altered virus could cause cancer. It also means that correction of the genetic defect in the 
lining of your sinuses will be temporary. 
The method for insertion of the tubes into your nose for washing the sinuses and for 
application of the virus may be uncomfortable. You will be required to sit still for about 
one hour without moving your head. The biopsy of the sinus 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, swelling, 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 and 
sinus 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 
temporarily increase the heart rate and amiloride, which is a "fluid pill" medication when 
taken by mouth. At the very low doses that will be applied to the lining of the nose, these 
medications should not cause problems. 
The drawing of blood from a vein or from an artery for blood tests could cause a bruise at 
the site, minor bleeding, and momentary pain. 
We anticipate that you will have up to a maximum of eight computerized tomographic X- 
rays of the sinuses during the course of the studies. Although there are no known adverse 
effects of this amount of radiation, the long term effects of such radiation are not known 
with certainty. The risk associated with the radiation that you will receive from this study 
is approximately three fifths the annual allowable exposure for a radiation worker. 
The altered adenovirus, could be dangerous to an embryo or fetus if you are pregnant; the 
risks are currently unknown. You will not be allowed to participate if you are pregnant. 
If you are a woman, we will do a pregnancy test. You will be asked to adopt some form 
of contraceptive precaution, such as oral contraceptives or an intrauterine device, during 
this experiment 
During the time that you are participating in this study you will remain susceptible to the 
problems that are normally associated with cystic fibrosis, such as infections of the lungs. 
If during the course of this study, you should develop a complication of your cystic 
fibrosis, we would initiate the appropriate treatment; for example, if you should develop 
an pneumonia, we would begin treatment with antibiotics. However, in that case, w'e 
would ask that you or your insurance company arrange for payment for the therapy. 
We do not expect that you will experience any major harmful effects of this study. 
However, because it could be of importance for future patients, an autopsy would be of 
value in determining the effects of the treatment. Therefore, in the unlikely event of 
death from any cause (for example, a traffic accident) during the course of the study, w'e 
will request that permission for an autopsy be granted. 
3. POTENTIAL BENEFITS TO YOU OR TO OTHERS WHICH MAY BE 
EXPECTED FROM THE RESEARCH : 
It is unlikely that participation in this study will directly benefit you. The correction of 
the genetic defect of cystic fibrosis will likely be limited to only the actual area where the 
virus was applied to the sinus. The primary benefit will be a better understanding of the 
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