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Clinical Trials in the USA / NCT03373903
Active, not recruiting Phase 2

Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly

NCT03373903 · tracked via the Priya Life Science USA tracker
Sponsor
Restorbio Inc
Phase
Phase 2
Started
2017-11-15
Last updated
2018-05-16

Condition(s) studied

Respiratory Tract Infections

Investigational drug(s) / intervention(s)

PlaceboBEZ235 →BEZ235 plus everolimus (RAD001)All Dactolisib trials (2) →All Everolimus trials (53) →

Placebo: oral

BEZ235: oral

BEZ235 plus everolimus (RAD001): Oral

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Heartland Research Associates Wichita Kansas

More Restorbio Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03373903 on ClinicalTrials.gov ↗ ← All trials in the USA