Kesponses to initxai Review RAC Application Kenneth L. Brigham, M.D. 
Appendix B 
PRINCIPAL INVESTIGATOR; Kenneth L. Brigham. M.D. 
TITLE OF PROPOSAL; Expression of an Exogenously Delivered Human Aloha- 1 Antitrypsin Gene in Nasal 
Epithelium 
ITEM #1 (Continued); 
Two other laboratory tests are also part of this study. Before we put the gene in your nose, we will obtain 
a small amount of blood from a vein in your arm to measure various laboratory values. 48 hours after we put the 
gene in your nose, we will repeat these same laboratory tests on another blood sample and compare these laboratory 
values to your baseline. The total amount of blood will be about 4 tablespoonfuls. The other laboratory tests we 
will do are x-rays of your sinuses. The sinus x-rays are additional x-rays which you normally would not receive. 
The additional amount of radiation that you will receive from one 4 film skull series (sinus x-rays) is about the 
same as six weeks of natural background radiation. We will obtain a baseline x-ray of your sinuses before we put 
the gene in and then 48 hours afterwards to evaluate for the presence or absence of sinusitis. Both the blood draws 
and sinus x-rays are routine medical tests that are done daily. The costs for the laboratory work and x-rays will 
I be covered by the Department of Pulmonary and Critical Care Medicine. 
If you are on alpha 1 -antitrypsin protein replacement therapy (Prolastin), you will have to stop this one 
, month before this study to insure that the alpha 1 -antitrypsin values that we obtain during the study are due to the 
gene that we put in your nose and not from the Prolastin. Also, if you are on any nasal inhalers, these will need 
to be stopped during the study (for one week). 
ITEM #2; The parts of this study that are being done solely for this study are; 
What we propose to do is entirely for the purpose of this study. 
Recombinant DNA Research, Volume 19 
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