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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo once daily for 16 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

oral

BEZ235 once daily for 16 weeks

Group Type EXPERIMENTAL

BEZ235

Intervention Type DRUG

oral

BEZ235 twice daily for 16 weeks

Group Type EXPERIMENTAL

BEZ235

Intervention Type DRUG

oral

BEZ235 plus RAD001 once daily for 16 weeks

Group Type EXPERIMENTAL

BEZ235 plus everolimus (RAD001)

Intervention Type DRUG

Oral

Interventions

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Placebo

oral

Intervention Type OTHER

BEZ235

oral

Intervention Type DRUG

BEZ235 plus everolimus (RAD001)

Oral

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes