Pulmonary Disease, Chronic ObstructivePhase 3NCT00549146
Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease
A Phase 3 study testing fluticasone propionate/salmeterol 250/50 DISKUS combination product and fluticasone propionate DISKUS 500mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 17 sites in Netherlands.
Trial summary
Relatively little information is available about the effects of salmeterol/fluticasone combination and fluticasone alone in COPD patients with a partial reversible pulmonary obstruction. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- fluticasone propionate/salmeterol 250/50 DISKUS combination product and fluticasone propionate DISKUS 500mcg
- How many people
- 290 participants
- Where
- 17 sitesNetherlands
- Study dates
- Nov 2003to Apr 2006
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established history of chronic obstructive pulmonary disease (COPD).
- Lung function parameters: FEV1/FVC ratio < 70%, FEV1 between 80% and 30% predicted, a reversibility of airway obstruction of 12% of the initial value with a minimum of 200 mL.
- Signed and dated informed consent.
Who cannot join
- History of asthma or allergy.
- Unstable COPD in the 3 months before the study.
- Interference of non-pulmonary medication or diseases with COPD outcome parameters.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Netherlands17 sites
GSK Investigational Site
Alkmaar, 1815 JD
GSK Investigational Site
Almelo, 7609 PP
GSK Investigational Site
Amsterdam, 1034 CS
GSK Investigational Site
Amsterdam, 1058 NR
GSK Investigational Site
Amsterdam, 1091 AC
GSK Investigational Site
Drachten, 9202 NN
GSK Investigational Site
Haarlem, 2012 CE
GSK Investigational Site
Harderwijk, 3844 DG
GSK Investigational Site
Hengelo, 7555 DL
GSK Investigational Site
Hoorn, 1624 NP
GSK Investigational Site
Leeuwarden, 8934 AD
GSK Investigational Site
Meppel, 7943 KA
GSK Investigational Site
Nijmegen, 6532 SZ
GSK Investigational Site
Rotterdam, 3045 PM
GSK Investigational Site
Sneek, 8601 ZK
GSK Investigational Site
Utrecht, 2584 CX
GSK Investigational Site
Voerendaal, 6367 ED
About this study
Official title: Multi-centre, DB, R and Stratified Parallel Group Study to Compare the Efficacy and Safety of FP 500mcg Bid vs. SRT 50/250mcg Via Diskus in COPD Pts With Partial Reversible Obstruction
Relatively little information is available about the effects of salmeterol/fluticasone combination and fluticasone alone in COPD patients with a partial reversible pulmonary obstruction. The purpose of this study is to compare the effects of salmeterol/fluticasone combination with fluticasone alone delivered via Diskus/ACCUHALER inhaler in subjects with COPD on lung function over a 1 year period.
Read the detailed description
Multi-centre, double-blind, randomised and stratified parallel group study to compare the efficacy and safety of fluticasone propionate 500 mcg bd versus salmeterol/fluticasone combination 50/250 mcg bd both via Diskus inhaler during 1 year in Chronic Obstructive Pulmonary Disease(COPD) patients with a partially reversible obstruction.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- fluticasone propionate/salmeterol 250/50 DISKUS combination product, fluticasone propionate DISKUS 500mcg
- Keywords
- reversibility, COPD, lung function
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone propionate/salmeterol 250/50 DISKUS combination productDrug
fluticasone propionate DISKUS 500mcgDrug
Also called fluticasone propionate/salmeterol 250/50 DISKUS combination product
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted.
Secondary outcomes (1)
Reversibility of lung function with salbutamol and on Forced Vital capacity (FVC), TLC, FRC, FVC, Inspiration capacity(IC), Forced Inspiratory Volume in 1 second (FIV1) and Maximum mid-Expiratory Flow (MEF50).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startNov 2003
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 290 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
- NCT00549146
- Sponsor's protocol ID
- SCO40055
- Status last verified
- Jan 2017
- First submitted
- 24 Oct 2007
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
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
- Multi-centre, DB, R and Stratified Parallel Group Study to Compare the Efficacy and Safety of FP 500mcg Bid vs. SRT 50/250mcg Via Diskus in COPD Pts With Partial Reversible Obstruction
- ClinicalTrials.gov ID
- NCT00549146
- Acronym / sponsor ID
- SCO40055
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- reversibility, COPD, lung function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2003 (actual)
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 25 Oct 2007 (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.
Relatively little information is available about the effects of salmeterol/fluticasone combination and fluticasone alone in COPD patients with a partial reversible pulmonary obstruction. The purpose of this study is to compare the effects of salmeterol/fluticasone combination with fluticasone alone delivered via Diskus/ACCUHALER inhaler in subjects with COPD on lung function over a 1 year period.
Detailed description
Multi-centre, double-blind, randomised and stratified parallel group study to compare the efficacy and safety of fluticasone propionate 500 mcg bd versus salmeterol/fluticasone combination 50/250 mcg bd both via Diskus inhaler during 1 year in Chronic Obstructive Pulmonary Disease(COPD) patients with a partially reversible obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established history of chronic obstructive pulmonary disease (COPD).
- Lung function parameters: FEV1/FVC ratio < 70%, FEV1 between 80% and 30% predicted, a reversibility of airway obstruction of 12% of the initial value with a minimum of 200 mL.
- Signed and dated informed consent.
Key exclusion criteria (3 listed)
- History of asthma or allergy.
- Unstable COPD in the 3 months before the study.
- Interference of non-pulmonary medication or diseases with COPD outcome parameters.
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 250/50 DISKUS combination product | Drug | – |
| fluticasone propionate DISKUS 500mcgAlso: fluticasone propionate/salmeterol 250/50 DISKUS combination product | Drug | – |
Primary outcome
Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted.
1 secondary outcome
Reversibility of lung function with salbutamol and on Forced Vital capacity (FVC), TLC, FRC, FVC, Inspiration capacity(IC), Forced Inspiratory Volume in 1 second (FIV1) and Maximum mid-Expiratory Flow (MEF50).
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.
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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
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fluticasone propionate/salmeterol 250/50 DISKUS combination product and fluticasone propionate DISKUS 500mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 17 sites in Netherlands.
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 3 inclusion and 3 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 17 sites in Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.