NCT03202394

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: BioMarck Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome, Adult

Interventions

Type	Name	Description
DRUG	BIO-11006	Intervention involves aerosolized delivery of either the active drug or placebo by the "Aeroneb Pro nebulizer".
DRUG	Placebo	Intervention involves aerosolized delivery of either the active drug or placebo by the "Aeroneb Pro nebulizer".

Timeline

• Start date: 2017-08-05
• Primary completion: 2020-03-30
• Completion: 2020-06-15
• First posted: 2017-06-28
• Last updated: 2020-06-25

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study