5) NOT have been treated with antibiotics by vein or have been hospitalized during the 
preceding 30 days for treatment of their lung disease ; 
6) NOT have certain types of bacteria that are difficult to treat with antibiotics growing in 
their sputum; 
7) NOT have had recent coughing up of blood severe enough to require medical treatment, 
or coughing up of blood on a weekly basis; 
8) NOT be involved at the moment in studies of other experimental treatments 
9) NOT be a cigarette smoker; 
Eligible patients may have to wait to participate in the study if they are actively infected at 
the time of the start of the study with certain "cold" viruses, since these viruses might 
interact with the gene transfer virus. 
You may participate in the trial if you meet all the requirements listed above and are willing 
to undergo the procedures described below. 
DETAILED PROCEDURES: 
The study involves a very extensive series of procedures taking place over an 18-day in- 
hospital stay, and a 1-year period of regular outpatient follow-up. Each patient will serve 
as his/her own control, so that studies will be performed at the beginning of the study 
(baseline period), after administration of a salt-water solution without the virus (vehicle 
control period), and then after administration of the gene transfer virus. A single dose of 
virus will then be administered to patients in this study. Every person in the study will 
receive a dose of virus, but some will receive very low doses. If patients receiving the low 
dose do not have severe side effects, the dose will be increased in subsequent groups of 
patients. At the time of each administration, doses will be given both to the nose and to the 
lung by fiberoptic bronchoscopy. 
Groups . This study will include 8 groups of 2 patients each (see table below). The initial 
group (Group 1) will be treated with 10 6 (1 million) vector particles intranasally. Groups 2 
through 6 will receive the same dose of vector to the nasal epithelium and to the bronchial 
epithelium of the superior segment of the right lower lobe (RLL) through the suction port 
of the fiberoptic bronchoscope. Group 2 will receive 1 x 10 7 (10 million) vector particles 
at each site, and the doses in subsequent groups will increase in roughly 3-fold increments 
up to a maximum of 1 x 10 9 (1 billion) intranasal (Groups 6,7,8) and 1 x 10 10 (10 billion) 
endobronchial (Group 8). The patients within each group will be staggered by at least one 
week and each group will be staggered by at least one month to allow for evaluation of 
acute toxicity. 
Recombinant DNA Research, Volume 20 
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