Genzyme Corporation Ad2/CFTR-2 Gene Transfer Protocol: Single 
One Kendall Square, Cambridge, MA 02139 Aerosol Administration to the Lung of CF Patients 
Chest Radiography : A single PA and lateral view of the chest will be obtained as baseline for each patient. Although 
there are no known adverse effects of this amount of radiation, the long term effects of such radiation are not known 
with certainty. 
Pulmonary Function Tests : These tests are routine on outpatients with a variety of lung diseases including CF. No 
short or long term risks are anticipated 
Venipuncture : Venipuncture to obtain blood samples produces minimal risks that are well known. 
Potential Benefits 
It is very unlikely that participation will directly benefit the patient. If correction of the genetic defect of CF were to occur, 
the effect would likely be transient and in the case of lobar administration limited to the lobe exposed. The primary 
benefit will be the information obtained from this study regarding the safety of gene transfer by recombinant adenovirus 
in the lung. Such information is critical for further development of gene transfer for CF lung disease and a prerequisite 
to any studies using a repeat aerosolized dose. 
Risk Analysis 
The overall risks to the patient appear to be justified in view of previous preclinical and clinical data, study design and 
patient population, and the use of a viral/gene construct which is defective in its ability to replicate and which, even in 
wild-type form, is known to produce relatively mild disease in humans. 
ADVERSE EVENT MONITORING & REPORTING 
Patients will be closely monitored by the investigator(s) responsible for their care during their participation in this study. 
The clinical significance of adverse events will be determined by the investigator and medical intervention will be 
initiated if required. Adverse events will be reported to Genzyme, the FDA, and the IRB as required by Good Clinical 
Practices. Adverse events will be reported to the ORDA as required by NIH guidelines. 
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