you already have protection against the virus. By collecting specimens of nasal 
secretions, stool, and urine, we will also determine that you do not already have the 
natural type of adenovirus in your body. The specific genes for cystic fibrosis which you 
carry in your chromosomes will be determined from a blood sample. We will also 
measure the voltage that normally exists across the cells that line your nose. You will be 
evaluated with these tests when you enter the study. You will then be clinically evaluated 
at about ten days before you are given the altered virus. The wait from the time of 
enrollment into the study and administration of the altered virus will be at least three 
weeks, but could be significantly longer. Most of the tests will be repeated just before 
you are given the altered virus, and some will be repeated during the visits between 
enrollment into the study and administration of the virus. 
The virus, known as adenovirus 2, is a common virus that is found in human airways and 
can cause a "cold". The virus that you will receive has been altered so that it cannot 
reproduce normally. These changes limit its ability to cause disease, to grow, and to 
spread. The normal gene for the cystic fibrosis protein, CFTR, has been inserted into the 
virus. In the laboratory, it has been shown that this altered virus can enter the cells that 
form the lining of the human nose and deposit the normal gene, so that normal CFTR is 
produced by the cells. Studies with laboratory animals suggest that the altered virus does 
not cause disease or illness. They also indicate that the virus can carry a new gene into 
the cells of the airway. However, there is no guarantee that the virus will behave the 
same way in humans. 
Seven days before the virus is applied, you will be admitted to the hospital. On that day, 
we will numb the interior of your nose and give you a mild tranquilizer that will reduce 
anxiety and help you sit still. We will place a small tube through your nostril into each 
maxillary sinus. The tube will be left in place for seven days, during which time we will 
use it wash the sinuses and to instill antibiotics into the sinuses. This will be done three 
times a day. We will also give you antibiotics by vein to treat your lung disease and 
disease in the sinuses. 
On the eighth day after you are admitted, we will put a few drops of the altered virus into 
one of the sinuses. For purposes of comparison, in the other sinus we will place a few 
drops of a salt solution. The virus you will receive has been prepared at Genzyme 
Corporation in Framingham, Massachusetts. Then the tubes will be removed. You will 
be discharged from the hospital the next day. The treatment will be repeated up to a 
maximum of six times, for a total maximum of seven treatments. For the second through 
seventh treatments, you will be admitted to the hospitai a small tube will be placed into 
the sinuses as described above, the sinuses will be washed, the virus will be inserted, and 
then the tubes will be withdrawn. You will be discharged from the hospital the next day. 
We expect that the entire study will take about eight months. 
To determine whether the virus carrying CFTR is safe and can correct the cystic fibrosis 
respiratory abnormalities, we will perform several studies on days 1, 3, 7, 14 and 21 after 
the treatment. We will take swabs from both nostrils and your throat. The nasal and 
throat swabs are performed by gently rubbing a cotton-tipped applicator in the inside of 
your nose and in your throat. These procedures are commonly performed to diagnose 
"strep throat" and are not harmful or painful. 
Because this is an experimental vims, there is a possibility that inflammation of the lining 
of the sinuses or nose may occur. It is possible that redness and pain could occur or that 
you could develop symptoms similar to those experienced when you have a cold (that is a 
stuffy or runny nose) or a sinus infection (pain in the cheek, a headache, or a fever). To 
learn whether the treatments were effective or to learn if any harm was done, we will 
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