This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
465
aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days
aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days
University of Alabama Birmingham - Main & Highlands
Birmingham, Alabama, United States
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States
University of Arizona - Main & South Campus
Tucson, Arizona, United States
Acute Respiratory Failure (ARF)
High flow nasal cannula (HFNC \>=20L/mon O2) and/or Noninvasive ventilation (NIV) use for greater than 36 hours OR Invasive mechanical ventilation for greater than 36 hours OR Death in a patient placed on respiratory support (HFNC, NIV, ventilator) who dies before 36 hours
Time frame: within 7 days of randomization (day 0)
Hospital Length of Stay
Time frame: within 60 days of randomization (day 0)
Duration of Need for Supplemental Oxygen
Time frame: within 30 days of randomization (day 0)
Proportion of Patients Intubated for Respiratory Failure
Time frame: Within 7 days of randomization (day 0)
Oxygen Failure Free Days to Day 28
Time frame: Until Day 28
Progression to Systemic Steroid Therapy for Pneumonia
Progression defined as initiating post-randomization, open-label steroids if not already receiving dexamethasone for COVID at baseline.
Time frame: Within 7 days of randomization (day 0)
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Stanford University
Palo Alto, California, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Tulane University - Main & BUMC
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins University - Main Campus & Bayview
Baltimore, Maryland, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
...and 2 more locations