A Phase 2 interventional study of Placebo and BEZ235 in Respiratory Tract Infections, sponsored by Restorbio Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-16.
Sponsored by Restorbio Inc. · Phase 2, Interventional, and Prevention
Among 209 studies in Respiratory Tract Infections with a site in United States — 20 open to participants now, 27 under way, 5 of them phase 3. Respiratory Tract Infections · United States.
Among the 209 studies in Respiratory Tract Infections with a site in United States, this one is the 38th largest by enrollment of the 159 interventional ones, is one of 11 that started in 2017, is one of 31 in phase 2, reaches primary completion later than 0 of the 25 other live ones, and was the 113th registered.
751 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.
This study's enrollment of 652 is above the median of 200 across 540 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →20 of the 209 studies in Respiratory Tract Infections with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 73 Respiratory Tract Infections studies recruiting now, 34 (47%) set no upper age limit and 31 (42%) stop at 75 or younger; 34 take children under 18; 25 take healthy volunteers.
This study: 65 Years and older · all sexes · healthy volunteers too.
The full table on the hub →209 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 11 started in 2017.
Median enrollment 134 across the 159 interventional studies, 558 across the 48 observational. Of the 172 that completed or were terminated, 67 (39%) have results posted.
85 of 209 have an industry lead sponsor. The 10 most frequent:
Restorbio Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Restorbio Inc. has 3 studies filed under Respiratory Tract Infections — fewer than ten, so there is no comparison to draw.
14 of the studies in Respiratory Tract Infections with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07798648Phase 3BioNTech SEA Study of COVID-19 Vaccine(s) in Children and Adults | 2027-04-21 |
| NCT07013474Phase 3PfizerA Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised | 2027-09-28 |
| NCT06679140Phase 3PfizerA Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease | 2027-10-01 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
| NCT07251465PfizerA Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia | 2026-11-15 |
Among the 209 studies in Respiratory Tract Infections with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥ 65 and \< 85 years with one or more of the following conditions:
Exclusion Criteria:
History of in any organ system within the past 5 years except for the following:
Subjects with any one of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Placebo
Drug: BEZ235
Drug: BEZ235
Drug: BEZ235 plus everolimus (RAD001)
oral
oral
Drug page: Everolimus
Oral
The percentage of subjects with 1 or more laboratory-confirmed RTIs through Week 16
Time frame: 16 weeks
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
Plan to share: No
Ran from Nov 2017 to primary completion in May 2018, 5 months.
Of 32 phase 2 interventional studies under Respiratory Tract Infections, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 25. This study's 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Dactolisib · Everolimus
Respiratory Tract Infections →
Restorbio Inc.