Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT00387036
Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)
A Phase 2 study testing Fluticasone in people with Chronic Obstructive Pulmonary Disease (COPD), run by Merck Sharp & Dohme LLC.
Trial summary
To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Fluticasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 40 years and older
- Clinical diagnosis of COPD for greater than one year
- History of cigarette smoking
Who cannot join
- Other lung diseases (not including COPD), such as asthma
- A condition that could interfere with your ability to perform exercise tests
About this study
Official title: A Multicenter, Double-Blind Placebo-Controlled Crossover Study to Investigate the Effects of an Inhaled Corticosteroid on Cardiopulmonary Exercise Parameters in Patients With Chronic Obstructive Pulmonary Disease
To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).
- Being tested
- Fluticasone, Comparator: Placebo
- 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.
FluticasoneDrug
fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.
Comparator: PlaceboDrug
Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Arm 1: drug, crossing over to Pbo comparator Receives: Drug: Fluticasone |
| 2 | Other | Arm 2: Pbo comparator, crossing over to drug Receives: Drug: Fluticasone; Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Dyspnea Score at Isotime During Exercise
Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.
Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 [Best] - 10 [Worst] ).
Measured: 2 Weeks
Secondary outcomes (1)
Exercise Endurance Time
Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startDec 2006
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: Termininated for business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387036
- Sponsor's protocol ID
- 0000-036
- Other IDs
- 036, 2006_039
- Status last verified
- Dec 2015
- First submitted
- 5 Oct 2006
- Last updated
- 21 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Guenette JA, Raghavan N, Harris-McAllister V, Preston ME, Webb KA, O'Donnell DE. Effect of adjunct fluticasone propionate on airway physiology during rest and exercise in COPD. Respir Med. 2011 Dec;105(12):1836-45. doi: 10.1016/j.rmed.2011.08.021. Epub 2011 Sep 13.
PubMed 21917440
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind Placebo-Controlled Crossover Study to Investigate the Effects of an Inhaled Corticosteroid on Cardiopulmonary Exercise Parameters in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00387036
- Acronym / sponsor ID
- 0000-036
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termininated for business reasons
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 12 Oct 2006 (estimated)
- Results
- Posted 26 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: FluticasoneArm 1: drug, crossing over to Pbo comparator |
| 2 | Other | Drug: Fluticasone, Drug: Comparator: PlaceboArm 2: Pbo comparator, crossing over to drug |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 years and older
- Clinical diagnosis of COPD for greater than one year
- History of cigarette smoking
Key exclusion criteria (2 listed)
- Other lung diseases (not including COPD), such as asthma
- A condition that could interfere with your ability to perform exercise tests
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 |
|---|---|---|
| Fluticasonefluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment. | Drug | 1, 2 |
| Comparator: PlaceboPlacebo /inhalation, 2 inhalations bid. 14 Days of treatment. | Drug | 2 |
Primary outcome
Standardized Dyspnea Score at Isotime During Exercise
Time frame: 2 Weeks
Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period. Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 [Best] - 10 [Worst] ).
1 secondary outcome
Exercise Endurance Time
Time frame: 2 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21917440Guenette JA, Raghavan N, Harris-McAllister V, Preston ME, Webb KA, O'Donnell DE. Effect of adjunct fluticasone propionate on airway physiology during rest and exercise in COPD. Respir Med. 2011 Dec;105(12):1836-45. doi: 10.1016/j.rmed.2011.08.021. Epub 2011 Sep 13.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluticasone in people with Chronic Obstructive Pulmonary Disease (COPD), run by Merck Sharp & Dohme LLC.
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 2 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 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Standardized Dyspnea Score at Isotime During Exercise (time frame: 2 Weeks). 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 NCT00387036, 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 21 Jan 2016.