MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
‘STUDY NUMBER: 
CONTINUATION: page Jj>_ of 2_L pages. 
there have been no life threatening complications. However, individuals 
with CF have a higher incidence of mild complications with 
bronchoalveolar lavage than others. These complications include fevers 
(about 40% of CF individuals, usually self-limiting or relieved by anti- 
fever medications) and chills (about 20% of CF individuals, again self- 
limiting or relieved by anti-fever medications) , more infrequently (less 
than 5%) infections or coughing up blood. 
In individuals with cystic fibrosis, electrical charges on the respira- 
tory epithelial surface (the inside of the airway) are significantly 
more negative than in normal individuals. It is thus important to mea- 
sure these charges in study subjects during this protocol to see whether 
they return towards normal following administration of AdCFTR. An intra- 
venous (''i.v.") catheter is placed subcutaneously (just beneath the 
surface of the skin) in the arm and connected to an infusion of salt 
water. A second catheter, constantly rinsed with salt water, is placed 
on the surface of the airways to measure the charge there. This 
second catheter is placed on the airways through the bronchoscope. Both 
catheters are connected to a chart recorder which records the difference 
in electrical charge between the two surfaces. No hazards are anticipat- 
ed or special precautions required. 
All the bronchoscopy procedures combined will last between 35-50 min- 
utes. Once all the tests are performed the tube will be removed and the 
subject will return to his or her room. For three hours after the bron- 
choscopy the subject will not be allowed to eat or drink while the 
medicine and effects of the bronchoscopy wear off. Fiberoptic bronchos- 
copy will be performed a minimum of 11 times during the protocol: three 
in the baseline period, 4 in the vehicle control period, and 4 in the 
experimental therapy period. 
8. All male participants must undergo semen analysis in the baseline period 
to determine whether they meet the inclusion criteria of azoospermia (no 
sperm) . 
9. All female participants must have documented sterility (inability to 
have children) . 
Potential Risks : 
The potential risks of this protocol may be divided into two main types; those 
associated with the various tests and procedures designed to show effective- 
ness and safety and those associated with administration of a replication 
deficient adenovirus containing the normal CF gene to individuals with CFTR. 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
Recombinant DNA Research, Volume 16 
[787] 
