Respiratory Distress Syndrome, AdultPhase 2NCT03202394
Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS
A Phase 2 study testing BIO-11006 in people with Respiratory Distress Syndrome, Adult, run by BioMarck Pharmaceuticals, Ltd. at 5 sites in United States.
Trial summary
This Phase IIa pilot study is a placebo controlled, multicenter study to evaluate safety and efficacy of aerosolized BIO-11006 Inhalation Solution in ARDS patients. The subjects will be randomized 1:1 to either BIO-11006 125 mg twice daily plus standard of care or placebo plus standard of care. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- BIO-11006
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Aug 2017to 15 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has provided (or relative has) written informed consent and authorization for use and disclosure of protected health information
- Has a clinical diagnosis of sepsis or septic shock defined as:
- Known or suspected infection
- Systemic inflammatory response syndrome (SIRS), defined as meeting at least 2 of the following 3 criteria for a systemic inflammatory response:
- White blood cell count >12,000 or <4,000 or >10% band forms
- Body temperature >38°C (any route) or <36°C (by core temperatures only: indwelling catheter, esophageal, rectal)
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- Heart rate >90 beats/min or receiving medications that slow heart rate or pace rhythm
- Enrollment must occur within 48 hours of first meeting ARDS criteria per the Berlin definition of ARDS (ARDS Task Force 2012) and no more than 72 hours from the initiation of mechanical ventilation. (The bilateral opacities, respiratory failure, and decreased P/F ratio must all be present within a 24 hour time period of one another.):
- Lung injury of acute onset, within 1 week of an apparent clinical insult, with progression of respiratory symptoms
- Bilateral opacities on chest imaging not fully explained by effusions, lobar/lung collapse, or nodules.
- Respiratory failure not fully explained by cardiac failure or fluid overload. (Need objective assessment (e.g. echocardiography) to exclude hydrostatic edema if no risk factor present.)
- Decreased arterial partial pressure of oxygen (PaO2)/ fraction of inspired oxygen (FIO2) ratio while on a minimum Positive End Expiratory Pressure (PEEP) of 5 cm water (H2O):
- Moderate ARDS: 101 to 200 mmHg (≤ 26.6 kPa)
- Severe ARDS: ≤ 100 mmHg (≤ 13.3 kPa)
Who cannot join
- Age < 18 years or >75 years old
- Greater than 48 hours since first meeting ARDS criteria per the Berlin definition of ARDS
- Pregnant or breastfeeding (negative pregnancy test required prior to randomization for female patients of childbearing potential.)
- Prisoner
- Any other irreversible disease or condition for which 6 month mortality is estimated to be > 50%
- Moderate to severe liver failure (Child Pugh Score > 12)
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- Severe chronic respiratory disease with a PaCO2 > 50 mmHg or the use of home oxygen
- Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest).
- Major trauma in the prior 5 days
- Lung transplant patient
- No consent/inability to obtain consent
- Moribund patient not expected to survive 24 hours
- World Health Organization (WHO) Functional Class III or IV pulmonary hypertension
- No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol
- Currently receiving extracorporeal life support or high frequency oscillatory ventilation
- Known hypersensitivity to BIO 11006
- Burn victims >20% Total Body Surface Area (TBSA) or with known airway inhalation injury
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
University of Chicago Medicine
Chicago, Illinois, 60637
Vanderbilt University, Div of Allergy, Pulmonary, Critical Care
Nashville, Tennessee, 37232
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase IIa, Placebo Controlled, Multicenter Pilot Study to Evaluate the Safety and Efficacy of BIO-11006 Inhalation Solution in Patients With Acute Respiratory Distress Syndrome
This Phase IIa pilot study is a placebo controlled, multicenter study to evaluate safety and efficacy of aerosolized BIO-11006 Inhalation Solution in ARDS patients. The subjects will be randomized 1:1 to either BIO-11006 125 mg twice daily plus standard of care or placebo plus standard of care. The treatment will continue for up to 28 days. The study will enroll up to 40 adult ARDS patients in up to eight sites within USA.
Read the detailed description
This is a randomized, double blind, placebo controlled, parallel-group Phase IIa pilot study of aerosolized BIO 11006 in patients with sepsis-induced acute respiratory distress syndrome (ARDS). All patients enrolled in the study will be ventilated. To be eligible for enrollment, patients must be adults who have sepsis-induced ARDS within 48 hours prior to enrollment, require intubation, and exhibit bilateral infiltrates consistent with pulmonary edema on the frontal chest radiograph within 48 hours of enrollment. Patients will be randomized in a 1:1 ratio to either BIO-11006 125 mg twice daily (BID) plus standard of care ventilation or placebo (half normal saline [HNS]) BID plus standard of care ventilation. Patients randomized to receive BIO-11006 or placebo will start dosing at the time of ventilation and continue for up to 28 days or length of ventilation (if shorter). Patients in both groups will receive best available standard of care treatment, including low-volume mechanical ventilation as indicated by clinical judgment and patient response. The maximum duration of treatment will be 30 days.
The primary objective of this study is to evaluate the safety and efficacy of aerosolized BIO-11006 at a dose of 125 mg BID in ventilated patients who have ARDS. Safety is the primary endpoint in this study and will be monitored by adverse event reporting, oxygenation, mortality, vital signs, ventilator-free days, and ICU-free days.
This study will enroll up to 40 adult patients with ARDS induced by sepsis who first met the Berlin Criteria for ARDS within 48 hours of enrollment, and who require intubation and exhibit bilateral opacities consistent with pulmonary edema on frontal chest radiograph within 48 hours of enrollment.
BIO 11006 Inhalation Solution drug product is formulated at a dosage strength of 41.67 mg/mL (125 mg/3 mL) as an aqueous solution containing sodium chloride and is intended for aerosol administration by the "Aeroneb Pro®" nebulizer to patients randomized to active treatment.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- BIO-11006, Placebo
- Keywords
- intubation, aerosol, sepsis, edema
- Medical subject headings
- Respiratory Distress Syndrome, Sepsis, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIO-11006Drug
Intervention involves aerosolized delivery of either the active drug or placebo by the "Aeroneb Pro nebulizer".
PlaceboDrug
Also called Half Normal saline
Intervention involves aerosolized delivery of either the active drug or placebo by the "Aeroneb Pro nebulizer".
| Study group | Role | What they receive |
|---|---|---|
| Active intervention | Active comparator | Patients will be randomized in a 1:1 ratio to either aerosolized BIO-11006 (125mg in 3mL half normal saline) intervention twice daily plus ventilation for up to 28 days or placebo. Receives: Drug: BIO-11006 |
| Placebo intervention | Placebo comparator | Patients will be randomized in a 1:1 ratio to either aerosolized placebo (3mL half normal saline) intervention twice daily plus ventilation for up to 28 days or active drug. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Assessment of frequency, type, severity, and duration of treatment-emergent Adverse Events (AE) daily during 28 day treatment period, including clinically significant laboratory abnormalities
Measured: 28 days
Secondary outcomes (5)
Incidence of mortality
Mortality will be assessed daily during treatment for 28 days and at day 180 after enrollment.
Measured: End of treatment period (28 days) and end of follow up period (180 days)
Number of Intensive Care Unit (ICU)-free days
Number of days not in the ICU assessed daily during the 28 day treatment period.
Measured: 28 days
Number of ventilator-free days
Number of days off the ventilator assessed daily during 28 day treatment
Measured: 28 days
Change in oxygen saturation / fraction of inspired oxygen (S/F) ratio
Change in theS/F ratio assessed daily during the 28 day treatment period
Measured: 28 days
Change in pro-inflammatory biomarkers from baseline to end of treatment
ARDS associated biomarkers will be measured in plasma
Measured: pretreatment and end of treatment period (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start5 Aug 2017
- Primary completion30 Mar 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 ratio to either BIO 11006 125 mg twice daily (intervention) plus standard of care ventilation or placebo BID plus standard of care ventilation. Patients randomized to receive BIO 11006 or placebo will start dosing at the time of ventilation and continue for up to 30 days or length of ventilation (if shorter).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMarck Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Dickson, MD, Study chair, Biomarck Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202394
- Sponsor's protocol ID
- BIM-CL-005
- Status last verified
- Jun 2020
- First submitted
- 20 Jun 2017
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Placebo Controlled, Multicenter Pilot Study to Evaluate the Safety and Efficacy of BIO-11006 Inhalation Solution in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03202394
- Acronym / sponsor ID
- BIM-CL-005
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- intubation, aerosol, sepsis, edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- BioMarck Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 28 Jun 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.
This Phase IIa pilot study is a placebo controlled, multicenter study to evaluate safety and efficacy of aerosolized BIO-11006 Inhalation Solution in ARDS patients. The subjects will be randomized 1:1 to either BIO-11006 125 mg twice daily plus standard of care or placebo plus standard of care. The treatment will continue for up to 28 days. The study will enroll up to 40 adult ARDS patients in up to eight sites within USA.
Detailed description
This is a randomized, double blind, placebo controlled, parallel-group Phase IIa pilot study of aerosolized BIO 11006 in patients with sepsis-induced acute respiratory distress syndrome (ARDS). All patients enrolled in the study will be ventilated. To be eligible for enrollment, patients must be adults who have sepsis-induced ARDS within 48 hours prior to enrollment, require intubation, and exhibit bilateral infiltrates consistent with pulmonary edema on the frontal chest radiograph within 48 hours of enrollment. Patients will be randomized in a 1:1 ratio to either BIO-11006 125 mg twice daily (BID) plus standard of care ventilation or placebo (half normal saline [HNS]) BID plus standard of care ventilation. Patients randomized to receive BIO-11006 or placebo will start dosing at the time of ventilation and continue for up to 28 days or length of ventilation (if shorter). Patients in both groups will receive best available standard of care treatment, including low-volume mechanical ventilation as indicated by clinical judgment and patient response. The maximum duration of treatment will be 30 days.
The primary objective of this study is to evaluate the safety and efficacy of aerosolized BIO-11006 at a dose of 125 mg BID in ventilated patients who have ARDS. Safety is the primary endpoint in this study and will be monitored by adverse event reporting, oxygenation, mortality, vital signs, ventilator-free days, and ICU-free days.
This study will enroll up to 40 adult patients with ARDS induced by sepsis who first met the Berlin Criteria for ARDS within 48 hours of enrollment, and who require intubation and exhibit bilateral opacities consistent with pulmonary edema on frontal chest radiograph within 48 hours of enrollment.
BIO 11006 Inhalation Solution drug product is formulated at a dosage strength of 41.67 mg/mL (125 mg/3 mL) as an aqueous solution containing sodium chloride and is intended for aerosol administration by the "Aeroneb Pro®" nebulizer to patients randomized to active treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 ratio to either BIO 11006 125 mg twice daily (intervention) plus standard of care ventilation or placebo BID plus standard of care ventilation. Patients randomized to receive BIO 11006 or placebo will start dosing at the time of ventilation and continue for up to 30 days or length of ventilation (if shorter).
| Arm | Type | Receives |
|---|---|---|
| Active intervention | Active comparator | Drug: BIO-11006Patients will be randomized in a 1:1 ratio to either aerosolized BIO-11006 (125mg in 3mL half normal saline) intervention twice daily plus ventilation for up to 28 days or placebo. |
| Placebo intervention | Placebo comparator | Drug: PlaceboPatients will be randomized in a 1:1 ratio to either aerosolized placebo (3mL half normal saline) intervention twice daily plus ventilation for up to 28 days or active drug. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Has provided (or relative has) written informed consent and authorization for use and disclosure of protected health information
- Has a clinical diagnosis of sepsis or septic shock defined as:
- Enrollment must occur within 48 hours of first meeting ARDS criteria per the Berlin definition of ARDS (ARDS Task Force 2012) and no more than 72 hours from the initiation of mechanical ventilation. (The bilateral opacities, respiratory failure, and decreased P/F ratio must all be present within a 24 hour time period of one another.):
Key exclusion criteria (17 listed)
- Age < 18 years or >75 years old
- Greater than 48 hours since first meeting ARDS criteria per the Berlin definition of ARDS
- Pregnant or breastfeeding (negative pregnancy test required prior to randomization for female patients of childbearing potential.)
- Prisoner
- Any other irreversible disease or condition for which 6 month mortality is estimated to be > 50%
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 |
|---|---|---|
| BIO-11006Intervention involves aerosolized delivery of either the active drug or placebo by the "Aeroneb Pro nebulizer". | Drug | Active intervention |
| PlaceboAlso: Half Normal salineIntervention involves aerosolized delivery of either the active drug or placebo by the "Aeroneb Pro nebulizer". | Drug | Placebo intervention |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 28 days
Assessment of frequency, type, severity, and duration of treatment-emergent Adverse Events (AE) daily during 28 day treatment period, including clinically significant laboratory abnormalities
5 secondary outcomes
Incidence of mortality
Time frame: End of treatment period (28 days) and end of follow up period (180 days)
Number of Intensive Care Unit (ICU)-free days
Time frame: 28 days
Number of ventilator-free days
Time frame: 28 days
Change in oxygen saturation / fraction of inspired oxygen (S/F) ratio
Time frame: 28 days
Change in pro-inflammatory biomarkers from baseline to end of treatment
Time frame: pretreatment and end of treatment period (28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- 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.
Brian Dickson, MD study chair
Biomarck Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIO-11006 in people with Respiratory Distress Syndrome, Adult, run by BioMarck Pharmaceuticals, Ltd. at 5 sites 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 14 inclusion and 17 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: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment-emergent adverse events (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2020.