Pulmonary Disease, Chronic ObstructivePhase 4NCT00115492

Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations

A Phase 4 study testing Fluticasone Propionate/Salmeterol Combination Product and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 110 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Fluticasone Propionate/Salmeterol Combination Product and Salmeterol
How many people: 797 participants
Where: 110 sitesin 2 countries
Study dates: Dec 2004to Jun 2007
Phase: Phase 4
Are there results?: None posted in the registry

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

Diagnosis of COPD.
Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
History of at least 1 COPD exacerbation in the 12 months prior to screening.
Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.

Who cannot join

Diagnosis of asthma.
Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
Lung resection surgery within 1 year of screening.
Abnormal and clinically significant ECG findings at screening.
Other inclusion and exclusion criteria will be evaluated at the first study visit.

Trial locations and contacts

110 sites in 2 countries.

Country

City, postcode or hospital

110 sites in 2 countries

United States95 sites

GSK Investigational Site
Abingdon, Virginia, 24210
GSK Investigational Site
Absecon, New Jersey, 08201
GSK Investigational Site
Albany, New York, 12205
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Atlantis, Florida, 33462
GSK Investigational Site
Auburn, Maine, 04210
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Bay Shore, New York, 11706
GSK Investigational Site
Bellingham, Washington, 98226
GSK Investigational Site
Berkeley, California, 94705
GSK Investigational Site
Billings, Montana, 59102
GSK Investigational Site
Boston, Massachusetts, 02135
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Butte, Montana, 59701
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Chapel Hill, North Carolina, 27599
GSK Investigational Site
Chardon, Ohio, 44024
GSK Investigational Site
Charlotte, North Carolina, 28207
GSK Investigational Site
Chattanooga, Tennessee, 37403
GSK Investigational Site
Chesterfield, Missouri, 63017
GSK Investigational Site
Clearwater, Florida, 33756
GSK Investigational Site
Dallas, Texas, 75390-9016
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
East Providence, Rhode Island, 02914
GSK Investigational Site
Elizabeth City, North Carolina, 27909
GSK Investigational Site
Elkhart, Indiana, 46154
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Evansville, Indiana, 47710
GSK Investigational Site
Evansville, Indiana, 47714
GSK Investigational Site
Fort Collins, Colorado, 80528
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Fullerton, California, 92835
GSK Investigational Site
Gaffney, South Carolina, 29340
GSK Investigational Site
Gig Harbor, Washington, 98335
GSK Investigational Site
Glendale, Arizona, 85306
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Hershey, Pennsylvania, 17033
GSK Investigational Site
High Point, North Carolina, 27262
GSK Investigational Site
Houston, Texas, 77074
GSK Investigational Site
Indianapolis, Indiana, 46208
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Ithaca, New York, 14850
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Jefferson City, Missouri, 65101
GSK Investigational Site
Johnson City, Tennessee, 37601
GSK Investigational Site
Kingsport, Tennessee, 37660
GSK Investigational Site
Kirkland, Washington, 98034
GSK Investigational Site
La Crosse, Wisconsin, 54601
GSK Investigational Site
Lafayette, Louisiana, 70503
GSK Investigational Site
Lake Oswego, Oregon, 97035
GSK Investigational Site
Larchmont, New York, 10538
GSK Investigational Site
Lynchburg, Virginia, 24501
GSK Investigational Site
Madisonville, Kentucky, 42431
GSK Investigational Site
McKeesport, Pennsylvania, 15132
GSK Investigational Site
Milwaukee, Wisconsin, 53209
GSK Investigational Site
Minneapolis, Minnesota, 55407
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Mogadore, Ohio, 44260
GSK Investigational Site
Morgantown, West Virginia, 26505
GSK Investigational Site
New Braunfels, Texas, 78130
GSK Investigational Site
New Orleans, Louisiana, 70112
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
Newport News, Virginia, 23606
GSK Investigational Site
Olathe, Kansas, 66061
GSK Investigational Site
Omaha, Nebraska, 68124
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Pensacola, Florida, 32504
GSK Investigational Site
Phoenix, Arizona, 85013
GSK Investigational Site
Pittsburgh, Pennsylvania, 15025
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243
GSK Investigational Site
Providence, Rhode Island, 2909
GSK Investigational Site
Raleigh, North Carolina, 27612
GSK Investigational Site
Richmond, Virginia, 23225
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
Sacramento, California, 95825
GSK Investigational Site
Saint Charles, Missouri, 63301
GSK Investigational Site
Saint Joseph, Michigan, 49085
GSK Investigational Site
San Antonio, Texas, 78217
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
San Marcos, Texas, 78666
GSK Investigational Site
Sarasota, Florida, 34239
GSK Investigational Site
Shreveport, Louisiana, 71103
GSK Investigational Site
Simpsonville, South Carolina, 29681
GSK Investigational Site
South Bend, Indiana, 46617
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
Springfield, Illinois, 62702
GSK Investigational Site
St Louis, Missouri, 63110
GSK Investigational Site
Stamford, Connecticut, 06902
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Tamarac, Florida, 33321
GSK Investigational Site
Vista, California, 92084
GSK Investigational Site
Winston-Salem, North Carolina, 27157
GSK Investigational Site
Woodstock, Georgia, 30189

Other trials in United States

Canada15 sites

GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, A0G 1G0
GSK Investigational Site
Bonaventure, Quebec, G0C 1E0
GSK Investigational Site
Chandler, Quebec, G0C 1K0
GSK Investigational Site
Charlesbourg, Quebec, G1G 4A2
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8
GSK Investigational Site
Grimsby, Ontario, L3M 1P3
GSK Investigational Site
Holyrood, Newfoundland and Labrador, A0A 2R0
GSK Investigational Site
London, Ontario, N6C 4Y7
GSK Investigational Site
Saint John, New Brunswick, E2M 3W5
GSK Investigational Site
Saint-Léonard, Quebec, H1S 3A9
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1
GSK Investigational Site
Thunder Bay, Ontario, P7A 4V7
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1
GSK Investigational Site
Vancouver, British Columbia, V5Z 3J5
GSK Investigational Site
Winnipeg, Manitoba, R2K 3S8

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol Diskus Combination Product 250/50mcg BID With Salmeterol Diskus 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease

This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by FDA for use in patients with COPD.

Read the detailed description

A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 250/50mcg BID with Salmeterol DISKUS 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Fluticasone Propionate/Salmeterol Combination Product, Salmeterol
Keywords: Breathing, Exacerbation, Chronic Obstructive Pulmonary Disease
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration

What participants receive

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

Fluticasone Propionate/Salmeterol Combination ProductDrug
SalmeterolDrug
Also called Fluticasone Propionate/Salmeterol Combination Product

What is being measured

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

Rate of moderate/severe exacerbations over a 52 week treatment period

Secondary outcomes (1)

The time until the first moderate/severe exacerbation; the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year

Timeline

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

Dec 2004Jun 2007

First posted23 Jun 2005 (estimated)
Study startDec 2004
Primary completionJun 2007
Study completionJun 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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
Enrolment: 797 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00115492
Sponsor's protocol ID: SCO100250
Status last verified: Jan 2017
First submitted: 22 Jun 2005
Last updated: 20 Jan 2017
Results posted: No
Data monitoring committee: No
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

Disantostefano RL, Li H, Rubin DB, Stempel DA. Which patients with chronic obstructive pulmonary disease benefit from the addition of an inhaled corticosteroid to their bronchodilator? A cluster analysis. BMJ Open. 2013 Apr 22;3(4):e001838. doi: 10.1136/bmjopen-2012-001838. Print 2013.
PubMed 23613569

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

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol Diskus Combination Product 250/50mcg BID With Salmeterol Diskus 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT00115492
Acronym / sponsor ID: SCO100250
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Breathing, Exacerbation, Chronic Obstructive Pulmonary Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 797 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Dec 2004
Primary completion: Jun 2007 (actual)
Study completion: Jun 2007 (actual)
First posted: 23 Jun 2005 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

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

Key inclusion criteria (4 listed)

Diagnosis of COPD.
Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
History of at least 1 COPD exacerbation in the 12 months prior to screening.
Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.

Key exclusion criteria (6 listed)

Diagnosis of asthma.
Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
Lung resection surgery within 1 year of screening.
Abnormal and clinically significant ECG findings at screening.

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
Fluticasone Propionate/Salmeterol Combination Product	Drug	–
SalmeterolAlso: Fluticasone Propionate/Salmeterol Combination Product	Drug	–

Primary outcome

Rate of moderate/severe exacerbations over a 52 week treatment period

1 secondary outcome

The time until the first moderate/severe exacerbation; the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
Derived from this study: PubMed 23613569Disantostefano RL, Li H, Rubin DB, Stempel DA. Which patients with chronic obstructive pulmonary disease benefit from the addition of an inhaled corticosteroid to their bronchodilator? A cluster analysis. BMJ Open. 2013 Apr 22;3(4):e001838. doi: 10.1136/bmjopen-2012-001838. Print 2013.
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.

Related trials for Pulmonary Disease, Chronic Obstructive

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders

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

110 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluticasone Propionate/Salmeterol Combination Product and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 110 sites in 2 countries.

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 6 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 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in United States, Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rate of moderate/severe exacerbations over a 52 week treatment period. 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 NCT00115492, 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 20 Jan 2017.