M.J. Welsh and A.E. Smith, RAC Application 
rubber catheter. The rubber catheter and the skin patch will be connected to a voltmeter. 
A voltmeter is a recording device and does not deliver any electricity to your nose. Three 
different drugs at very low doses will be perfused onto the lining of the nose for 
approximately 30 minutes. These drugs are terbutaline (which is used to treat asthma), 
adenosine (which is used to treat abnormal heart rhythms), and amiloride (which is used 
to treat heart and kidney problems). These drugs are approved for human use, and at the 
low concentration used, do not have major side-effects. 
After the application of the virus you will be required to be in respiratory isolation for a 
period of approximately two to three weeks. 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 all visitors will be required to wear protective masks, gloves, and gowns. The 
period of time you will be kept in isolation depends on how long we can detect the live 
virus in your nasal secretions. We estimate that after 7 to 10 days there should not be any 
live virus in the secretions. The procedure to identify the live virus takes 7 to 8 days. 
This means that you will be required to stay in respiratory isolation for 2 to 3 weeks. 
About 2 tablespoons of blood will be drawn on days 1, 2, 3, 7, 1 1, and 15. Additional 
blood samples will be required on your follow up appointments which will occur at one 
to two week intervals for eight weeks after discharge. A chest X-ray, computerized 
tomographic X-rays of your sinuses, and repeat pulmonary function tests will be 
performed before you leave the hospital. 
2. FORESEEABLE RISKS AND DISCOMFORTS : 
Risks associated with gene therapy 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. 
The risks of these problems will be minimized by using small doses in patients in a very 
small area of 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. 
Other symptoms caused by 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 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, will not introduce the new gene into your chromosomes. This 
makes it exceedingly unlikely that the altered virus could cause cancer. 
The method for application of the virus may be uncomfortable, you will be require to sit 
still for about 60 minutes without moving your head. Placement of the plastic applicator 
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 
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Recombinant DNA Research, Volume 16 
