6 . 
Risks, discomforts and Inconveniences of the research 
1 . Blood tests. During the entire 3 month period of the study, less than 1 unit (1 pint) 
of blood will be drawn for tests. You may develop a bruise or bump at the site of the needle 
puncture. Sometimes subjects get light-headed and on rare occasions faint when blood is 
drawn. 
2. Bronchoscopies, 
bronchoscopy. 
Several types of risks and discomforts can occur from 
3. 
a) Cough. Spraying the back of the throat with local anesthetics causes coughing 
and gagging until the numbness takes effect. Coughing also occurs when the 
bronchoscope is in the airway. 
b ) Pneumothorax. When pieces of lung tissue are taken, an air leak can occur on 
the surface of the lung. The leak allows the lung to collapse partially or totally. 
Depending on the amount of collapse and the patient's symptoms, a tube may need to 
be inserted though an incision between the ribs to suck out the air. If used, the tube 
usually remains in place for 2-5 days, during which time the air leak almost always 
stops. If it does not stop, an operation may be required to repair the leak. The 
chances of a collapsed lung are approximately 2 in 1 00 patients. When a collapsed 
lung occurs, a tube is needed in approximately 1 in every 2 or 3 patients. For those 
patinets who do not need a tube, the air goes away by itself in about 2 weeks. When a 
tube is needed, it is almost always effective. An operation is needed in less than 1 in 
500 cases of collapsed lung that requires a tube due to biopsy. 
c) Bleeding. Brushing the lung and taking small pieces (biopsies) can cause 
bleeding. In almost all cases, the bleeding is very scant and stops quickly. In rare 
cases, the bleeding is more severe. The bronchoscope can be used to temporarily 
plug the bleeding airway and allow the bleeding to stop. In very rare cases (less than 
6 in 1,000 patients) the bleeding is more severe. Even in these cases, blood 
transfusion is almost never needed. Bleeding bad enough to need an operation or 
cause death is extremely rare and has not occurred in patients at the University of 
Michigan who have had normal blood clotting and don't have cancer. 
d) Fever. After fluid is injected and sucked out of an area of lung, fever can occur 
during the next 24 hours (1 in 5 chance). 
e) Pneumonia. An infection (pneumonia) can develop in the part of the lung where 
fluid was injected (1 in 20 chance). If this occurs you may experience increased 
shortness of breath, cough, and fever. 
f ) Allergic reactions to the medications. These are extremely rare (less than a 1 
in 1,000 chance). 
Complications caused by the virus. 
a) Over production of cystic fibrosis protein. The gene therapy may cause more 
than the normal amount of cystic fibrosis protein to be produced in the cells of the 
airway. Tests in animals have shown that airway cells which produce over 100 
times the normal amount of cystic fibrosis protein appear normal. It is not known if 
this will be the same in humans. 
b ) Multiplication of the virus. The virus that is being used to transfer the cystic 
fibrosis gene into your airway cells has been made so that it cannot reproduce by 
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