Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.
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)
1 other identifier
interventional
186
1 country
37
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2004
Typical duration for phase_4
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2004
CompletedFirst Submitted
Initial submission to the registry
July 19, 2006
CompletedFirst Posted
Study publicly available on registry
July 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2007
CompletedResults Posted
Study results publicly available
March 20, 2018
CompletedJuly 2, 2018
March 1, 2018
3.4 years
July 19, 2006
August 22, 2017
March 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4
BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms). BMD at the lumber spine (L1-L4) was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on Day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value.
Baseline and Week 26, 52, 78, 104, 130, and 156
Secondary Outcomes (1)
Percent Change From Baseline in BMD at the Total Hip
Baseline and Week 26, 52, 78, 104, 130, and 156
Study Arms (2)
Salmeterol 50 mcg BID
EXPERIMENTALParticipants randomized to this arm received salmeterol 50 microgram (mcg), formulated with lactose via the DISKUS™ inhaler one inhalation twice daily (BID) one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. DISCUS is registered trademark product of GlaxoSmithKline.
Fluticasone Propionate/Salmeterol 250/50 mcg BID
EXPERIMENTALParticipants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
Interventions
Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of or evidence for metabolic bone diseases other than osteoporosis or osteopenia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (37)
GSK Investigational Site
Berkeley, California, 94705, United States
GSK Investigational Site
Fullerton, California, 92835, United States
GSK Investigational Site
Rancho Mirage, California, 92270, United States
GSK Investigational Site
San Diego, California, 92103, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
Fort Collins, Colorado, 80528, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site
Hartford, Connecticut, 06105, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Jacksonville, Florida, 32205, United States
GSK Investigational Site
Sarasota, Florida, 34239, United States
GSK Investigational Site
Tamarac, Florida, 33321, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
North Chicago, Illinois, 60064, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Boston, Massachusetts, 02135, United States
GSK Investigational Site
Cadillac, Michigan, 49601, United States
GSK Investigational Site
Saint Charles, Missouri, 63301, United States
GSK Investigational Site
Omaha, Nebraska, 68124, United States
GSK Investigational Site
Bronxville, New York, 10708, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Portland, Oregon, 97213, United States
GSK Investigational Site
Charleston, South Carolina, 29406-7108, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Simpsonville, South Carolina, 29681, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Milan, Tennessee, 38372, United States
GSK Investigational Site
Corsicana, Texas, 75110, United States
GSK Investigational Site
San Antonio, Texas, 78205, United States
GSK Investigational Site
San Antonio, Texas, 78217, United States
GSK Investigational Site
Richmond, Virginia, 23225, United States
GSK Investigational Site
Richmond, Virginia, 23249, United States
GSK Investigational Site
Bellingham, Washington, 98226, United States
GSK Investigational Site
Spokane, Washington, 99202, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
Related Publications (1)
This study has not been published in the scientific literature.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2006
First Posted
July 21, 2006
Study Start
April 28, 2004
Primary Completion
September 6, 2007
Study Completion
September 6, 2007
Last Updated
July 2, 2018
Results First Posted
March 20, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.