MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Partic ! ~— ■- A r ' ,ir,s# *“ l D “ e “ ai "* h Qt,,Hw 
STUDY NUMBER: 
nostril. The nose is inspected and a small brush is passed through the 
speculum and gently brushed over the inner surface of the nose. Both the 
vehicle alone and the AdCFTR will be administered through the nasal 
speculum at the appropriate times during the protocol. In the nasal 
epithelium of individuals with CF the electrical charge is more negative 
than in other individuals. It is thus important to measure these charges 
in study subjects during this protocol to see whether they return to- 
wards normal following administration of AdCFTR. To do this an intrave- 
nous catheter (i.v. needle) is placed subcutaneously (just under the 
skin) in the arm and connected to an infusion ("i.v.") of salt water. A 
second catheter is constantly rinsed with salt solution and is placed on 
the inner surface of the nose, through the nasal speculum to measure the 
charge there. Both catheters are connected to a chart recorder that 
records the difference in electrical charge between the two surfaces. No 
hazards are anticipated or special precautions required. 
7. Fiberoptic Bronchoscopy. Bronchoscopy is uncomfortable but not painful. 
The subject's mouth, throat and nose will be anesthetized (numbed) with 
lidocaine (a medicine similar to that used by dentists to numb teeth 
prior to filling or extracting them) which can be used directly on the 
airway surface, that is without being injected by a needle. It may have 
an unpleasant taste. A small intravenous needle will be placed into the 
forearm as part of the preparation and may cause local discomfort. The 
subject will receive the drug atropine before the procedure, which may 
cause the sensation of mouth dryness. As a safety precaution the subject 
is then given oxygen gas through the nose. The bronchoscope (a long, 
thin, flexible tube) will be introduced into the nose (or mouth if 
necessary) and passed down the breathing tubes into the lungs; the 
subject may cough; this is normal and will be controlled as much as 
possible by the doctor and nurse performing the procedure. Both the 
vehicle alone and the AdCFTR will be administered through the broncho- 
scope at the appropriate times during the protocol. When the broncho- 
scope is in place a small brush may also be placed through the broncho- 
scope onto the surface of the airways and the airway gently brushed. 
This is a painless procedure and is very safe, the only common problem 
being some slight bleeding at the site of the brushing. This is rarely 
of any clinical significance (will not affect your health) . When the 
brushing have been performed the patient will then undergo bronchoalveo - 
lar lavage. This involves wedging the bronchoscope into the air passages 
of a small part of the lung and instilling salt water through the bron- 
choscope so as to gently wash the inner surface of the airways. Once the 
salt water has been instilled it is then gently suctioned out of the 
lung and collected. This procedure is safe. In over 2000 bronchoalveolar 
lavages performed by Pulmonary Branch personnel over more than a decade, 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
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Recombinant DNA Research, Volume 16 
