The purpose of this study is to evaluate the efficacy, tolerability, and safety of BEZ235 alone and in combination with RAD001 to support further development to reduce the incidence of respiratory tract infections (RTIs) in elderly subjects.
This is a randomized, blinded, placebo-controlled, multicenter, parallel-group, dose finding 24-week study to assess the safety, tolerability and efficacy of up to 3 doses of BEZ235 alone and in combination with RAD001 as compared to placebo in elderly subjects who are at increased risk of respiratory tract infection related-morbidity and mortality. The study will be composed of up to a 6-week screening and run-in period, a 16-week treatment period and an 8-week follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
652
Heartland Research Associates
Wichita, Kansas, United States
The percentage of subjects with 1 or more laboratory-confirmed RTIs through Week 16
Time frame: 16 weeks
Percent of subjects who develop one or more RTIs through week 16
Time frame: 16 weeks
The rate of RTIs/person through week 16
Time frame: 16 weeks
The rate of RTIs per person through week 24
Time frame: 24 weeks
The percentage of subjects with 1 or more laboratory-confirmed RTIs through week 24
Time frame: 24 weeks
Peak Plasma Concentration (Cmax)
Time frame: 8 weeks
Area under the plasma concentration versus time curve (AUC)
Time frame: 8 weeks
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