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 
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STUDY NUMBER: CONTINUATION: page_Lof 21_ pages. ' 
clinical reasons, for example markedly abnormal clotting parameters, (a 
tendency for easy bleeding) , allergies to local anesthesia (numbing medicine) 
or markedly difficult entry through the air passages (difficulty tolerating 
the placement of the fiberoptic tube in the airways) , 
Study subjects should not be taking experimental medicines relevant to the 
lung disease of CF for at least 4 weeks prior to entry into study. Such 
medicines include recombinant human DNase, alpha 1-antitrypsin, recombinant 
secretory leukopro tease inhibitor, or amiloride. If study subjects were on 
these medicines it would be difficult to understand whether changes or 
improvements were due to the gene therapy treatment in this protocol or to 
these other experimental medicines. 
Study subjects should be able to stay at the NIH Clinical Center for a minimum 
of 4 months. Additionally, they will be asked to return to the Clinical 
Center once a month for 10 months, at 6 month intervals over the next year, 
and then once yearly thereafter. This is in order to test for safety and 
effectiveness of the treatment during the administration part and follow-up. 
Assessment of airway epithelium of study candidates should show no evidence of 
adenovirus type 5 Ela sequences (genes from naturally occurring adenoviruses). 
This is in order to prevent, as far as possible, any contact between naturally 
occurring adenoviruses and the AdCFTR virus. Such contact could possibly 
enable the AdCFTR virus to reproduce or give rise to a new virus by 
incorporating parts of the AdCFTR virus with other viruses. 
Cultures of bronchial brush, nasal brush or bronchoalveolar lavage samples 
from study subjects must not demonstrate evidence of adenovirus, 
cytomegalovirus, varicella-zoster virus, herpes simplex viruses I and II, 
influenza viruses A and B, parainfluenza viruses 1, 2 and 3, or respiratory 
syncytial virus. As described above, these criteria are designed to prevent 
contact between AdCFTR and other viruses . 
To enter the protocol, individuals must have airway cells that do not support 
the replication (the capacity of the virus to reproduce itself) of AdCFTR. 
This is to ensure that the AdCFTR virus will remain replication incompetent 
when infecting (ferrying the normal CF gene to) the study subject's lung 
cells . 
Study subjects should have no history of allergy to glycerol (part of the 
solution used to carry the virus) or to medicines used in the bronchoscopy 
procedures. This is to minimize any potential for allergic reactions. 
Study subjects should have no history of documented tracheobronchitis and/or 
pneumonia caused by an adenovirus (the virus used as the framework for 
AdCFTR) . 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
[778] 
Recombinant DNA Research, Volume 16 
