The patients will be monitored with a variety of safety and efficacy parame- 
ters during the baseline, vehicle control and AdCFTR experimental therapy 
period. Some of the parameters will be used for both safety and efficacy 
assessment . 
5.5.1 Definitions 
The terms listed on the left will be used in the subsequent sections (5.5 
Safety and efficacy parameters, 5.6 Clinical protocol); The definitions of 
each term (i.e., the group of assays each term include), are listed on the 
right. 
General assessment 
- history, physical exam, vital signs (blood pres- 
sure, pulse, respiratory rate, temperature), weight 
Dyspnea index 
- subjective index defined by a questionnaire 
(Stoller et al . , 1986) 
General blood 
CBC , ESR 
- complete blood count, differential, platelets, 
erythrocyte sedimentation rate 
Clotting 
- prothrombin time, partial thromboplastin time, 
fibrinogen level 
Chemistry 
- sodium, potassium, chloride, total C0 2 , blood urea 
nitrogen, creatinine, alkaline phosphatase, alanine 
amino transferase, aspartate amino transferase, 
bilirubin (total), bilirubin (direct), total 
protein, albumin, calcium, magnesium, phosphate, 
uric acid, glucose, creatine phosphokinase , lactic 
dehydrogenase, cholesterol, triglycerides. 
Other 
- serum sample frozen for future use 
General immunity 
- anti-nuclear antibodies, rheumatoid factor, com- 
plement level (CH50) , complement components 3 and 
4, immunoglobulin G, immunoglobulin M, immu- 
noglobulin A, immunoglobulin E 
Culture 
- routine blood culture 
HIV 
- one pre- study test only 
Urine 
Routine 
- appearance, specific gravity, pH, protein, glucose, 
ketones, bilirubin, hemoglobin, number and 
type of cells, characterization of sediment 
Culture 
- routine urine culture 
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Recombinant DNA Research, Volume 16 
