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

NCT03202394 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-06-25

No results posted yet for this study

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

Interventions

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".

Sponsors & Collaborators

  • BioMarck Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Brian Dickson, MD · Biomarck Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-05
Primary Completion
2020-03-30
Completion
2020-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03202394 on ClinicalTrials.gov