efflux, SPQ dye); expression of CFTR protein 
( immunohis tochemis try , immunoprecipitation with 
kinase reaction, 35 S -methionine metabolic labeling 
and immunoprecipitation) ] 
Bronchial brush 
Potential difference 
Vector -related 
Anti -Ad antibodies 
Adenovirus culture 
Adenovirus DNA 
Serum TNF - 
- cell number, type, culture (routine and quanti- 
tative bacterial culture, virus culture), biologic 
efficacy (same as for nasal brush) 
- nasal, bronchial (if bronchoscopy performed) 
- anti-AdCFTR, anti-Ad5 (serum and lavage fluid if 
bronchoscopy performed) 
- blood, rectal, urine, pharyngeal, nasal brush (if 
performed), bronchial brush (if performed) 
- specific DNA sequences from AdCFTR (CFTR cDNA) and 
from wild type Ad5 (Ela) - evaluated in blood, 
nasal brush (if performed), bronchial brush (if 
performed) 
levels of tumor necrosis factor 
5.5.2 Safety Parameters 
The patients will be monitored with a variety of safety parameters during the 
baseline, vehicle control, and AdCFTR experimental treatment periods. The 
safety parameters are divided into two categories, "general clinical 
parameters" to monitor the individual's overall status as well as specific 
organ systems, and "vector-specific parameters" specifically relevant to the 
administration of a replication deficient recombinant adenovirus. The 
definitions for each group of parameters are in Section 5.5.1. The times of 
assessment of each parameter are detailed in Section 5.6. 
5. 5. 2.1 General Clinical Safety Parameters 
The general clinical safety parameters include (see Section 5.6 for specific 
times of evaluation) : 
General assessment 
Dyspnea index 
General blood (CBC, ESR, clotting, chemistry, other, general immunity, 
culture, HIV) 
Urine (routine, culture, 24 hr) 
Sterility evaluation 
EKG 
Roentgenographic (chest X-ray, chest CT) 
Scintigraphic (V/Q) 
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Recombinant DNA Research, Volume 16 
