If I decide to participate, I will be seen first for some initial studies in the clinical 
research center. These studies would decide whether or not I am eligible for this study. 
I will have a medical history, physical examination, EKG, chest x-ray, scans of my lungs, 
breathing tests, oxygen saturation measurement, brushings of cells from my nose, a 
bronchoscopy, cultures, blood tests, a urine test, a sputum culture, a genetic analysis for 
cystic fibrosis, a repeat sweat test, and a test for AIDS. If I am female, I will also 
receive a pregnancy test. 
After this initial evaluation period, I will be admitted to the clinical research center for 
about 4 l /2 weeks. I will be in isolation, but I will be allowed visitors who must follow 
isolation precautions. I will receive 2 weeks of intravenous antibiotics with aerosol 
therapy, chest percussion, postural drainage, and intensive nutritional support to prepare 
me for the study. After this 2-week cleanout, I will have my history and physical, chest x- 
ray, lung scans, oxygen saturation, pulmonary function test, viral cultures of throat and 
stool, blood tests, and urinalysis repeated. At that time the electrical voltage in my nose 
will be measured with a sensitive volt meter. 
On the following day, I will receive a small dose of the adenovirus CFTR construct into 
one nostril. This will be performed with local anesthetic to my nose. The doctors will 
examine the inside of my nose with a fine telescope and select an area where the virus 
will be given. 
One day later the electrical voltages within my nose will be measured again. I will also 
have a history and physical, culture for viruses, blood tests, and a urinalysis. 
On the following day (day 0) I will receive the construct into my lung. I will have a 
history and physical repeated. I will receive intravenous sedation and the inside of my 
nose and the upper airway will be anesthetized with lidocaine. Cells will be obtained 
from inside my nose by brushing, and a small biopsy will be taken. The bronchoscopy 
will then be repeated. Washings will be taken from two lobes within my lungs, the 
airways will be brushed with a fine brush to obtain cells, and small biopsies will be taken. 
I will then receive a dose of the adenovirus-CFTR construct directly into one selected 
lobe. This lobe will be selected on the basis of it being a typical lobe by chest x-ray and 
lung scan. The equivalent lobe on the other side will be used for comparison. At the 
end of the procedure, the doctors will "paint" the inside of my windpipe with the viruses 
mentioned. Blood tests and a urinalysis will also be performed this day. 
On day 3 (3 days after lung treatment) the bronchoscopy will be performed again as 
before, and the voltages will be measured within my windpipe. After measuring the 
voltages, the doctors will be able to anesthetize my windpipe and lower airways. 
Washings from the lung, brushings, and biopsies will be obtained. Chest x-ray, oxygen 
saturation, pulmonary function tests, blood tests, and a urine test will also be performed. 
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Recombinant DNA Research, Volume 17 
