Pulmonary Disease, Chronic ObstructivePhase 4NCT00355342

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

A Phase 4 study testing Salmeterol 50 mcg BID, Fluticasone Propionate/Salmeterol 250/50 mcg BID and DISKUS inhaler in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Salmeterol 50 mcg BID, Fluticasone Propionate/Salmeterol 250/50 mcg BID and DISKUS inhaler
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 186 participants
Where: 37 sitesUnited States
Study dates: 28 Apr 2004to 6 Sep 2007
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

History of or evidence for metabolic bone diseases other than osteoporosis or osteopenia.

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

United States37 sites

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

Other trials in United States

About this study

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)

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Salmeterol 50 mcg BID, Fluticasone Propionate/Salmeterol 250/50 mcg BID, DISKUS inhaler
Keywords: Osteoporosis, Bone Mineral Density, Osteopenia, Chronic Obstructive Pulmonary Disease, COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Osteoporosis, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Salmeterol 50 mcg BIDDrug
Also called GR33343G
Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
Fluticasone Propionate/Salmeterol 250/50 mcg BIDDrug
Also called CCI18781/GR33343G
Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
DISKUS inhalerDevice
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.

Study groups in NCT00355342
Study group	Role	What they receive
Salmeterol 50 mcg BID	Experimental	Participants 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. Receives: Drug: Salmeterol 50 mcg BID; Device: DISKUS inhaler
Fluticasone Propionate/Salmeterol 250/50 mcg BID	Experimental	Participants 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. Receives: Drug: Fluticasone Propionate/Salmeterol 250/50 mcg BID; Device: DISKUS inhaler

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 26, 52, 78, 104, 130, and 156

Secondary outcomes (1)

Percent Change From Baseline in BMD at the Total Hip
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 total hip 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.
Measured: Baseline and Week 26, 52, 78, 104, 130, and 156

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Apr 20046 Sep 2007

First posted21 Jul 2006 (estimated)
Study start28 Apr 2004
Primary completion6 Sep 2007
Study completion6 Sep 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00355342
Sponsor's protocol ID: SCO40041
Status last verified: Mar 2018
First submitted: 19 Jul 2006
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

This study has not been published in the scientific literature.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00355342
Acronym / sponsor ID: SCO40041
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Osteoporosis, Bone Mineral Density, Osteopenia, Chronic Obstructive Pulmonary Disease, COPD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 186 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 28 Apr 2004 (actual)
Primary completion: 6 Sep 2007 (actual)
Study completion: 6 Sep 2007 (actual)
First posted: 21 Jul 2006 (estimated)
Results: Posted 20 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Salmeterol 50 mcg BID	Experimental	Drug: Salmeterol 50 mcg BID, Device: DISKUS inhalerParticipants 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	Experimental	Drug: Fluticasone Propionate/Salmeterol 250/50 mcg BID, Device: DISKUS inhalerParticipants 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.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (1 listed)

History of or evidence for metabolic bone diseases other than osteoporosis or osteopenia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Salmeterol 50 mcg BIDAlso: GR33343GSalmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.	Drug	Salmeterol 50 mcg BID
Fluticasone Propionate/Salmeterol 250/50 mcg BIDAlso: CCI18781/GR33343GFluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.	Drug	Fluticasone Propionate/Salmeterol 250/50 mcg BID
DISKUS inhalerEach 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.	Device	Fluticasone Propionate/Salmeterol 250/50 mcg BID, Salmeterol 50 mcg BID

Primary outcome

Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4
Time frame: Baseline and Week 26, 52, 78, 104, 130, and 156
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.

1 secondary outcome

Percent Change From Baseline in BMD at the Total Hip
Time frame: Baseline and Week 26, 52, 78, 104, 130, and 156

Results and safety

Results posted to the registry on 20 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Salmeterol 50 mcg BID	94	55
Fluticasone Propionate/Salmeterol 250/50 mcg BID	92	56

Primary outcome: Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4

Time frame: Baseline and Week 26, 52, 78, 104, 130, and 156. Mean (Standard Error). Unit: Percent Change

Measure	Salmeterol 50 mcg BID n = 84	Fluticasone Propionate/Salmeterol 250/50 mcg BID n = 82
Week 26	0.5 (0.33)	0.2 (0.40)
Week 52	0.8 (0.39)	1.3 (0.43)
Week 78	1.3 (0.52)	1.0 (0.64)
Week 104	0.9 (0.55)	0.8 (0.71)
Week 130	0.3 (0.66)	1.0 (0.81)
Week 156	0.3 (0.68)	1.9 (0.88)

Salmeterol 50 mcg BID vs Fluticasone Propionate/Salmeterol 250/50 mcg BID: Mean Difference (Final Values): 0.8 (95% CI 0.06 to 1.49)

Population analysed: The Safety population - Safety population was defined as all randomized participants who are at least 50% compliant with taking study drug and have a post-Baseline BMD scan. Only those participants available at the specified time points were analyzed.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 160 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Salmeterol 50 mcg BID	33 of 94 (35.1%)	63 of 94 (67%)	7 of 94
Fluticasone Propionate/Salmeterol 250/50 mcg BID	32 of 92 (34.8%)	72 of 92 (78.3%)	5 of 92

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundThis study has not been published in the scientific literature.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

37 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4 (time frame: Baseline and Week 26, 52, 78, 104, 130, and 156). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00355342, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018; AzTrials last refreshed its copy on 30 Oct 2026.