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Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00355342
First Posted: July 21, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits will include lung function tests and scans of your bones. The purpose of this study is to determine the effect of the steroid component of an inhaled product on bone mineral density in patients with Chronic Obstructive Pulmonary Disease (COPD).

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive Drug: fluticasone propionate/salmeterol powder Drug: salmeterol powder Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group Clinical Trial Evaluating the Effect of the Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Twice Daily Via DISKUS® Inhaler Versus Salmeterol 50mcg Twice Daily Via DISKUS® Inhaler on Bone Mineral Density in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Bone mineral density measured at the lumbar spine.

Secondary Outcome Measures:
  • Bone mineral density measured at the total hip.

Enrollment: 180
Study Start Date: April 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: fluticasone propionate/salmeterol powder Drug: salmeterol powder
Other Name: fluticasone propionate/salmeterol powder

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Established clinical history of COPD.
  • Baseline FEV1 <70% predicted normal, and FEV1/FVC ratio of less than 70%.
  • Smoking history of at least 10 pack-years, where both current and former smokers will be eligible.
  • Must have at least one native, evaluable hip.

Exclusion criteria:

  • History of or evidence for metabolic bone diseases other than osteoporosis or osteopenia.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355342


  Hide Study Locations
Locations
United States, California
GSK Investigational Site
Berkeley, California, United States, 94705
GSK Investigational Site
Fullerton, California, United States, 92835
GSK Investigational Site
Rancho Mirage, California, United States, 92270
GSK Investigational Site
San Diego, California, United States, 92103
GSK Investigational Site
Walnut Creek, California, United States, 94598
United States, Colorado
GSK Investigational Site
Fort Collins, Colorado, United States, 80528
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
GSK Investigational Site
Hartford, Connecticut, United States, 06105
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
GSK Investigational Site
Jacksonville, Florida, United States, 32205
GSK Investigational Site
Sarasota, Florida, United States, 34239
GSK Investigational Site
Tamarac, Florida, United States, 33321
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
North Chicago, Illinois, United States, 60064
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02135
United States, Michigan
GSK Investigational Site
Cadillac, Michigan, United States, 49601
United States, Missouri
GSK Investigational Site
St. Charles, Missouri, United States, 63301
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68124
United States, New York
GSK Investigational Site
Bronxville, New York, United States, 10708
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97213
United States, South Carolina
GSK Investigational Site
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
United States, Tennessee
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
GSK Investigational Site
Milan, Tennessee, United States, 38372
United States, Texas
GSK Investigational Site
Corsicana, Texas, United States, 75110
GSK Investigational Site
San Antonio, Texas, United States, 78205
GSK Investigational Site
San Antonio, Texas, United States, 78217
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23225
GSK Investigational Site
Richmond, Virginia, United States, 23249
United States, Washington
GSK Investigational Site
Bellingham, Washington, United States, 98226
GSK Investigational Site
Spokane, Washington, United States, 99202
GSK Investigational Site
Spokane, Washington, United States, 99204
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
This study has not been published in the scientific literature.

Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: SCO40041
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: SCO40041
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: SCO40041
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SCO40041
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SCO40041
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: SCO40041
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: SCO40041
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00355342     History of Changes
Other Study ID Numbers: SCO40041
First Submitted: July 19, 2006
First Posted: July 21, 2006
Last Update Posted: October 12, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by GlaxoSmithKline:
Osteoporosis
Bone Mineral Density
Osteopenia
Chronic Obstructive Pulmonary Disease
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics