • Sacramento, California, United States, 95823
        • GSK Investigational Site
      • San Diego, California, United States, 92103
        • GSK Investigational Site
      • San Diego, California, United States, 92120
        • GSK Investigational Site
      • San Jose, California, United States, 95117
        • GSK Investigational Site
      • Sepulveda, California, United States, 91343
        • GSK Investigational Site
      • Stockton, California, United States, 95207
        • GSK Investigational Site
      • Torrance, California, United States, 90509
        • GSK Investigational Site
      • Vista, California, United States, 92083
        • GSK Investigational Site
      • Walnut Creek, California, United States, 94598
        • GSK Investigational Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • GSK Investigational Site
      • Colorado Springs, Colorado, United States, 80907
        • GSK Investigational Site
      • Denver, Colorado, United States, 80230
        • GSK Investigational Site
      • Englewood, Colorado, United States, 80112
        • GSK Investigational Site
      • Fort Collins, Colorado, United States, 80528
        • GSK Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • GSK Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • GSK Investigational Site
      • Stamford, Connecticut, United States, 06902
        • GSK Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • GSK Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • GSK Investigational Site
      • Brandon, Florida, United States, 33511
        • GSK Investigational Site
      • Deland, Florida, United States, 32720
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • GSK Investigational Site
      • Largo, Florida, United States, 33770
        • GSK Investigational Site
      • Longwood, Florida, United States, 32779
        • GSK Investigational Site
      • Melbourne, Florida, United States, 32935
        • GSK Investigational Site
      • Panama City, Florida, United States, 32405
        • GSK Investigational Site
      • Pensacola, Florida, United States, 32504
        • GSK Investigational Site
      • Tamarac, Florida, United States, 33321
        • GSK Investigational Site
      • Tampa, Florida, United States, 33613
        • GSK Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Decatur, Georgia, United States, 30033
        • GSK Investigational Site
    • Idaho
      • Coeur D'Alene, Idaho, United States, 83814
        • GSK Investigational Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47710
        • GSK Investigational Site
      • South Bend, Indiana, United States, 46617
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67207
        • GSK Investigational Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • GSK Investigational Site
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • GSK Investigational Site
      • New Orleans, Louisiana, United States, 70119
        • GSK Investigational Site
      • Slidell, Louisiana, United States, 70461
        • GSK Investigational Site
      • Sunset, Louisiana, United States, 70584
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • GSK Investigational Site
    • Michigan
      • Cadillac, Michigan, United States, 49601
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • GSK Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • GSK Investigational Site
      • St. Charles, Missouri, United States, 63301
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63141
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63122
        • GSK Investigational Site
    • Montana
      • Billings, Montana, United States, 59102
        • GSK Investigational Site
      • Missoula, Montana, United States, 59808
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • GSK Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • GSK Investigational Site
    • New York
      • Bronxville, New York, United States, 10708
        • GSK Investigational Site
      • Cortland, New York, United States, 14850
        • GSK Investigational Site
      • Larchmont, New York, United States, 10538
        • GSK Investigational Site
      • New York, New York, United States, 10016
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28207
        • GSK Investigational Site
      • Elizabeth City, North Carolina, United States, 27909
        • GSK Investigational Site
      • High Point, North Carolina, United States, 27262
        • GSK Investigational Site
      • Statesville, North Carolina, United States, 28625
        • GSK Investigational Site
    • Ohio
      • Chardon, Ohio, United States, 44024
        • GSK Investigational Site
      • Columbus, Ohio, United States, 43215
        • GSK Investigational Site
      • Dayton, Ohio, United States, 45406
        • GSK Investigational Site
      • Sylvania, Ohio, United States, 43560
        • GSK Investigational Site
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • GSK Investigational Site
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
      • Portland, Oregon, United States, 97213
        • GSK Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • GSK Investigational Site
      • Downington, Pennsylvania, United States, 19335
        • GSK Investigational Site
      • Elverson, Pennsylvania, United States, 19520
        • GSK Investigational Site
      • Erie, Pennsylvania, United States, 16508
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15243
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15218
        • GSK Investigational Site
      • Swarthmore, Pennsylvania, United States, 19081
        • GSK Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406-7108
        • GSK Investigational Site
      • Gaffney, South Carolina, United States, 29340
        • 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
      • Chattanooga, Tennessee, United States, 37403
        • GSK Investigational Site
      • Johnson City, Tennessee, United States, 37601
        • GSK Investigational Site
      • Knoxville, Tennessee, United States, 37920
        • GSK Investigational Site
    • Texas
      • Corsicana, Texas, United States, 75110
        • GSK Investigational Site
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Fort Worth, Texas, United States, 76104
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78217
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78205
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23225
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23229
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, United States, 98225
        • GSK Investigational Site
      • Spokane, Washington, United States, 99204
        • GSK Investigational Site
      • Spokane, Washington, United States, 99207
        • GSK Investigational Site
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209-0996
        • 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 and a history of cigarette smoking.

Exclusion criteria:

  • Significant heart or lung disease not associated with COPD.
  • Significant stomach or intestinal disease.

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
Drug: cilomilast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
measure of lung function and quality of life in patients with COPD

Secondary Outcome Measures

Outcome Measure
exacerbations in patients with COPD

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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.

Helpful Links

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

November 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

February 17, 2005

First Submitted That Met QC Criteria

February 17, 2005

First Posted (Estimate)

February 18, 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIL103657

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. Statistical Analysis Plan
    Information identifier: CIL103657
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: CIL103657
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: CIL103657
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: CIL103657
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: CIL103657
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: CIL103657
    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.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe