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.
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
- 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
- Any uncontrolled disease, other than COPD,
that would have more effect on length of this hospital
the COPD exacerbation
- Are not part of another clinical
- 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
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
two groups of patients. One group will take a pill
that contains a drug called zileuton. The other group
will take a pill that looks exactly the same called
a placebo (like a sugar pill). Your chance of getting
is the same as your chance of getting the placebo.
Neither you, the doctors nor the study staff will know
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
will occur within 12 hours of your admission to the
hospital to find out whether you are eligible for the
about your medical history, medicines, and symptoms
will be obtained. A blood and urine sample will be
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
After that, follow-up visits will occur while
you are in the hospital (at 24 hours after the Enrollment
and then every other day including the day you are
discharged from the hospital). While you are in the
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
a member of the study staff will visit you in your
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
Additional information can also be found
at the following Website: