M.J. Welsh and A.E. Smith, RAC Application 
d. Weight for height (%) less than 90% of predicted. 
e. Pregnancy: all subjects must practice contraception for at least one month and will have 
a negative test for pregnancy. 
f. Patient has school age children. 
g. Chronic severe nasal/sinus disease, either infectious or allergic in nature. Persistent 
purulent nasal discharge, obstructing nasal polyps, significantly inflamed nasal mucosa, or 
symptomatic sinusitis requiring repeated antibiotic therapy will exclude patients from the 
study. 
h. Upper respiratory infection of patient or household member within two weeks prior to 
entry. 
i. Corticosteroid therapy within the last 4 months. 
j. Current use of inhaled DNase therapy. 
k. Chronic adenoviral shedding within six weeks of study as detected in blood, urine, and 
nasal swabs. 
l. Patients may be excluded after the initial evaluation if PCR of the cells brushed from the 
nasal epithelium shows evidence of adenovirus 2 or 5 El genes (detected by PCR as 
described in Point B.l.b(l)(b) 8). 
m. Subjects may not participate in other research protocols during the proposed study. 
n. Inability to comprehend nature of the study or to give informed consent. 
C.5. How will patients be selected if it is not possible to include all who desire to 
participate? 
Those first three patients judged most able to participate in the investigation will be chosen. 
D. INFORMED CONSENT 
Indicate how patients will be informed about the proposed study and how their 
consent will be solicited. The consent procedure should adhere to the requirements of 
DHHS regulations for the protection of human subjects (45 Code of Federal 
Regulations. Part 46). If the study involves pediatric or mentally handicapp ed 
patients, describe procedures for seeking the permission of parents or guardians and, 
where applicable, the assent of each patient. Areas of special concern highlighted 
below include potential adverse effects, financial costs, privacy, long-term follow-up 
and post mortem examination. 
D.l. How will the major points covered in Sections I-A through I-C of this document be 
disclosed to potential participants in this study and/or parents or guardians in 
language that is understandable to them? 
In accordance with 21 CFR Part 46, informed consent to participate in this clinical study 
will be obtained from the patient by the investigator prior to initiating treatment. The 
patient will receive a copy of the Information Summary to read and discuss with the 
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