Respiratory Tract Infections
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Restorbio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects * Age ≥ 85 years * Age ≥ 65 and \< 85 years with one or more of the following conditions: * Asthma * Chronic Obstructive Pulmonary Disease (COPD) * Chronic bronchitis * Type 2 Diabetes Mellitus (T2DM) * Congestive Heart Failure (CHF) New York Heart Association (NYHA) functional classification I-II * Current smoker * One or more emergency room visits or hospitalizations for a RTI during the previous 12 months
Exclusion criteria
* Subjects with medically significant cardiac conditions including NYHA functional classification III-IV * Subjects with Type I diabetes mellitus. * Subjects with clinically significant underlying pulmonary disease other than asthma, GOLD Class I and II COPD or chronic bronchitis * History of malignancy in any organ system within the past 5 years except for the following: * Localized basal cell or squamous cell carcinoma of the skin, prostate cancer confined to the gland, cervical carcinoma in situ, breast cancer localized to the breast. * Subjects with any one of the following: * hemoglobin \< 10.0 g/dL for males and \< 9.0 for females * white blood cell (WBC) count \< 3,500/mm3, * neutrophil count \< 2,000/mm3 * platelet count \< 125,000/mm3 * Subjects with a history of a systemic autoimmune disease or receiving immunosuppressive therapy * Recent surgery other than minor skin surgery * Liver disease or liver injury * History or presence of impaired renal function * History of immunodeficiency diseases * Subjects with active infection * Subjects with a Mini Mental Status Examination (MMSE) score \<24 at screening. * Significant illness (based on the subject's medical history and the clinical judgement of the investigator) which has not resolved within two (2) weeks prior to initial dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects with 1 or more laboratory-confirmed RTIs through Week 16 | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent of subjects who develop one or more RTIs through week 16 | 16 weeks |
| The rate of RTIs/person through week 16 | 16 weeks |
| Area under the plasma concentration versus time curve (AUC) | 8 weeks |
| The percentage of subjects with 1 or more laboratory-confirmed RTIs through week 24 | 24 weeks |
| Peak Plasma Concentration (Cmax) | 8 weeks |
| The rate of RTIs per person through week 24 | 24 weeks |
Countries
United States
Outcome results
None listed