Can a simple inhaled combo keep pneumonia patients off ventilators?
NCT ID NCT04193878
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether an inhaled combination of budesonide (a corticosteroid) and formoterol (a bronchodilator) can prevent acute respiratory failure in hospitalized adults with pneumonia and low blood oxygen levels. Participants receive either the active treatment or a saline placebo twice daily for up to five days. The study aims to see if this approach reduces the need for high-flow oxygen, noninvasive ventilation, or mechanical ventilation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Inhaled budesonide and formoterol
- What this could lead to
- If effective, this treatment could reduce the need for breathing support and lower the risk of respiratory failure in hospitalized pneumonia patients.
- What could go wrong
- The trial is still in progress, and results are not yet known. The treatment may not prove more effective than placebo, and there are potential side effects from inhaled steroids and bronchodilators.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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465 people
The number who actually took part.
- Started
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Jun 2020
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients 18 years or older with Severe pneumonia defined as: 1\. Hospitalization for acute (defined as ≤ 14 days) onset of symptoms (cough, sputum production, or dyspnea), AND 2. Radiographic evidence of pneumonia by chest radiograph or CT scan, AND 3. One of the following: 1. Evidence of systemic inflammation (temperature \< 35◦C or \> 38◦C OR WBC \> or \< upper or lower limits for site OR procalcitonin \> 0.5 mcg/L), OR 2. Known current immunosuppression preventing inflammatory response, OR 3. High clinical suspicion of pneumonia with microbiologic confirmation of infection. Microbiologic confirmation will include a positive nasal swab for a known respiratory virus; a sputum culture growing a likely pathogenic organism plus moderate or greater WBCs (not required for immunocompromised patients); or a positive blood culture with a likely pathogenic organism - e.g., ¼ vials with S. Epidermidis would NOT qualify) AND Hypoxemia defined as new requirement for daytime supplemental oxygen with SpO2 \< 92% on room air, ≤ 96% on ≥ 2 L/min oxygen, or \> 6L/min or non-invasive ventilation regardless of SpO2 at enrollment. Patients admitted with pneumonia but not meeting criteria for hypoxemia will be followed for up to 48 hours from ED admission to enrolling hospital to assess for development of qualifying hypoxemia. Exclusion Criteria: * Inability to randomize within 48 hours of presentation to enrolling hospital (randomization beyond 24 hours will be limited to patients with persistent hypoxemia defined by an SpO2 \< 97% while on \> 3L/min O2) * Intubation (or impending intubation) prior to enrollment a. Patients receiving HFNC oxygen or NIV prior to enrollment are not excluded * A condition requiring inhaled corticosteroids or beta-agonists (patients receiving inhaled beta-agonists in the ED without an established indication will be eligible if treating clinician is willing to discontinue subsequent treatments) * Chronic systemic steroid therapy equivalent to \>10 mg prednisone * COVID-19 positive patients receiving \> 6 mg dexamethasone (40 mg prednisone equivalent dose) except for stress dose steroids for septic shock * Non-COVID-19 pneumonia patients receiving systemic steroid \> 10 mg prednisone except for stress dose steroids for septic shock * Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome * Not anticipated to survive \> 48 hours or not expected to require \> 48 hours of hospitalization * Contraindication or allergy to inhaled corticosteroids or beta-agonists * Patients with heart rate \> 130 bpm, ventricular tachycardia or new supraventricular tachycardia within last 4 hours will be potentially eligible for enrollment after the condition has resolved * Patients with K+ \< 3.0 will be potentially eligible for enrollment after the condition has resolved * Patient not committed to full support other than intubation or resuscitation (i.e., DNR/DNI status allowed) * Pregnancy * Incarcerated individual * Physician refusal of consent to protocol * Patient/surrogate refusal of consent to protocol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Johns Hopkins University - Main Campus & Bayview
Baltimore, Maryland, 21205, United States
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Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
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Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
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Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259, United States
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New York University - Langone Health
New York, New York, 10016, United States
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Stanford University
Palo Alto, California, 94304, United States
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Temple University
Philadelphia, Pennsylvania, 19140, United States
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Tulane University - Main & BUMC
New Orleans, Louisiana, 70112, United States
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University of Alabama Birmingham - Main & Highlands
Birmingham, Alabama, 35233, United States
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University of Arizona - Main & South Campus
Tucson, Arizona, 85724, United States
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University of Florida
Gainesville, Florida, 32611, United States
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University of Maryland
Baltimore, Maryland, 21201, United States
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