Study Completed

Study Title: Anti-Leukotriene Therapy for COPD Exacerbations

Chronic obstructive pulmonary disease (COPD) is a disease of the lungs that affects many smokers. Some patients with COPD develop one or more “exacerbations” or “flare-ups”, a temporary worsening of lung symptoms that may require admission to the hospital and could be life-threatening. The purpose of this study is to find out whether taking a medicine that reduces inflammation will help one to recover faster from a COPD exacerbation and shorten the time in the hospital.

What is zileuton?
Zileuton is a medication that is usually given to treat asthma. Zileuton works by blocking the formation of substances that cause inflammation, fluid retention, and constriction in the lungs. While this drug has been approved for asthma, it does not have current approval for use in COPD.

Who is eligible to participate?

  • Male and female patients, at least 45 years old
  • Admission to a hospital for an acute exacerbation of COPD
  • Either currently smoke or previously smoked
  • Do not have an allergy to zileuton
  • Do not currently take the medication theophylline
  • Do not have “lobar” or more widespread pneumonia, pulmonary edema (fluid in the lungs), asthma or interstitial lung disease
  • Any uncontrolled disease, other than COPD, that would have more effect on length of this hospital stay than the COPD exacerbation
  • Are not part of another clinical study
  • Do not have a history of liver disease

How many people will participate in the study and for how long?
520 patients will be enrolled across the country. Study participation lasts for 30 days.

How does the study work?
If you agree to participate in the study and your medical condition matches what we are looking for, you will be assigned at random (like flipping a coin) into one of two groups of patients. One group will take a pill that contains a drug called zileuton. The other group of patients will take a pill that looks exactly the same called a placebo (like a sugar pill). Your chance of getting zileuton is the same as your chance of getting the placebo. Neither you, the doctors nor the study staff will know which pill you are taking until the end of the study, although it will be possible to find out quickly in an emergency.

You will take the medicine (600 milligrams of zileuton) or the placebo four times a day for 14 days.
You will have several visits with study staff over a period of 30 days. The Enrollment visit (the first visit) will occur within 12 hours of your admission to the hospital to find out whether you are eligible for the study. Information about your medical history, medicines, and symptoms will be obtained. A blood and urine sample will be collected, and a simple breathing test (also known as a spirometry test to test how well your lungs are working) will be performed. Education about COPD will be provided to you.

After that, follow-up visits will occur while you are in the hospital (at 24 hours after the Enrollment visit and then every other day including the day you are discharged from the hospital). While you are in the hospital, breathing tests, urine collection, physical exams, and questions about your symptoms will be repeated.

On the 7th day following the Enrollment visit, you will be contacted by telephone. If you are still in the hospital, a member of the study staff will visit you in your room.

Finally, you will have two follow-up visits in your study doctor’s office at 14 days and 30 days after starting the study. The study visits will include a simple breathing test, a physical exam, questions about your health and symptoms, and a review for any possible undesirable study drug effects.

Additional information can also be found at the following Website:

http://www.clinicaltrials.gov/ct/show/NCT00493974?order=1

ClinicalTrials.gov Identifier: NCT00493974