NCT03373903

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
652

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

November 20, 2017

Last Update Submit

May 11, 2018

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

  • The percentage of subjects with 1 or more laboratory-confirmed RTIs through Week 16

    16 weeks

Secondary Outcomes (6)

  • Percent of subjects who develop one or more RTIs through week 16

    16 weeks

  • The rate of RTIs/person through week 16

    16 weeks

  • The rate of RTIs per person through week 24

    24 weeks

  • The percentage of subjects with 1 or more laboratory-confirmed RTIs through week 24

    24 weeks

  • Peak Plasma Concentration (Cmax)

    8 weeks

  • +1 more secondary outcomes

Study Arms (4)

Placebo once daily for 16 weeks

PLACEBO COMPARATOR
Other: Placebo

BEZ235 once daily for 16 weeks

EXPERIMENTAL
Drug: BEZ235

BEZ235 twice daily for 16 weeks

EXPERIMENTAL
Drug: BEZ235

BEZ235 plus RAD001 once daily for 16 weeks

EXPERIMENTAL
Drug: BEZ235 plus everolimus (RAD001)

Interventions

PlaceboOTHER

oral

Placebo once daily for 16 weeks
BEZ235DRUG

oral

BEZ235 once daily for 16 weeksBEZ235 twice daily for 16 weeks
BEZ235 plus everolimus (RAD001)DRUG

Oral

BEZ235 plus RAD001 once daily for 16 weeks

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heartland Research Associates

Wichita, Kansas, 67205, United States

Location

Related Publications (1)

  • Mannick JB, Teo G, Bernardo P, Quinn D, Russell K, Klickstein L, Marshall W, Shergill S. Targeting the biology of ageing with mTOR inhibitors to improve immune function in older adults: phase 2b and phase 3 randomised trials. Lancet Healthy Longev. 2021 May;2(5):e250-e262. doi: 10.1016/S2666-7568(21)00062-3. Epub 2021 May 6.

    PMID: 33977284DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

dactolisibEverolimus

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Sarb Shergill, PhD

    Restorbio Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

December 14, 2017

Study Start

November 15, 2017

Primary Completion

May 3, 2018

Study Completion

July 1, 2018

Last Updated

May 16, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)