Status:
ACTIVE_NOT_RECRUITING
Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly
Lead Sponsor:
Restorbio Inc.
Conditions:
Respiratory Tract Infections
Eligibility:
All Genders
65+ years
Phase:
PHASE2
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 tra...
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 combi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
652 Patients enrolled
Trial Details
Trial ID
NCT03373903
Start Date
November 15 2017
End Date
July 1 2018
Last Update
May 16 2018
Active Locations (1)
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1
Heartland Research Associates
Wichita, Kansas, United States, 67205