M.J. Welsh and A.E. Smith, RAC Application 
assistance, if needed. On the Certification of Subject Consent, we identify a person that the 
patient may contact for complaints and for help in protecting their rights and welfare. 
C. SELECTION OF PATIENTS, 
Estimate the number of patients to be involved in the proposed study. Describe 
recruitment procedures and patients eligibility requirements, paying particular 
attention to whether these procedures and requirements are fair and equitable. 
C.l. How many patients do vou plan to involve in the proposed study? 
Three. 
C.2. How many eligible patients do vou anticipate being able to identify each year? 
All three patients will be identified in the first year. 
C.3. What recruitment procedures do vou plan to use? 
The patients will be referred to the study for consideration by his/her physician. We 
anticipate, but do not require, that most participants will be patients at the University of 
Iowa Hospitals and Clinics. 
C.4. What selection criteria do vou plan to employ? What are the exclusion and inclusion 
criteria for the study ? 
Inclusion Criteria 
a. Patients with CF with mild to moderate severity of disease. Patients should score above 
70 using the CF NIH scoring system (150). 
b. Male or female patients, age greater than 18 years. 
c. CF genotype: AF508 homozygous is preferred. If patients homozygous for AF508 are 
not available, we will use patients who are AF508 compound heterozygotes. In the case of 
AF508 compound heterozygotes, the mutation on the other chromosome must be known to 
cause CF and must not be associated with a milder clinical phenotype. 
d. Seropositive for antibody to adenovirus. Seropositivity is very common (greater than 
70%) in the general population (76). Seropositivity is required to insure a rapid and 
adequate immunologic response to the virus and to minimize any potential for 
dissemination of the virus. 
Exclusion Criteria 
a. Current instability of respiratory status. 
b. Hypoxemia with P a C>2 less than 66 mm Hg. 
c. FEVi less than 50 % of predicted. 
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Recombinant DNA Research, Volume 16 
