COPDNCT00559312
The Effect of Fluticasone/Salmeterol Combination on Exertional Breathlessness in Patients With Mild COPD
A study testing fluticasone/salmeterol combination in people with COPD, run by Queen's University at 1 site in Canada.
Trial summary
Even patients with milder COPD can have significant physiological abnormalities which become more pronounced during exercise, leading to intolerable breathing discomfort (dyspnea). Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- COPD
- What is being tested?
- fluticasone/salmeterol combination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2007to Apr 2010
- Phase
- Interventional
- 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 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable mild COPD,
- FEV1/FVC<0.7 and FEV1>60% predicted,
- Activity-related dyspnea (i.e., Baseline Dyspnea Index focal score <9, MRC dyspnea scale >2),
- Cigarette smoking history ≥20 pack-years.
Who cannot join
- Presence of a significant disease other than COPD that could contribute to dyspnea and exercise limitation,
- Important contraindications to clinical exercise testing,
- Use of daytime oxygen,
- History of Asthma.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Respiratory Investigation Unit at Kingston General Hospital
Kingston, Ontario, K7L 2V7
About this study
Official title: A 6-week Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Fluticasone 250μg/Salmeterol 50μg Combination (FSC 250/50) on Exertional Dyspnea in Patients With Symptomatic Mild COPD
Even patients with milder COPD can have significant physiological abnormalities which become more pronounced during exercise, leading to intolerable breathing discomfort (dyspnea). While there is a compelling physiological rationale for the efficacy of inhaled corticosteroid/long-acting bronchodilator combination therapy [i.e., fluticasone 250μg/salmeterol 50μg (FSC250/50)] in moderate to severe COPD, little information is available on the potential impact of this therapy in milder symptomatic disease. This study will be the first to explore mechanisms of dyspnea and activity limitation in milder COPD and will determine if there is a sound physiological rationale for the use of FSC as therapy for this subpopulation.
- Conditions
- COPD
- Being tested
- fluticasone/salmeterol combination, placebo
- Keywords
- mild COPD, dyspnea, exercise, combination therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone/salmeterol combinationDrug
Also called Advair 250/50
Diskus inhaler, fluticasone 250μg/salmeterol 50μg, twice daily, 6-week duration
placeboDrug
Placebo Diskus inhaler, twice daily, 6-week duration
| Study group | Role | What they receive |
|---|---|---|
| FSC 250/50 | Experimental | fluticasone 250μg/salmeterol 50μg combination Receives: Drug: fluticasone/salmeterol combination |
| Placebo | Placebo comparator | matched placebo inhaler Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea intensity (Borg rating at a standardized time during exercise)
Measured: 6 weeks
Secondary outcomes (3)
Exercise endurance time
Measured: 6 weeks
Measurements of small airway function
Measured: 6 weeks
Exercise measurements of ventilation, breathing pattern, operating lung volumes and respiratory mechanics
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Dr. Denis O'Donnell, Queen's University
- Investigators
- Denis E O'Donnell, MD, FRCPC, Principal investigator, Queen's University and Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559312
- Sponsor's protocol ID
- SCO110755
- Status last verified
- Dec 2012
- First submitted
- 14 Nov 2007
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-week Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Fluticasone 250μg/Salmeterol 50μg Combination (FSC 250/50) on Exertional Dyspnea in Patients With Symptomatic Mild COPD
- ClinicalTrials.gov ID
- NCT00559312
- Acronym / sponsor ID
- SCO110755
- Conditions
- COPD
- Keywords
- mild COPD, dyspnea, exercise, combination therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Dec 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 16 Nov 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.
Even patients with milder COPD can have significant physiological abnormalities which become more pronounced during exercise, leading to intolerable breathing discomfort (dyspnea). While there is a compelling physiological rationale for the efficacy of inhaled corticosteroid/long-acting bronchodilator combination therapy [i.e., fluticasone 250μg/salmeterol 50μg (FSC250/50)] in moderate to severe COPD, little information is available on the potential impact of this therapy in milder symptomatic disease. This study will be the first to explore mechanisms of dyspnea and activity limitation in milder COPD and will determine if there is a sound physiological rationale for the use of FSC as therapy for this subpopulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FSC 250/50 | Experimental | Drug: fluticasone/salmeterol combinationfluticasone 250μg/salmeterol 50μg combination |
| Placebo | Placebo comparator | Drug: placebomatched placebo inhaler |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable mild COPD,
- FEV1/FVC<0.7 and FEV1>60% predicted,
- Activity-related dyspnea (i.e., Baseline Dyspnea Index focal score <9, MRC dyspnea scale >2),
- Cigarette smoking history ≥20 pack-years.
Key exclusion criteria (4 listed)
- Presence of a significant disease other than COPD that could contribute to dyspnea and exercise limitation,
- Important contraindications to clinical exercise testing,
- Use of daytime oxygen,
- History of Asthma.
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/salmeterol combinationAlso: Advair 250/50Diskus inhaler, fluticasone 250μg/salmeterol 50μg, twice daily, 6-week duration | Drug | FSC 250/50 |
| placeboPlacebo Diskus inhaler, twice daily, 6-week duration | Drug | Placebo |
Primary outcome
Dyspnea intensity (Borg rating at a standardized time during exercise)
Time frame: 6 weeks
3 secondary outcomes
Exercise endurance time
Time frame: 6 weeks
Measurements of small airway function
Time frame: 6 weeks
Exercise measurements of ventilation, breathing pattern, operating lung volumes and respiratory mechanics
Time frame: 6 weeks
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 17 Dec 2012.
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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.
Denis E O'Donnell, MD, FRCPC principal investigator
Queen's University and Kingston General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluticasone/salmeterol combination in people with COPD, run by Queen's University at 1 site in Canada.
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 4 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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Dyspnea intensity (Borg rating at a standardized time during exercise) (time frame: 6 weeks). 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 17 Dec 2012.