Patient 
# 
90 day dose 
180 day dose 
Dose at 
each 
site 
(pfu) 
// of 
sites of 
admin- 
istra- 
tion 
Sites 
Dose at 
each 
site 
(pfu) 
# of 
sites of 
admin- 
istra- 
tion 
Sites 
1A, IB 
lxlO 7 
3 
Each site in 
same lung, 
each just dis- 
tal to lobes 
bronchus, same 
sites as part 
A 
lxlO 7 
3 
Same 
2A, 2B 
lxlO 7 5 
3 
Same 
lxlO 7 5 
3 
Same 
3A, 3B 
1x10 s 
3 
Same 
lxlO 8 
3 
Same 
4A, 4B 
lxlO 8 - 5 
3 
Same 
lxlO 8 - 5 
3 
Same 
5A, 5B 
lxlO 9 
3 
Same 
lxlO 9 
3 
Same 
6A, 6B 
lxlO 9 
3 
Same 
lxlO 9 
3 
Same 
7A, 7B 
lxlO 9 
3 
Same 
lxlO 9 
3 
Same 
The time intervals for assessment of expression are detailed in the time line 
in appendix 5.5. 
9.1 Management of Intercurrent Illness. The natural history of cystic fibrosis 
is associated with exacerbations of the disease, particularly the respiratory 
manifestations (1). In this context, it is possible that among the individuals 
in this protocol, exacerbations of respiratory infections and/or decrement in 
clinical lung- related parameters will occur during the baseline period, vehi- 
cle control period, or AdcvCFTR.10 treatment period. Further, the natural his- 
tory of the disorder suggests it is possible that exacerbations of manifesta- 
tions of the disease in other organs might also occur. 
All patients in the study will enter the study with the same therapy that is 
generally prescribed for them by their usual treating physician (see section 
1.2). Should intercurrent exacerbations of disease of any organ occur either 
during initial assessment or after therapy with the vector, the patients will 
be treated by conventional clinical therapy at the discretion of the physi- 
cians caring for the patient. During the period of intercurrent illness, as- 
sessment of safety and efficacy parameters will continue as defined by the 
protocol as long as such assessment does not interfere with the clinical care 
and welfare of the patient. 
If intercurrent illness occurs during the baseline period or vehicle control 
period, efforts will be made to determine if adenovirus is involved by nasal, 
pharynx, urine and rectal culture. If adenovirus is definitively shown to be 
involved, the individual will be removed from the protocol and not allowed to 
enter the Ad^CFTR.lO treatment period. If the intercurrent illness during the 
baseline or vehicle period control period is sufficiently severe to preclude 
continuation of the protocol, the individual will be removed from the proto- 
col. If intercurrent illness occurs during the Ad^vCFTR-lO treatment period, 
Recombinant DNA Research, Volume 20 
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