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PneumoniaPhase 3ARRESTNCT04193878

ARrest RESpiraTory Failure From PNEUMONIA

A Phase 3 study testing Inhaled budesonide and formoterol in people with Pneumonia and Hypoxemia, run by Stanford University at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia, Hypoxemia, Acute Respiratory Failure
What is being tested?
Inhaled budesonide and formoterol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
465 participants
Where
12 sitesUnited States
Study dates
1 Jun 2020to 22 Jul 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
  • Known current immunosuppression preventing inflammatory response, OR
  • 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.

Who cannot join

  • 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
  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins University - Main Campus & Bayview

    Baltimore, Maryland, 21205

  • University of Alabama Birmingham - Main & Highlands

    Birmingham, Alabama, 35233

  • University of Florida

    Gainesville, Florida, 32611

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Tulane University - Main & BUMC

    New Orleans, Louisiana, 70112

  • New York University - Langone Health

    New York, New York, 10016

  • Stanford University

    Palo Alto, California, 94304

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Mayo Clinic - Scottsdale

    Scottsdale, Arizona, 85259

  • University of Arizona - Main & South Campus

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: ARrest RESpiraTory Failure From PNEUMONIA (ARREST PNEUMONIA)

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.

Being tested
Inhaled budesonide and formoterol, Inhaled placebo
Medical subject headings
Pneumonia, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhaled budesonide and formoterolDrug

    Also called Pulmicort Respules (budesonide) and Perforomist (formoterol)

    aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days

  • Inhaled placeboDrug

    Also called aerosolized 0.9% saline

    aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days

Study groups in NCT04193878
Study groupRoleWhat they receive
PlaceboPlacebo comparator4 ml aerosolized 0.9% saline every 12 hours x 10 doses
Receives: Drug: Inhaled placebo
InterventionActive comparatoraerosolized formoterol (20 mcg/2 ml) and budesonide (1.0 mg/2 ml) every 12 hours x 10 doses
Receives: Drug: Inhaled budesonide and formoterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: within 7 days of randomization (day 0)

Secondary outcomes (5)

  1. Hospital Length of Stay

    Measured: within 60 days of randomization (day 0)

  2. Duration of Need for Supplemental Oxygen

    Measured: within 30 days of randomization (day 0)

  3. Proportion of Patients Intubated for Respiratory Failure

    Measured: Within 7 days of randomization (day 0)

  4. Oxygen Failure Free Days to Day 28

    Measured: Until Day 28

  5. 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.

    Measured: Within 7 days of randomization (day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start1 Jun 2020
  3. Primary completion22 Jul 2025
  4. Study completion22 Jul 2025

Why it stopped: Per DSMB's review of interim analysis, the study has reached the pre-specified futility criteria

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
465 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04193878
Sponsor's protocol ID
53599
Other IDs
1UG3HL141722-01A1
Acronym
ARREST
Status last verified
Jul 2026
First submitted
3 Dec 2019
Last updated
6 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Levitt JE, Festic E, Desai M, Hedlin H, Mahaffey KW, Rogers AJ, Gajic O, Matthay MA; ARREST Pneumonia Clinical Trial Investigators. The ARREST Pneumonia Clinical Trial. Rationale and Design. Ann Am Thorac Soc. 2021 Apr;18(4):698-708. doi: 10.1513/AnnalsATS.202009-1115SD.

    PubMed 33493423

  • Nicolau DV, Bafadhel M. Inhaled corticosteroids in virus pandemics: a treatment for COVID-19? Lancet Respir Med. 2020 Sep;8(9):846-847. doi: 10.1016/S2213-2600(20)30314-3. Epub 2020 Jul 30. No abstract available.

    PubMed 32738928

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inhaled budesonide and formoterol in people with Pneumonia and Hypoxemia, run by Stanford University at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Respiratory Failure (ARF) (time frame: within 7 days of randomization (day 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04193878, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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ARrest RESpiraTory Failure From PNEUMONIA | AzTrials