Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS

NCT03202394 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: BIM-CL-005
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Respiratory Distress Syndrome, Adult

Keywords

intubation; aerosol; sepsis; edema

Outcome Measures

Primary Outcomes (1)

• 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

  28 days

Secondary Outcomes (5)

• Incidence of mortality

  End of treatment period (28 days) and end of follow up period (180 days)

• Number of Intensive Care Unit (ICU)-free days

  28 days

• Number of ventilator-free days

  28 days

• Change in oxygen saturation / fraction of inspired oxygen (S/F) ratio

  28 days

• Change in pro-inflammatory biomarkers from baseline to end of treatment

  pretreatment and end of treatment period (28 days)

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

BIO-11006 DRUG

Intervention involves aerosolized delivery of either the active drug or placebo by the "Aeroneb Pro nebulizer".

Active intervention

Placebo DRUG

Intervention involves aerosolized delivery of either the active drug or placebo by the "Aeroneb Pro nebulizer".

Also known as: Half Normal saline

Placebo intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• BioMarck Pharmaceuticals, Ltd.: lead

Study Sites (5)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University, Div of Allergy, Pulmonary, Critical Care

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Sepsis; Edema

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Brian Dickson, MD

  Biomarck Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 28, 2017
• Study Start: August 5, 2017
• Primary Completion: March 30, 2020
• Study Completion: June 15, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)