them an opportunity to exercise and to relieve stress and boredom. We will also provide them 
with any books, tapes, or magazines that they might wish to read or listen to. 
5.3 Potential discomfort and risk 
Venipuncture: Drawing of blood for these studies involves a small prick of the skin. 
Sometimes patients become faint, and occasionally there is bruising at the site of venipuncture. 
The risk for serious complication is small. 
Pulmonary function testing: There are no significant risks associated with pulmonary function 
testing. 
Perfusion scans, CT scans, and mucociliary clearance: 
Risk : Allergy and toxicity are not known to occur. Each set of tests (aerosol, SPECT 
perfusion, and thin section CT, with a reduced number of sections) will be equal in dose to the 
average absorbed dose to lung in the standard thin-section CT protocol. 
Discomfort : There will be the minor discomforts of lying on a hard imaging table (twice) 
and inhaling an aerosol by mask or mouthpiece. There will be a single venipuncture (for 
injection of Tc-99m-MAA for lung perfusion SPECT). 
Fiberoptic bronchoscopy: The risks of bronchoscopy and bronchoalveolar lavage are those 
associated with hypoxemia due to the bronchoscopy itself, especially in patients with advanced 
lung disease. In our experience, with necessary precautions, if the oxygen saturation is greater 
than 90% at the time of bronchoscopy, then desaturation will not be a significant problem. All 
patients will be monitored with oximetry during the brpnchoscopy, and if they have saturations 
less than 90%, supplemental oxygen will be administered. 
Bleeding, pneumothorax, and respiratory arrest are potential complications of bronchoscopy 
and lavage, but they have not been encountered to date in cystic fibrosis patients receiving only 
fiberoptic bronchoscopy and bronchoalveolar lavage 
It is possible that bleeding will develop following bronchial biopsy. This is a well 
established clinical procedure, and the risk is relatively low. The instance of moderate or severe 
bleeding when coagulation is normal is less than 1%. Serious bleeding is very uncommon and, 
when it occurs, usually affects patients affected by a coagulation disorder. 
Vector related risk: There are several safety issues related to the use of a replication-deficient 
recombinant adenovirus to correct the respiratory aspects of cystic fibrosis. These risks include: 
1. Will the adenovirus become infectious? 
2. Will the vector express viral genes? 
3. Could the CFTR gene be transferred to the germ line? 
4. Do anti-adenoviral antibodies develop? 
5. Will the patients become immune to the adenovirus vector? 
6. Does administration of the recombinant adenovirus cause infection of the lung with possible 
inflammation? 
7. Could the vector transform respiratory cells and cause malignancy? 
8. Could over-expression of CFTR lead to deleterious changes in the recipient’s lungs? 
Recombinant DNA Research, Volume 17 
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