Revised 8-26-94 
have either a positive sweat chloride test and/or a CFTR genotype known to be 
associated with cystic fibrosis. The genotype of mutations of both CFTR 
alleles (abnormal DNA sequences) can be of any type associated with expression 
of the CFTR gene. 
If you are fertile, you must exercise appropriate birth control methods during 
and for at least 6 months after the last administration of the Ad^yCFTR.lO 
vector. We cannot be absolutely sure that the normal human CFTR gene being ad- 
ministered in Ad^vCFTR.lO will not be transferred to the sperm in males and 
the eggs in females . 
You must be at least 15 years old. This is for two reasons. First to be sure 
that your airways, being fully grown, are of sufficient size to allow 
repeated, safe, sampling via fiberoptic bronchoscopy. The second reason is 
that, by age 15, individuals are able to fully understand all the possible 
risks and benefits of participating in this protocol. 
If you are being treated in the lung, you must have lung disease typical of CF 
yet have a forced expired volume in one second (FEV1; a routine lung function 
test) of at least 1.2 liters. You may have typical respiratory manifestations 
of CF but still be able to undergo the various tests such as bronchoscopy 
which are needed to prove effectiveness yet require a certain minimum lung 
function to be performed safely. 
You must have a Shwachman score of 40 to 70 (mild to moderate disease) . This 
is a measure of the severity of CF based on various clinical requirements. The 
Shwachman score criterion is used to select typical individuals with CF whose 
disease is sufficiently mild or moderate that they are able to undergo the 
somewhat lengthy protocol without excessive problems. 
If you have digestive or liver disease, it must be mild and stable with ap- 
propriate therapy. Stable digestive and liver status are necessary to ensure 
that changes in the your non- respiratory status do not interfere with the 
evaluation of the impact of this experimental treatment with AdcvCFTR.lO on 
the respiratory manifestations of CF. 
If you have diabetes mellitus, it must be well controlled, such that you have 
experienced no episodes of diabetic ketoacidosis, hyperosmolar coma or attacks 
caused by exceedingly high or low blood sugar levels requiring hospitalization 
within the previous three years. This criterion is intended to ensure that 
changes in your non- respiratory status do not interfere with the evaluation of 
the impact of the experimental treatment on the respiratory manifestations of 
CF. 
You must be able to undergo bronchoscopy with brushing of the large airways, 
biopsy of the lung airways and bronchoalveolar lavage without complications. 
Fiberoptic bronchoscopy with brushing, biopsy and bronchoalveolar lavage is an 
important part of the protocol without which it is impossible to measure the 
safety and effectiveness of this treatment in those areas of the lung most 
severely affected. 
These procedures are safe and relatively easily tolerated. They are described 
in more detail later in this consent form. Some individuals may be unable to 
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