Pulmonary Disease, Chronic ObstructivePhase 4NCT00144911
ADVAIR® DISKUS® Inhaler (Fluticasone Propionate/Salmeterol) Versus SEREVENT® DISKUS® Inhaler (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations. ADVAIR® DISKUS® Inhaler and SEREVENT® DISKUS® Inhaler Are Trademarks of the GSK Group of Companies.
A Phase 4 study testing Salmeterol and Fluticasone Propionate/Salmeterol Combination Product in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 97 sites in 2 countries.
Trial summary
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. 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 and Fluticasone Propionate/Salmeterol Combination Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- 97 sitesin 2 countries
- Study dates
- Oct 2004to Dec 2006
- 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 (chronic obstructive pulmonary disease).
- Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
- History of a 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
- Current 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
97 sites in 2 countries.
97 sites in 2 countries
United States85 sites
GSK Investigational Site
Abingdon, Virginia, 24210
GSK Investigational Site
Albuquerque, New Mexico, 87108
GSK Investigational Site
Auburn, Maine, 04210
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Birmingham, Alabama, 35294-0012
GSK Investigational Site
Boston, Massachusetts, 02118
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Champaign, Illinois, 61821
GSK Investigational Site
Charleston, South Carolina, 29406-7108
GSK Investigational Site
Charlottesville, Virginia, 22908
GSK Investigational Site
Cherry Hill, New Jersey, 08003
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Cincinnati, Ohio, 45219
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Cleveland, Ohio, 44109
GSK Investigational Site
Coeur d'Alene, Idaho, 83814
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Columbus, Ohio, 43215
GSK Investigational Site
Corona, California, 92879
GSK Investigational Site
Corsicana, Texas, 75110
GSK Investigational Site
Cumberland, Rhode Island, 02864
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Denver, Colorado, 80204
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
Des Moines, Iowa, 50309
GSK Investigational Site
Elizabeth City, North Carolina, 27909
GSK Investigational Site
Englewood, Colorado, 80113
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Evansville, Indiana, 47710
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Gig Harbor, Washington, 98335
GSK Investigational Site
Glendale, Arizona, 85306
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Jacksonville, Florida, 32205
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Johnson City, Tennessee, 37601
GSK Investigational Site
Kalamazoo, Michigan, 49009
GSK Investigational Site
Kansas City, Missouri, 64108
GSK Investigational Site
Lafayette, Louisiana, 70503
GSK Investigational Site
Larchmont, New York, 10538
GSK Investigational Site
Largo, Florida, 33770
GSK Investigational Site
Lewistown, New York, 14092
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Los Angeles, California, 90095-1752
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Minneapolis, Minnesota, 55407
GSK Investigational Site
Morgantown, West Virginia, 26505
GSK Investigational Site
Newport News, Virginia, 23606
GSK Investigational Site
North Miami Beach, Florida, 33179
GSK Investigational Site
Omaha, Nebraska, 68105
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Palmdale, California, 93551
GSK Investigational Site
Paramount, California, 90723
GSK Investigational Site
Pensacola, Florida, 32504
GSK Investigational Site
Peoria, Illinois, 61602
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
GSK Investigational Site
Phoenix, Arizona, 85013
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243
GSK Investigational Site
Portland, Oregon, 97213
GSK Investigational Site
Providence, Rhode Island, 02906
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Rancho Mirage, California, 92270
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
Sacramento, California, 95825-5480
GSK Investigational Site
Saint Charles, Missouri, 63301
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
Scottsdale, Arizona, 85258
GSK Investigational Site
Sepulveda, California, 91343
GSK Investigational Site
Simpsonville, South Carolina, 29681
GSK Investigational Site
Slidell, Louisiana, 70458
GSK Investigational Site
South Bend, Indiana, 46617
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Spokane, Washington, 99202
GSK Investigational Site
St Louis, Missouri, 63122
GSK Investigational Site
Statesville, North Carolina, 28625
GSK Investigational Site
Stockton, California, 95207
GSK Investigational Site
Summit, New Jersey, 07091
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
Toledo, Ohio, 43614-5809
GSK Investigational Site
Tulsa, Oklahoma, 74135
GSK Investigational Site
Wheat Ridge, Colorado, 80033
GSK Investigational Site
Worcester, Massachusetts, 01608
Canada12 sites
GSK Investigational Site
Calgary, Alberta, T2N 4N1
GSK Investigational Site
Cowansville, Quebec, J2K 2X9
GSK Investigational Site
Grimsby, Ontario, L3M 1P3
GSK Investigational Site
La Malbaie, Quebec, G5A 1W7
GSK Investigational Site
Montreal, Quebec, H3T 1Y6
GSK Investigational Site
Saint-Léonard, Quebec, H1S 3A9
GSK Investigational Site
Sainte Jerome, Quebec, J7Z 5T3
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5
GSK Investigational Site
Sherbrooke, Quebec, J1H 4J6
GSK Investigational Site
Sorel-Tracy, Quebec, J3P 1N5
GSK Investigational Site
Toronto, Ontario, M5G 1N8
GSK Investigational Site
Winnipeg, Manitoba, R2K 3S8
About this study
Official title: A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol DISKUS® Inhaler Combination Product 250/50mcg Twice Daily With Salmeterol DISKUS® Inhaler 50mcg Twice Daily on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
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 the 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® inhaler Combination Product 250/50mcg twice daily (BID) with Salmeterol DISKUS® inhaler 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
- Salmeterol, Fluticasone Propionate/Salmeterol Combination Product
- Keywords
- exacerbations, breathing, 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.
SalmeterolDrug
Fluticasone Propionate/Salmeterol Combination ProductDrug
Also called Salmeterol
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Salmeterol; Drug: 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.
- First posted5 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144911
- Sponsor's protocol ID
- SCO40043
- Status last verified
- Oct 2016
- First submitted
- 1 Sep 2005
- Last updated
- 28 Oct 2016
- 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
Ferguson GT, Anzueto A, Fei R, Emmett A, Knobil K, Kalberg C. Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations. Respir Med. 2008 Aug;102(8):1099-108. doi: 10.1016/j.rmed.2008.04.019. Epub 2008 Jul 9.
PubMed 18614347Disantostefano 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. 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® Inhaler Combination Product 250/50mcg Twice Daily With Salmeterol DISKUS® Inhaler 50mcg Twice Daily on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00144911
- Acronym / sponsor ID
- SCO40043
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- exacerbations, breathing, chronic obstructive pulmonary disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 740 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 5 Sep 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.
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 the FDA for use in patients with COPD.
Detailed description
A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS® inhaler Combination Product 250/50mcg twice daily (BID) with Salmeterol DISKUS® inhaler 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Salmeterol, Drug: Fluticasone Propionate/Salmeterol Combination Product |
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 (chronic obstructive pulmonary disease).
- Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
- History of a 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)
- Current 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 |
|---|---|---|
| Salmeterol | Drug | Arm 1 |
| Fluticasone Propionate/Salmeterol Combination ProductAlso: Salmeterol | Drug | Arm 1 |
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 28 Oct 2016.
- Background: PubMed 18614347Ferguson GT, Anzueto A, Fei R, Emmett A, Knobil K, Kalberg C. Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations. Respir Med. 2008 Aug;102(8):1099-108. doi: 10.1016/j.rmed.2008.04.019. Epub 2008 Jul 9.
- 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.
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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
97 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 Salmeterol and Fluticasone Propionate/Salmeterol Combination Product in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 97 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 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 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 NCT00144911, which also lists 2 linked publications.
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 28 Oct 2016.