are approved for human use, and at the low concentration used, do not have major side- 
effects. 
After application of the virus you will be required to be in respiratory isolation for one 
day. We wish to keep you in isolation so that no one else will be exposed to the virus. 
This means that you will be confined to a hospital room and visitors will be required to 
wear protective masks, gloves, and gowns. 
About 2 tablespoons of blood will be drawn on the day of admission and discharge and 
on days 1, 3, 7, 14, and 21. Additional blood samples will be required with the additional 
four treatments. Computerized tomographic X-rays of your chest, and repeat pulmonary' 
function tests will be performed at the end of the study or if there is a change in your 
disease. 
2. FORESEEABLE RISKS AND DISCOMFORTS : 
Risks associated with gene transfer using the altered virus are largely unknown. It is 
possible that the virus could cause an inflammation locally at the site of application in the 
nose or it could damage the tissue in the nose. These problems might produce local pain 
or bleeding in the nose. There is also the very unlikely possibility of scarring in the nose. 
It is possible that the virus might reproduce under certain circumstances; this unlikely 
possibility might lead to spread of the virus and symptoms of a "cold". This may include 
nasal congestion, runny nose, sneezing, cough or fever. It is possible that a pneumonia 
could occur but this is very unlikely because we will only apply the altered virus to the 
lining of the nose. Other symptoms caused by naturally occurring adenoviruses include 
sore throat and red, sore eyes. Adenovirus that occurs naturally has been known to cause 
diarrhea and pneumonia, though these usually are caused by different types of adenovirus 
than that which was prepared for this study. If a lung infection or pneumonia did 
somehow occur, then it might cause a worsening of your symptoms of cystic fibrosis. 
Rare problems caused by adenovirus include an inflammation of the bladder. An 
extremely unlikely possibility is the formation of a new type of virus through interaction 
with other viruses. It is possible that participation in the study could cause your immune 
system to form a response against the altered virus. This could affect your response to 
subsequent treatments with the altered virus. It is also possible that you may develop an 
allergic reaction to the virus. The virus you will be exposed to, rarely introduces new 
gene into chromosomes. This makes it exceedingly unlikely that the altered virus could 
cause cancer. It also means that correction of the genetic defect in the lining of your nose 
will be temporary. 
The method for application of the virus may be uncomfortable, you will be required to sit 
still for about 30 to 40 minutes without moving your head. Placement of the small rubber 
tube in your nose could induce itching and sneezing. It is unlikely that the actual 
placement of the virus on the lining of the nose will cause significant discomfort. 
The biopsy of the nasal mucosa may be painful and a small amount of bleeding will be 
expected (about 2 tablespoons). After the biopsy, the healing process takes about 2 
weeks and some pain, itching, nasal discharge, and minor bleeding are expected. Pain 
killers will be available as needed. There is a small risk of infection at the site of the 
biopsy. 
The procedure involved in measuring the voltage on the inner surface of the nose does 
not cause pain and is unlikely to produce discomfort other than some itching. Two drugs 
will be applied to the lining of the nose; each is approved by the Food and Drug 
Administration for human use. The two drugs used are: terbutaline, which can 
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