M.J. Welsh and A.E. Smith, RAC Application 
Ad2-ORF6/PGK-CFTR 
Item 5 - Clinical Protocol 
sinuses for one week. Instead, we will enter the sinus, rinse it free of mucus and debris, and instill the 
vector. 
Dose of Vector. 
Each participant will receive the same doses of Ad2-ORF6/PGK-CFTR: 
Administration Total IU 
1 5xl0 8 
2 2.5xl0 9 
3 2.5xl0 9 
4 2.5xl0 9 
5 2.5xl0 9 
6 2.5xl0 9 
7 2.5xl0 9 
Number of Repeat Administrations. 
In this part of the study, we plan to administer Ad2-ORF6/PGK-CFTR a maximum of 7 times. If we see 
evidence of clear improvement or clear worsening on the treated as compared to the control maxillary 
sinus, we will decrease the total number of administrations. Evidence of improvement or worsening 
would be obtained from two consecutive CT scans that showed a clear difference between the treated and 
control sinuses. The cytology, cultures, and cytokines measured in sinus fluid will also be evaluated. 
Alternatively, we would shorten the study if we obtain evidence of a systemic or local inflammatory 
response. At the completion of the study we will perform a biopsy of both sinuses to obtain histologic 
evidence of improvement or of injury. 
List of Evaluation Procedures. 
The following evaluation procedures will be performed as described in the Study Plan of Part A: 
a) History and Physical Examination; b)Blood/Serum by Venipuncture; c)Viral Cultures of Nasal and 
Pharyngeal Swabs, Urine and Stools; d) Swab of nasal mucosa for evaluation of an inflammatory 
response; e) Pulmonary Function Tests; f) Arterial Blood Gases; g) Voltage across the sinus epithelium. 
The following evaluations are specific to Part B: 
Evaluation of Fluid from Maxillary Sinuses. 
Purpose: To assess the severity of maxillary sinus disease. 
Methods: Fluid obtained at the time of initial sinus cannulation and then at the time of sinus lavage will be 
evaluated for quantitative bacterial cultures, cytology, cell counts, and cytokines and mediators including 
IL-16, IL-8, and TNF (44-46). It will also be evaluated for antibodies to adenovirus as described in part 
A. 
Computerized Tomography (CT) of the Sinuses. 
Purpose: To assess maxillary sinus disease. 
Methods: Computerized tomography (CT) of the sinuses will be performed at enrollment into the study. 
Subsequently, limited-cut CT will be performed, unless indicated by a change in clinical status. We will 
perform limited-cut maxillary sinus CT to minimize radiation exposure, yet still obtain a high resolution 
image for evaluation. Sinus CT will be performed in the Department of Radiology at the University of 
Iowa Hospitals and Clinics. Films will be evaluated in a blinded manner by Dr. Scott Graham and by 
physicians in the Department of Radiology. 
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Recombinant DNA Research, Volume 18 
