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

• Status: Completed
• Trial end date: 2020-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioMarck Pharmaceuticals, Ltd.

Criteria

Inclusion Criteria:

1. Has provided (or relative has) written informed consent and authorization for use and disclosure of protected health information

2. 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

3. 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)

Exclusion Criteria:

1. Age < 18 years or >75 years old

2. Greater than 48 hours since first meeting ARDS criteria per the Berlin definition of ARDS

3. Pregnant or breastfeeding (negative pregnancy test required prior to randomization for female patients of childbearing potential.)

4. Prisoner

5. Any other irreversible disease or condition for which 6 month mortality is estimated to be > 50%

6. Moderate to severe liver failure (Child Pugh Score > 12)

7. Severe chronic respiratory disease with a PaCO2 > 50 mmHg or the use of home oxygen

8. 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).

9. Major trauma in the prior 5 days

10. Lung transplant patient

11. No consent/inability to obtain consent

12. Moribund patient not expected to survive 24 hours

13. World Health Organization (WHO) Functional Class III or IV pulmonary hypertension

14. No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol

15. Currently receiving extracorporeal life support or high frequency oscillatory ventilation

16. Known hypersensitivity to BIO 11006

17. Burn victims >20% Total Body Surface Area (TBSA) or with known airway inhalation injury