Respiratory Tract InfectionsPhase 2NCT03373903
Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly
A Phase 2 study testing BEZ235 and BEZ235 plus everolimus (RAD001) in people with Respiratory Tract Infections, run by Restorbio Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- BEZ235 and BEZ235 plus everolimus (RAD001)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 652 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to Jul 2018
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Heartland Research Associates
Wichita, Kansas, 67205
About this study
Official title: A Multicenter, Dose-finding Study to Determine if Oral BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in Elderly Subjects
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.
Read the 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.
- Conditions
- Respiratory Tract Infections
- Being tested
- Placebo, BEZ235, BEZ235 plus everolimus (RAD001)
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
oral
BEZ235Drug
oral
BEZ235 plus everolimus (RAD001)Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Placebo once daily for 16 weeks | Placebo comparator | Not described Receives: Other: Placebo |
| BEZ235 once daily for 16 weeks | Experimental | Not described Receives: Drug: BEZ235 |
| BEZ235 twice daily for 16 weeks | Experimental | Not described Receives: Drug: BEZ235 |
| BEZ235 plus RAD001 once daily for 16 weeks | Experimental | Not described Receives: Drug: BEZ235 plus everolimus (RAD001) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects with 1 or more laboratory-confirmed RTIs through Week 16
Measured: 16 weeks
Secondary outcomes (6)
Percent of subjects who develop one or more RTIs through week 16
Measured: 16 weeks
The rate of RTIs/person through week 16
Measured: 16 weeks
The rate of RTIs per person through week 24
Measured: 24 weeks
The percentage of subjects with 1 or more laboratory-confirmed RTIs through week 24
Measured: 24 weeks
Peak Plasma Concentration (Cmax)
Measured: 8 weeks
Area under the plasma concentration versus time curve (AUC)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start15 Nov 2017
- Primary completion3 May 2018
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restorbio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarb Shergill, PhD, Study director, Restorbio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373903
- Sponsor's protocol ID
- RTB-BEZ235-202
- Status last verified
- May 2018
- First submitted
- 20 Nov 2017
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33977284
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Dose-finding Study to Determine if Oral BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in Elderly Subjects
- ClinicalTrials.gov ID
- NCT03373903
- Acronym / sponsor ID
- RTB-BEZ235-202
- Conditions
- Respiratory Tract Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 652 participants (actual)
- Lead sponsor
- Restorbio Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- Jul 2018 (estimated)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Male and female subjects
- Age ≥ 85 years
- Age ≥ 65 and < 85 years with one or more of the following conditions:
Key exclusion criteria (18 listed)
- 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:
- Subjects with any one of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebooral | Other | Placebo once daily for 16 weeks |
| BEZ235oral | Drug | BEZ235 once daily for 16 weeks, BEZ235 twice daily for 16 weeks |
| BEZ235 plus everolimus (RAD001)Oral | Drug | BEZ235 plus RAD001 once daily for 16 weeks |
Primary outcome
The percentage of subjects with 1 or more laboratory-confirmed RTIs through Week 16
Time frame: 16 weeks
6 secondary outcomes
Percent of subjects who develop one or more RTIs through week 16
Time frame: 16 weeks
The rate of RTIs/person through week 16
Time frame: 16 weeks
The rate of RTIs per person through week 24
Time frame: 24 weeks
The percentage of subjects with 1 or more laboratory-confirmed RTIs through week 24
Time frame: 24 weeks
Peak Plasma Concentration (Cmax)
Time frame: 8 weeks
Area under the plasma concentration versus time curve (AUC)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Derived from this study: PubMed 33977284Mannick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarb Shergill, PhD study director
Restorbio Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BEZ235 and BEZ235 plus everolimus (RAD001) in people with Respiratory Tract Infections, run by Restorbio Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects with 1 or more laboratory-confirmed RTIs through Week 16 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.