Simvastatin Therapy for Moderate and Severe COPD (NCT01061671) | Clinical Trial Compass
TerminatedPhase 3
Simvastatin Therapy for Moderate and Severe COPD
Stopped: Futility
United States, Canada885 participantsStarted 2010-03
Plain-language summary
To determine the effect of daily administration of 40 mgms simvastatin taken for at least 12 months (range 12-36 months) on the frequency of exacerbations of chronic obstructive lung disease (COPD) in patients with moderate to severe COPD who are prone to exacerbations and do not have other indications for statin treatment.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female subjects, 40-80 years of age.
. Clinical diagnosis of at least moderate COPD as defined by the GOLD criteria:
. Postbronchodilator FEV1(forced expiratory volume at one second)/FVC(forced vital capacity) \< 70%,
. Postbronchodilator FEV1 (forced expiratory volume at one second) \< 80% predicted, with or without chronic symptoms (i.e., cough, sputum production).
. Cigarette consumption of 10 pack-years or more. Patients may or may not be active smokers.
. Must meet one or more of the following 4 conditions
. Be using supplemental oxygenate
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Receiving a course of systemic corticosteroids and/or antibiotics for respiratory problems in the past year,
Exclusion criteria
. Patients who:
. are on statin drugs.
. should be on statins based on established risk stratification using the ATP-III (Adult Treatment Panel) to determine 10 year risk.
. Documented history of active coronary heart disease, such as unstable angina, prior myocardial infarction, stroke, symptomatic peripheral vascular or carotid artery disease, or congestive heart failure within the past 3 months.
. A diagnosis of asthma.
. The presence of a diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy \< 3 years.
. Special patient groups: prisoners, pregnant women, institutionalized patients
. Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (hormone-based oral or barrier contraceptive) for the duration of the study.