I 
Other major risks of the study are produced by the drugs used to put you to 
sleep for the bronchoscopy and from the bronchoscopy procedure you will have. 
Patients with a history of lung disease can have problems caused by the drugs 
used to put you to sleep. You could have a drop in your oxygen levels, or 
experience wheezing or coughing. There is a chance that the drugs could stop 
your breathing. If this happened, we would have to pass a tube through your 
mouth into your windpipe to help you to breathe. You might need some extra 
oxygen if you have problems after we put you to sleep. If you had breathing 
problems after the bronchoscopy procedure, we do not expect that they would 
last long. They should get better when the drugs begin to wear off. We will 
watch you carefully during this time. 
Other side effects you could have would be nosebleeds, fevers, drops in blood 
pressure, or bleeding from the lung. Nosebleeds can be caused by nasal 
brushing or when we do the nasal voltage measurements. All of the study 
procedures and measurements will be performed by doctors who have experience 
with the procedures and measurements will be performed by doctors who have 
experience with the procedures and who put patients to sleep for these 
procedures. If they decide that you are having side effects that cannot be 
managed easily, they will stop doing the measurements or procedures. The 
insertion of a needle into your veins to collect the blood we need for testing 
may cause temporary pain, bleeding or a bruise at the site. 
You will receive three chest X-rays and three chest CT studies. The radiation 
exposure you will receive from the study is equivalent to an exposure of 1.1 
rems to your whole body. Naturally occurring radiation (cosmic radiation, 
radon, etc.) produces whole body radiation exposures of about 0.3 rem per 
year. Occupationally exposed individuals are permitted to receive whole body 
exposures of 5 rems per year. 
We believe that receiving the altered AAV-CFTR virus will not hurt you. There 
is always the possibility that cystic fibrosis patients may die of their 
disease or from other causes. If you should die either during or after you 
participate in this study, we will ask your family for permission for an 
autopsy. This would allow us to find out how the altered gene affected you and 
such information might help future patients. You and your family do not have 
to agree to allow an autopsy to be done in order to join the study. 
BENEFITS : We do not think vour heath will improve if vou -join this study . 
Therefore, you will not benefit personally from being part of this first study 
of AAV-CFTR gene transfer. The use of the altered AAV virus carrying the CFTR 
gene WILL NOT CURE your cystic fibrosis. We hope, however, that the results of 
this study will give us information to use in the next step of developing gene 
transfer to try to help cystic fibrosis patients be cured of the disease. 
NEW INFORMATION: Any new information generated during the course of this study 
that might affect your continued participation will be given to you by your 
doctors. This includes new information about the procedures used, the virus, 
or physical reactions other patients in the study have had. 
COSTS AND PAYMENTS : The eighteen day hospital stay will be free of charge. 
Neither you nor your insurance company will be charged for any tests or 
procedures in the research study. We will provide $50 for each research study 
clinic visit you must make after you are discharged from the hospital and will 
also give you free parking for these visits. There is no other financial 
compensation for participation. If you suffer an adverse effect that requires 
medical treatment, you will be treated for this problem. However, The Johns 
Hopkins University, The Johns Hopkins Hospital, Targeted Genetics Corporation, 
[144] 
Recombinant DNA Research, Volume 20 
