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Imedical 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_L?of 1L pages. 
the major airway on the left side of the lung. This will be administered 
through a bronchoscope. The volume will be 20 milliliters, about 4 teaspoons. 
The participant will then be observed for any reactions to this dose of 
vehicle or to the method of delivery. As in part 1, a variety of tests will 
be carried out. The vehicle control phase will last one month. Details of 
the vehicle control period can be found in section 5.6.3, of the protocol and 
the schedule of all tests in this period can be found in Table 5. 6. 3 -A. 
If the subject wishes to continue the protocol and still meets all the inclu- 
sion and exclusion criteria, he or she may move on to the third part of the 
protocol: the AdCFTR experimental treatment period. On entering the AdCFTR 
experimental treatment period of the protocol the two individuals in each 
group will be staggered by a minimum of 1 week. This means that the individu- 
als will enter this part of the protocol 1 week apart. This is to ensure that 
no serious acute adverse reaction has occurred in the first person at the dose 
level for that group before the second person from that group is started. 
Details of the AdCFTR experimental treatment period (part 3) can be found in 
section 5.6.4 of the protocol, and the schedule of tests in this period can be 
found in Table 5.6.4-A. 
On day 1 of the AdCFTR experimental treatment part of the protocol, the study 
individual will receive AdCFTR, the modified adenovirus containing the normal 
CFTR gene. To minimize the risk of infection with a different naturally 
occurring virus for the 10 days before administration of AdCFTR, the study 
individual will be isolated, that is, requested to remain within the confines 
of the NIH Clinical Center. While in his or her room, no special precautions 
are needed but when going outside the room gloves and masks are required. 
Hospital staff and visitors (must be over 15 years of age) when visiting the 
study participant will be required to wear a gown, mask, and gloves 10 days 
prior to his or her receiving AdCFTR. Further, there will be a careful 
evaluation prior to administration of AdCFTR to ensure that no viral illness 
is present. AdCFTR will then be administered to the left nostril through a 
nasal speculum in exactly the same manner as the vehicle alone was adminis- 
tered in part 2 of the protocol (the volume administered will again be 0.2 
milliliters, that is about 4 drops). The study subject will be monitored for 
24 hours . 
If there are no adverse reactions, the AdCFTR will then be administered (as 
was done for the vehicle) to the major airway of the left side of the lung 
through the bronchoscope in a volume of 20 milliliters (about 4 teaspoons) . 
To ensure that AdCFTR, or a combination of AdCFTR and other viruses, does not 
spread to others after administration of AdCFTR the participant will be kept 
in isolation (as described above) until it is proven that there is no AdCFTR 
or replication competent adenovirus (adenovirus that can reproduce itself) 
present In secretions from his/her nose, pharynx, urine or rectum tested 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
Recombinant DNA Research, Volume 16 
[783] 
