STATCOPE - STATins in COPD Exacerbations

HAVE YOU HAD COPD FLARE-UPS?

TAKING A STATIN PILL ONCE-A-DAY MAY HELP.

The National Heart Lung Blood Institute (NHLBI) COPD Clinical Research Network (CCRN) and its nationwide network of clinical sites are conducting a trial to find out if a statin—currently used to help patients reduce cholesterol and prevent heart disease—can help reduce flare-ups in patients with COPD.


What is COPD?
Chronic obstructive pulmonary disease (COPD) is a serious lung condition that makes it hard to breathe. In the early stages, smoke or other air pollutants damage the lungs, reducing their natural elasticity and causing inflammation. Over the years, these lung changes limit the amount of air that can go in and out of the lungs. Because of the lung damage and obstruction, many patients struggle to take a deep breath and can’t get enough air.


WHAT IS A COPD FLARE-UP?
Many patients with COPD have occasional bad periods—usually lasting hours, days, or
weeks—of worsening symptoms. These flare-ups of symptoms are called exacerbations.

The symptoms of an exacerbation include:

  • more coughing or wheezing
  • increased and thickened sputum
    (mucus or phlegm)
  • intensified shortness of breath
  • fever and respiratory infection

These exacerbations are not only extremely uncomfortable, but they can be life-threatening. Flare-ups often require a change in medication such as taking a corticosteroid pill, using oxygen therapy, or taking an antibiotic. In some cases, patients need to be hospitalized for a COPD exacerbation.


HOW WILL STATCOPE HELP DISCOVER NEW TREATMENT FOR FLARE -UPS?
Lung inflammation increases during COPD flare-ups. Statin medications are known to decrease inflammation throughout the body. Also, some research shows that people with COPD who were given statins for high cholesterol had fewer respiratory symptoms.

This trial is designed to determine if statins can reduce the number and severity of COPD exacerbations in patients who are at risk of these flare-ups.

STATCOPE is important because although statins are already used by millions of people with heart disease, they do have side effects. This trial will carefully weigh the benefits and risks of a once-a-day dose of statin in a three-year study of over 1,000 COPD patients.

STATCOPE will help doctors decide if this type of medication might help the millions of COPD patients who are prone to flare-ups.


WHO IS ELIGIBLE TO PARTICIPATE?
To be part of this trial you must:

  • Have moderate or severe COPD
  • Have a recent history of flare-ups or be currently using supplemental oxygen
  • Be 40 to 80 years of age
  • Be a current or ex-smoker
  • Not have active heart disease or high cholesterol
  • Not be taking statins
  • Not have diabetes


HOW DOES STATCOPE WORK?

Potential participants will be screened for eligibility by one of the clinical sites around the country. If you are eligible for the trial, you may receive study medication or a placebo (an inactive substance) and medical tests, including breathing and blood tests, at no cost during the trial. You will be asked to answer questions about your medical history and symptoms. You will be eligible for some compensation for the costs associated with your participation in the trial.

  • All participants will be randomly assigned to 1 of 2 groups:
    1) those who take a pill that contains simvastatin
    2) those who take a placebo pill (an inactive substance)
  • You will take your pill, once per day for 1 to 3 years.
  • You will be taught about the potential side effects of the study medication.
  • You will continue to use your usual COPD treatments.
  • You will need to come back to the clinic where you enrolled about 4 to 6 times per year for blood tests and exams.
  • You will need to answer a phone survey about 6 to 7 times per year.
  • If you have a flare-up, you will go to see your own doctor or hospital as usual and you will inform them that you are in the trial. You will call the clinical site later to tell them about the medical care that you received for treating the flare-up.


WHY SHOULD I CONSIDER PARTICIPATING IN STATCOPE?

  • You will receive tests and advice from lung experts.
  • You will get new ideas and support to deal with COPD.
  • You will help answer an important question about the value of statins in reducing the risk of COPD flare-ups.
  • You will gain a personal satisfaction knowing that your result could help others who have COPD.