Last updated: 11/04/2018 11:56:27

Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® inhaler is a trademark of the GSK group of companies.

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GSK study ID
SCO40041
See study documents
Clinicaltrials.gov ID
NCT00355342
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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)
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Percent change from Baseline in bone mineral density (BMD) at the lumbar spine L1-L4

Timeframe: Baseline and Week 26, 52, 78, 104, 130, and 156

Secondary outcomes:

Percent change from Baseline in BMD at the total hip

Timeframe: Baseline and Week 26, 52, 78, 104, 130, and 156

Interventions:
  • Drug: Salmeterol 50 mcg BID
  • Drug: Fluticasone Propionate/Salmeterol 250/50 mcg BID
  • Device: DISKUS inhaler
    • Enrollment:
    186
    Primary completion date:
    2007-06-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    This study has not been published in the scientific literature.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    April 2004 to September 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • Established clinical history of COPD.
    • Baseline FEV1 <70% predicted normal, and FEV1/FVC ratio of less than 70%.
    • History of or evidence for metabolic bone diseases other than osteoporosis or osteopenia.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Hartford, Connecticut, United States, 06105
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Chicago, Illinois, United States, 60064
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fort Collins, Colorado, United States, 80528
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Corsicana, Texas, United States, 75110
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60612
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fullerton, California, United States, 92835
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Charles, Missouri, United States, 63301
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sarasota, Florida, United States, 34239
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68124
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spartanburg, South Carolina, United States, 29303
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rancho Mirage, California, United States, 92270
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Milan, Tennessee, United States, 38372
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tamarac, Florida, United States, 33321
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Simpsonville, South Carolina, United States, 29681
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Walnut Creek, California, United States, 94598
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cadillac, Michigan, United States, 49601
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Greer, South Carolina, United States, 29651
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wheat Ridge, Colorado, United States, 80033
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Lauderdale, Florida, United States, 33316
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23225
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97213
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bronxville, New York, United States, 10708
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kingsport, Tennessee, United States, 37660
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02135
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92103
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78217
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charleston, South Carolina, United States, 29406-7108
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23249
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berkeley, California, United States, 94705
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wichita, Kansas, United States, 67207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30342
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bellingham, Washington, United States, 98226
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-06-09
    Actual study completion date
    2007-06-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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