Exclusion criteria 
1. Current unstable lung disease, i.e., worsening of pulmonary function or 
pulmonary symptoms of an "exacerbation" in the past three weeks. 
2. Hypoxemia with a pC>2 of < 60 mm Hg on room air. 
3. Lack of adequate birth control, i.e., women may be included if they have 
practiced contraception for at least one month and have a negative pregnancy test. 
4. Acute rhinosinus disease, including obstruction with nasal polyps, or 
recurrent sinusitis requiring repeated administration of antibiotics. 
5. Systemic corticosteroids within the past three months, or other 
immunosuppressive medications. 
6. Juvenile-type (insulin dependent and ketotic) diabetes mellitus. 
7. Current use of DNAse. 
8. Chronic adenoviral shedding. 
9. Participation in another therapeutic research study within 30 days. 
10. Patients with known mild variants (R117H; R75Q), especially those with 
pancreatic exocrine sufficiency. 
11. Inability to comply with the protocol. 
V.C. Clinical evaluation of patients 
Patients will be enrolled in the study at least four weeks before 
administration of the recombinant adenovirus and will be followed as outpatients at 
two week intervals until admission to the General Clinical Research Center 
(GCRC) for application of the recombinant virus. At the time of screening, patients 
will receive the evaluation outlined below, which will be repeated at the time of 
admission to the GCRC. Patients may also be evaluated with the following tests as 
appropriate for any change in clinical status. 
1. Complete history and physical exam, including nasal endoscopy. 
2. Genotyping for CF mutation. 
3. Pulmonary function tests, including spirometry and arterial blood gases. 
4. PA and lateral chest X-ray. 
5. Electrocardiogram 
6. Culture of sputum, nasal swab, throat swab, stool and urine sampling for 
wild type adenovirus. 
7. Bacterial culture of sputum. 
8. Nasal wash for inflammatory cell count. 
9. Blood for CBC, including platelets and differential; Chem 18, including 
general chemistries and liver function tests; adenoviral antibody titers, including 
serotyping, and for viral culture. 
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Recombinant DNA Research, Volume 17 
