Chronic Obstructive Pulmonary Disease (COPD)Phase 2RODEONCT00929734
Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Rosuvastatin in people with Chronic Obstructive Pulmonary Disease (COPD), run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The purpose of this study is to investigate whether rosuvastatin improves measures of endothelial function, decreases measures of inflammation, and improves pulmonary function in patients with stable chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2010to Jan 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable COPD patients of both genders with no COPD exacerbations less than three weeks prior to inclusion
- COPD stage I to IV after the GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease)
- Age between 40 and 80 years
Who cannot join
- Diagnosed lung disease other than COPD, except chronic asthmatic bronchitis and mild bronchiectasis without or few physical signs (diagnosed by high resolution CT)
- History of or active coronary artery disease (CAD), cerebrovascular or peripheral vascular disease
- History of or clinically significant congestive heart failure, valvular heart disease, clinically significant arrhythmias or conduction delays
- History of uncontrolled arterial hypertension (defined as blood pressure above180/110 mmHg with or without the use of antihypertensive medication)
- Body mass index >40kg/m2
- History of diabetes mellitus, measured fasting glucose > 11 mmol/L
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- History of Hypercholesterolemia, measured total cholesterol > 8 mmol/L
- Known poliomyelitis, motor neurone disease, cranial or temporal arteritis, stroke or myopathy
- Neutropenia, anemia (Hb < 8 g/100mL)
- History of chronic renal failure, serum creatinine > 176 micromol/L (2.0mg/dL)
- Creatine kinase > 3 times the upper limit of normal (ULN)
- Acute or chronic liver disease (serum transaminases > 3 times the ULN)
- Pregnancy (oral examination and blood test prior to inclusion)
- Active abuse of drugs or alcohol, poor compliance anticipated
- Statin use within the last 4 weeks prior to study start or previously clear indication for statin use
- Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another hydroxymethylglutaryl-Coenzyme A-reductase inhibitor incl. Rosuvastatin
- History of malignant disease of any kind within 5 years prior to inclusion.
- History of uncontrolled hypothyroidism
- Participation in another pharmaceutical or medical device clinical trial study less than 4 weeks prior inclusion.
- Use concomitant of medications that are known to interact with Crestor. This includes the following medications: Warfarin and other coumarin (vitamin K antagonist) anticoagulants, Cyclosporin, Gemfibrozil and Antacid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of ROsuvastatin Therapy on Peripheral Vasodilator Function, Inflammatory Markers and Pulmonary Function in Patients With StablE Chronic Obstructive Pulmonary Disease
The purpose of this study is to investigate whether rosuvastatin improves measures of endothelial function, decreases measures of inflammation, and improves pulmonary function in patients with stable chronic obstructive pulmonary disease.
- Being tested
- Rosuvastatin, Placebo
- Keywords
- Inflammation, Atherosclerosis, Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Hydroxymethylglutaryl-CoA Reductase Inhibitor
10mg tablets, once daily in three months
PlaceboDrug
1 tablet, once daily in three months
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | Not described Receives: Drug: Rosuvastatin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change in Reactive Hyperemia Index (RHI)
Endothelial function assessed with peripheral arterial tonometry, expressed as the reactive hyperemia index (RHI) as a marker for subclinical atherosclerosis and future cardiovascular risk assessment.
Measured: Baseline to 3 months
Secondary outcomes (3)
Relative Change in FEV1
Measured: Baseline to 3 months
Relative Change in High-sensitivity C-reactive Protein
Measured: Baseline to 3 months
Relative Change in Interleukin 6
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startMar 2010
- Primary completionJan 2014
- Study completionJan 2014
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.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Haukeland University Hospital
- Responsible party
- Principal investigator, Torbjorn Omland, University Hospital, Akershus
- Investigators
- Torbjørn Omland, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929734
- Sponsor's protocol ID
- 2009A2
- Acronym
- RODEO
- Status last verified
- Sep 2015
- First submitted
- 26 Jun 2009
- Last updated
- 8 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of ROsuvastatin Therapy on Peripheral Vasodilator Function, Inflammatory Markers and Pulmonary Function in Patients With StablE Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00929734
- Acronym / sponsor ID
- RODEO / 2009A2
- Keywords
- Inflammation, Atherosclerosis, Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- AstraZeneca, Haukeland University Hospital
- Study start
- Mar 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 29 Jun 2009 (estimated)
- Results
- Posted 8 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether rosuvastatin improves measures of endothelial function, decreases measures of inflammation, and improves pulmonary function in patients with stable chronic obstructive pulmonary disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable COPD patients of both genders with no COPD exacerbations less than three weeks prior to inclusion
- COPD stage I to IV after the GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease)
- Age between 40 and 80 years
Key exclusion criteria (20 listed)
- Diagnosed lung disease other than COPD, except chronic asthmatic bronchitis and mild bronchiectasis without or few physical signs (diagnosed by high resolution CT)
- History of or active coronary artery disease (CAD), cerebrovascular or peripheral vascular disease
- History of or clinically significant congestive heart failure, valvular heart disease, clinically significant arrhythmias or conduction delays
- History of uncontrolled arterial hypertension (defined as blood pressure above180/110 mmHg with or without the use of antihypertensive medication)
- Body mass index >40kg/m2
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 |
|---|---|---|
| RosuvastatinAlso: Hydroxymethylglutaryl-CoA Reductase Inhibitor10mg tablets, once daily in three months | Drug | Rosuvastatin |
| Placebo1 tablet, once daily in three months | Drug | Placebo |
Primary outcome
Relative Change in Reactive Hyperemia Index (RHI)
Time frame: Baseline to 3 months
Endothelial function assessed with peripheral arterial tonometry, expressed as the reactive hyperemia index (RHI) as a marker for subclinical atherosclerosis and future cardiovascular risk assessment.
3 secondary outcomes
Relative Change in FEV1
Time frame: Baseline to 3 months
Relative Change in High-sensitivity C-reactive Protein
Time frame: Baseline to 3 months
Relative Change in Interleukin 6
Time frame: Baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Torbjørn Omland, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rosuvastatin in people with Chronic Obstructive Pulmonary Disease (COPD), run by University Hospital, Akershus at 1 site in Norway.
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 20 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 8 Oct 2015. 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 Norway. 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.
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 8 Oct 2015). 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?
Relative Change in Reactive Hyperemia Index (RHI) (time frame: Baseline to 3 months). 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 8 Oct 2015.