and physical, oxygen saturation tests, pulmonary function tests, adenovirus cultures, blood 
tests, and urine tests. Chest x-rays will be performed on days 84 and 112. Lung scans 
will be repeated on day 112. 
On days 84 and 112 I will have repeat measurements of the voltage inside my nose, nasal 
brushings and biopsies, and repeat bronchoscopies under intravenous sedation. 
BENEFITS 
If I participate in this study, I will be participating in one of the first studies of gene 
therapy for cystic fibrosis in human beings. These studies are being performed to 
establish whether it is safe to give this treatment and whether the treatment is feasible. 
It is unlikely that there is direct benefit to me by participating in this study, except for 
the benefit of very close medical attention and a free 2- week course of intravenous 
antibiotics. I understand that if gene therapy in cystic fibrosis is successful, there will be 
eventually be benefit to all cystic fibrosis patients including me. 
RISKS. DISCOMFORTS. AND PRECAUTIONS 
Participation in this study poses the following risks and discomforts for me: 
a. Pain, bruising, and potential infection at the site of blood sampling. During the 6 
weeks of the study, blood will be drawn 21 times, but no more than 20cc (4 tsp) 
will be drawn at one time. 
b. Pulmonary Function Testing: There are no significant risks associated with 
pulmonary function 'testing, which requires me to blow into a cardboard 
mouthpiece. 
c. Lung Scans: I will have the minor discomforts of lying on a hard surface while 
being scanned and breathing an aerosol. I will also have an injection of 
technetium-labelled protein for each perfusion scan. There have been no adverse 
reactions to this protein, but allergic reactions are a possibility. 
d. Fiberoptic Bronchoscopy: There are several risks associated with the 
bronchoscopy: 
1. Coughing: Spraying the back of the throat and the airways with 
lidocaine often causes coughing until the numbness takes effect. 
Coughing sometimes occurs when the bronchoscope is in the airway. 
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Recombinant DNA Research, Volume 17 
