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
    • Inclusion criteria:
    • Established clinical history of COPD.
    Inclusion and exclusion criteria
    Inclusion 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
    Contact us
    Location
    GSK Investigational Site
    Fullerton, California, United States, 92835
    Status
    Study Complete
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    Showing 1 - 6 of 37 Results

    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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