10. Sperm count for males 
If a sperm count has not been done previously with the results documented, semen 
analysis will be performed by the Department of Urology, University of Michigan 
Center. 
1 1 . Bronchoscopy 
Patients will be allowed nothing by mouth for 6 hours prior to the procedure. They will 
be premedicated with 0.2 mg gly copyrrol ate and 50 mg meperidine intravenously 30 
minutes before bronchoscopy. Electrocardiogram, pulse rate, and pulse oximetry will 
be continuously monitored. Blood pressure will be monitored every 5 minutes by an 
automated noninvasive system. Viscous lidocaine 2% (30 ml) will be gargled and 
expectorated. Lidocaine 4% will be sprayed onto the posterior pharynx and larynx by a 
hand held atomizer. The bronchoscope will be introduced through the nose in patents 
without nasal obstruction or evidence of polyps. If the nasal approach cannot be used, 
the bronchoscope will be introduced orally. In patients undergoing bronchoscopy by the 
nasal route, oxymetazoline hydrochloride 0.05% will be applied topically to the mucosa 
of one nasal passage with a cotton swab. Lidocaine jelly 2% will be instilled into the 
same nasal passage. Supplemental oxygen by cannula will be administered at the mouth 
at 6 liters/minute. Midazolam will be administered intravenously in 1 mg boluses over 
15 seconds every 5 minutes until the patient is relaxed but still arousable by verbal 
stimuli. Additional midazolam will be administered in 1 mg boluses up to every 15 
minutes to maintain this level of sedation. A flexible fiberoptic bronchoscope will be 
introduced transnasally. Lidocaine 2% will be injected through the bronchoscope to 
anesthetize the larynx and airways as needed. 
12. Bronchoalveolar lavage 
50 ml aliquots of normal saline will be injected through the bronchoscope that has been 
gently wedged into a segmental bronchus. The lavagate will be aspirated into a suction 
trap. The procedure will be repeated until three aliquots have been administered and 
recovered. 
13. Mucosal epithelial cell brushing: A sleeved catheter with internal brush will be 
introduced into the bronchus [Kelsen, 1992]. The brush will be rubbed against the 
epithelial mucosa and the adherent cells removed by agitating the brush in sterile 
medium. 
14. Transbronchial biopsies: A biopsy forceps will be introduced into the bronchus and 
under fluoroscopic guidance six pieces of tissue will be taken. 
III.C. Clinical Protocol 
Screening evaluation Evaluation must be performed within four weeks of gene therapy. 
Written informed consent will be obtained prior to participation in the screening evaluation. 
Information obtained during screening will be: 
History and physical exam 
Clinical laboratory blood tests 
Sperm count on males 
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Recombinant DNA Research, Volume 16 
