Pulmonary Disease, Chronic ObstructivePhase 4NCT00346749
ADVAIR DISKUS® (Fluticasone Propionate/Salmeterol) Inhaler Versus SEREVENT DISKUS® (Salmeterol) Inhlaer On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease. ADVAIR DISKUS® and SEREVENT DISKUS® Inhalers 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 11 sites in United States.
Trial summary
This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. 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
- 180 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2006to Jul 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.
- Pre-bronchodilator FEV1 less than or equal to 70.0% and greater than or equal to 0.70L
- Ex-Smokers with at least a 10 pack-year history.
Who cannot join
- Current of secondary diagnosis of asthma or current diagnosis of atopy.
- Other respiratory disorders other than COPD.
- Other inflammatory diseases.
- Abnormal and clinically significant chest x-ray or ECG.
- Lung resection surgery within past 1 year.
- History of cancer not in remission within past 2 years.
- Serious, uncontrolled disease.
- Pregnancy or planning to become pregnant during the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
GSK Investigational Site
Birmingham, Alabama, 35294
GSK Investigational Site
Decatur, Georgia, 30030
GSK Investigational Site
Durham, North Carolina, 27704
GSK Investigational Site
Fort Collins, Colorado, 80528
GSK Investigational Site
Gainesville, Florida, 32610
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Los Angeles, California, 90095-1752
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
GSK Investigational Site
San Diego, California, 92103
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, 12-Week Study to Evaluate the Anti-Inflammatory Effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg BID Compared With Salmeterol DISKUS 50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing tests and will complete diary cards during the study. All study medicines and examinations will be given at no cost to the study subjects. Both medicines used in this study have been approved by the US FDA.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Salmeterol, Fluticasone Propionate/Salmeterol Combination Product
- Keywords
- Inflammation, FEV1, Sputum
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation
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.
Percent of sputum neutrophils
Secondary outcomes (1)
Inflammation endpoints: Cell counts in sputum, cell counts and protein markers in BAL, protein markers in blood Clinical endpoints: FEV1 Airway conductance and airway resistance Functional residual capacity Shortness of breath symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2006 (estimated)
- Study startDec 2006
- Primary completionJul 2007
- Study completionJul 2007
Why it stopped: The study was terminated due to difficulties with finding sites and subjects willing to participate.
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
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants
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
- NCT00346749
- Sponsor's protocol ID
- ADC105931
- Status last verified
- Oct 2016
- First submitted
- 28 Jun 2006
- 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
This study has not been published in the scientific literature.
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, 12-Week Study to Evaluate the Anti-Inflammatory Effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg BID Compared With Salmeterol DISKUS 50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00346749
- Acronym / sponsor ID
- ADC105931
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Inflammation, FEV1, Sputum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to difficulties with finding sites and subjects willing to participate.
- Enrolment
- 180 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 30 Jun 2006 (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). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing tests and will complete diary cards during the study. All study medicines and examinations will be given at no cost to the study subjects. Both medicines used in this study have been approved by the US FDA.
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 (3 listed)
- Diagnosis of COPD.
- Pre-bronchodilator FEV1 less than or equal to 70.0% and greater than or equal to 0.70L
- Ex-Smokers with at least a 10 pack-year history.
Key exclusion criteria (8 listed)
- Current of secondary diagnosis of asthma or current diagnosis of atopy.
- Other respiratory disorders other than COPD.
- Other inflammatory diseases.
- Abnormal and clinically significant chest x-ray or ECG.
- Lung resection surgery within past 1 year.
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
Percent of sputum neutrophils
1 secondary outcome
Inflammation endpoints: Cell counts in sputum, cell counts and protein markers in BAL, protein markers in blood Clinical endpoints: FEV1 Airway conductance and airway resistance Functional residual capacity Shortness of breath symptoms
Results and safety
The study was stopped early (reason given: The study was terminated due to difficulties with finding sites and subjects willing to participate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- 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
11 sites in 1 country: 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 11 sites in United States.
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 8 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: stopped early, 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 11 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?
The study was stopped early (reason given: The study was terminated due to difficulties with finding sites and subjects willing to participate.). Results are not available in the source record.
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 of sputum neutrophils. 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 NCT00346749, 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 28 Oct 2016.