MJ. Welsh and A.E. Smith, RAC Application 
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. Three drugs 
will be applied to the lining of the nose; each is approved by the Food and Drug 
Administration for human use. The three drugs used are: terbutaline, which can 
temporarily increase the heart rate; adenosine, which may induce difficulty breathing if 
inhaled by asthmatics; 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 a subject will have three chest X-rays and two 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 less than that from the average background radiation exposure received 
by each member of the general public in one year. 
Isolation in a room for 2 to 3 weeks could have a psychological impact. We will try to 
offer entertainment (VCR, reading material, games), a stationary bicycle and 
psychological assistance, if needed. 
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 precautions 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, we 
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 die treatment. Therefore, if you should die from any 
cause (for example, a traffic accident) during the course of the study, we will request that 
permission for an autopsy be granted. 
3. POTENTIAL BENEFITS TO YOU OR TO OTHERS WHICH M AT3L 
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 nose. The primary benefit will be a better understanding of the 
possibilities for gene therapy with the altered virus in cystic fibrosis. In particular, 
information regarding the amount of virus needed and the effects of the virus on the cells 
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