Study determining whether treatment of elderly subjects with oral BEZ235 alone or in combination with RAD001 decrease the incidence of respiratory tract infections
- Conditions
- Respiratory Tract InfectionsRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12617000468325
- Lead Sponsor
- resTORbio Inc.
- Brief Summary
Older adults are at increased risk of viral respiratory tract infections due to declining immune function that occurs with aging. This risk is further increased in those who are over 85 years of age, or those over 65 years who also have asthma, type 2 diabetes mellitus, COPD, or an active habit of smoking tobacco. A prior study had observed that daily treatment with drugs that inhibit the TORC1 protein may reduce the rate of infections, including respiratory infections, in older adults. This study was a randomized, double-blind, placebo-controlled trial in 652 older adults at increased risk of viral respiratory tract infections. The purpose of the study was to find a dose of a TORC1 inhibitor called BEZ235 (now renamed as RTB101) alone or in combination with a TORC1 inhibitor called everolimus that was both well tolerated and reduced the incidence of laboratory-confirmed respiratory tract infections in at risk older adults. At risk older adults included people 85 years of age or older, or people 65 years of age and older who also had asthma, type 2 diabetes mellitus, COPD, or an active habit of smoking tobacco. The study was conducted in two parts. In the first part, conducted during winter cold and flu season in New Zealand, participants were randomized to one of three treatment groups: BEZ235 5 mg once daily, BEZ235 10 mg once daily, or placebo. In the second part, conducted during winter cold and flu season in the United States, participants were randomized to one of four
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 179
1. Male and female subjects without unstable medical conditions as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening and
A. Age 85 years and above
or
B. Age 65 years and above with one or more of the following conditions:
a. Current smoker
b. COPD Gold Class I or II (post bronchodilator FEV1/FVC < 0.70 and FEV1 less than or equal to 50% predicted)
c. Asthma
d. Chronic bronchitis
e. CHF New York Heart Association functional classification I-II
f. T2DM
g. One or more emergency room visits or hospitalizations for a RTI during the previous 12 months
2. Females must be post-menopausal
3. Sexually active male subjects with a partner of child-bearing potential must be willing to wear a condom while on study drug and for 1 week after stopping study drug, and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
4. At screening and baseline, vital signs (systolic and diastolic blood pressure, pulse rate and respiratory rate) will be assessed in a sitting position after the subject has rested for at least three (3) minutes. Sitting vital signs should be within the following ranges:
a. oral body temperature between 35.0-37.5 degrees Celsius
b. systolic blood pressure, 90-160 mm Hg
c. diastolic blood pressure, 50-95 mm Hg
d. pulse rate, 40 - 95 bpm
5. Subjects must weigh at least 40 kg
1. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to Screening
2. New York Heart Association functional classification III-IV congestive heart failure
3. Subjects with Type I diabetes mellitus
4. Subjects with clinically significant underlying pulmonary disease other than asthma, GOLD Class I and II COPD or chronic bronchitis
5. Subjects with a history of a systemic autoimmune disease or receiving immunosuppressive therapy including prednisone > 10 mg po daily
6. Any history of coagulopathy or medical condition requiring long-term anti-coagulation (low-dose aspirin treatment or equivalent is allowed)
The protocol has the full list of exclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method