Post bronchoscopy monitoring 
Vital signs including blood pressure, pulse, temperature, and respiratory rate will be measured 
and recorded every five minutes for the first hour, every 15 minutes for the next two hours, 
every one hour for the next six hours, and every two hours for the next 15 hours, and every 
four hours for the rest of the week post-transfection. Continuous electrocardiographic and 
pulse oximetry will be measured for the first 24 hours. The clinical laboratory blood tests that 
are listed above, pulse oximetry, and PA and lateral chest x-rays will be performed daily for 
the first week, twice a week for the second week, and weekly thereafter for six weeks. Thin cut 
CT scans will be performed on the day prior to the follow-up bronchoscopy. 
Following the administration of virus the patients will be kept in an isolation room with full 
respiratory precautions. This involves a negative pressure room in which the air is filtered 
and delivered outside. Anyone entering the room will were a gown, mask, eye protection, and 
gloves. The patient will be in isolation for at least 10 days after initiation of therapy. While in 
the hospital the patient will have his/her sputum, nasal swab, urine and stool analyzed for 
replication competent adenoviruses of any serotype using standard adenovirus assays. These 
samples will also be evaluated for CFTR recombinant virus using the PCR assay described in 
sections IV.D.2.e. In the unlikely event that the patient continues to shed recombinant CFTR 
adenovirus in the airway, he/she will be kept in the hospital for a longer period of time. 
Schedule for post-transfection bronchoscopies 
Day 4 (transfection on day 0) 
Day 42 
Day 90 
Samples and measurements obtained during post-transfection bronchoscopies 
a) Transepithelial electrical potential difference at four sites within the transfected 
segment and within the segmental bronchus of its mirror image in the opposite 
lung. 
b) Bronchoalveolar lavage of transfected segment and its mirror image in the 
opposite lung. 
c ) Six cytological brushings of alveolar surface from the transfected segment 
d) Six transbronchial biopsies from the transfected segment. 
III.D. Evaluation of therapy 
The patient will be carefully monitored for toxicity, immunological response to CFTR protein or 
adenoviral proteins and efficiency and stability of gene transfer. 
1 . Toxicity - Serial examinations to include PFT's, blood chemistry, hematology and 
cultures for adenovirus will be performed. Bronchoalveolar lavage fluid obtained during 
each follow-up bronchoscopy will be carefully analyzed for wild type and recombinant 
virus. 
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Recombinant DNA Research, Volume 16 
