COPDPhase 1NCT00655993
Effect of Statin Therapy on C-reactive Protein Levels in Patients With Chronic Obstructive Lung Disease (COPD)
A Phase 1 study testing simvastatin in people with COPD and Inflammation, run by VA Loma Linda Health Care System at 1 site in United States.
Trial summary
Hypothesis for this pilot study is that simvastatin will lower the levels of CRP and ET-1 in COPD patients. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- COPD, Inflammation
- What is being tested?
- simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2014
- Phase
- Phase 1
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically optimized COPD patients
- Age 40-79 years.
- serum CRP levels >3mg/l
Who cannot join
- Current smoker
- COPD exacerbation in the last 2 months.
- Active hepatic or severe renal dysfunction.
- connective tissue disease, chronic inflammatory disease, malignancy, any acute illness, leukocytosis (>10,000 white blood cells) or thrombocytosis (>450,000 platelets).
- Recent h/o myocardial infarction, angina in the last 6 months.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Loma Linda Health Care System
Loma Linda, California, 92357
About this study
Official title: Effect of Statin Therapy on C-reactive Protein Levels in Patients With COPD
Hypothesis for this pilot study is that simvastatin will lower the levels of CRP and ET-1 in COPD patients.
Read the detailed description
Patients with chronic obstructive lung disease (COPD) have an ongoing systemic inflammation, which can be assessed by measuring C-reactive protein (CRP). CRP is found to be a strong and independent predictor of future COPD outcomes. Statins are a class of cholesterol lowering drugs that decrease mortality from cardiovascular disease and stroke. In addition, they have anti-inflammatory, anti-thrombotic and immunomodulatory properties. Statins lower C-reactive protein by the ability to reduce the production of interleukin (IL)-6, the cytokine that activates the acute phase CRP response.
Thus the rationale for this study is to evaluate effect of statins on the levels of CRP and ET-1 in COPD patients.
- Conditions
- COPD, Inflammation
- Being tested
- simvastatin
- Keywords
- COPD, Inflammation, CRP levels, simvastatin
- 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.
simvastatinDrug
40 mg po daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | placebo drug Receives: Drug: simvastatin |
| 2 | Active comparator | simvastatin Receives: Drug: simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum CRP levels
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionAug 2014
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Loma Linda Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, James D. Anholm, M.D., VA Loma Linda Health Care System
- Investigators
- Lennard Specht, M.D., Principal investigator, VA Loma Linda Health Care SystemHemal J. Parekh, M.D., Principal investigator, VA Loma LInda Healthcare SystemJames D. Anholm, M.D., Principal investigator, VA Loma Linda Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655993
- Sponsor's protocol ID
- 00746
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2008
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Statin Therapy on C-reactive Protein Levels in Patients With COPD
- ClinicalTrials.gov ID
- NCT00655993
- Acronym / sponsor ID
- 00746
- Conditions
- COPD, Inflammation
- Keywords
- COPD, Inflammation, CRP levels, simvastatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VA Loma Linda Health Care SystemUS federal agency
- Study start
- Apr 2008 (actual)
- Primary completion
- Mar 2009 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Apr 2008 (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.
Hypothesis for this pilot study is that simvastatin will lower the levels of CRP and ET-1 in COPD patients.
Detailed description
Patients with chronic obstructive lung disease (COPD) have an ongoing systemic inflammation, which can be assessed by measuring C-reactive protein (CRP). CRP is found to be a strong and independent predictor of future COPD outcomes. Statins are a class of cholesterol lowering drugs that decrease mortality from cardiovascular disease and stroke. In addition, they have anti-inflammatory, anti-thrombotic and immunomodulatory properties. Statins lower C-reactive protein by the ability to reduce the production of interleukin (IL)-6, the cytokine that activates the acute phase CRP response.
Thus the rationale for this study is to evaluate effect of statins on the levels of CRP and ET-1 in COPD patients.
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 |
|---|---|---|
| 1 | Placebo comparator | Drug: simvastatinplacebo drug |
| 2 | Active comparator | Drug: simvastatinsimvastatin |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medically optimized COPD patients
- Age 40-79 years.
- serum CRP levels >3mg/l
Key exclusion criteria (6 listed)
- Current smoker
- COPD exacerbation in the last 2 months.
- Active hepatic or severe renal dysfunction.
- connective tissue disease, chronic inflammatory disease, malignancy, any acute illness, leukocytosis (>10,000 white blood cells) or thrombocytosis (>450,000 platelets).
- Recent h/o myocardial infarction, angina in the last 6 months.
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 |
|---|---|---|
| simvastatin40 mg po daily | Drug | 1, 2 |
Primary outcome
serum CRP levels
Time frame: 9 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 26 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Lennard Specht, M.D. principal investigator
VA Loma Linda Health Care System
Hemal J. Parekh, M.D. principal investigator
VA Loma LInda Healthcare System
James D. Anholm, M.D. principal investigator
VA Loma Linda Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing simvastatin in people with COPD and Inflammation, run by VA Loma Linda Health Care System at 1 site 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 6 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 26 Apr 2023. 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 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
serum CRP levels (time frame: 9 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 26 Apr 2023.