Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS
Condition: Respiratory Distress Syndrome, Adult
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): BIO-11006; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intervention involves aerosolized delivery of either the active drug or placebo by the "Aeroneb Pro nebulizer".; Intervention involves aerosolized delivery of either the active drug or placebo by the "Aeroneb Pro nebulizer".
Other intervention name(s): Half Normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intubation; aerosol; sepsis; edema