Sponsor: Funded by: National Heart, Lung, and Blood Institute (NHLBI) National Institutes of Health (NIH) ; INDE Sponsor: Joseph Levitt, MD & Emir Festic, MD | Status: Recruiting
Start Date: 12/07/2022 | End Date: -
Principal Investigator(s)
Kami Windsor
Secondary Investigator(s)
Gentry Wilkerson
Description:
Study Treatments
The planned enrollment is 600 adult participants admitted through Emergency Departments of ten clinical sites. Participants will receive combined standard aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mcg/2 ml) or placebo (4 ml aerosolized 0.9% saline) twice daily for up to 5 days (or until hospital discharge), with the first dose administered within 4 hours following randomization. Blood will be collected as part of this trial at baseline, before study drug is received, and on Day 2, approximately 48 hours after receiving the first dose of study drug. Our site is hoping to enroll 10 patients.
Primary Endpoint
Acute respiratory failure (ARF) within 7 days of randomization defined as composite of:
HFNC and/or NIV use for > 36 hours, OR
Invasive mechanical ventilation or combination of invasive and n0n-invasive respiratory support (HFNC and/or NIV) for > 36 hours, OR
Death in a patient placed on respiratory support (HFNC, NIV, ventilator) who dies before 36 hours
Keywords: pneumonia,