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ARrest RESpiraTory Failure From PNEUMONIA (ARREST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193878
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : August 10, 2022
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Joseph Levitt, MD, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Pneumonia Hypoxemia Acute Respiratory Failure COVID-19 Pneumonia Drug: Inhaled budesonide and formoterol Drug: Inhaled placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: ARrest RESpiraTory Failure From PNEUMONIA (ARREST PNEUMONIA)
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : July 1, 2025
Estimated Study Completion Date : August 31, 2025


Arm Intervention/treatment
Placebo Comparator: Placebo
4 ml aerosolized 0.9% saline every 12 hours x 10 doses
Drug: Inhaled placebo
aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days
Other Name: aerosolized 0.9% saline

Active Comparator: Intervention
aerosolized formoterol (20 mcg/2 ml) and budesonide (1.0 mg/2 ml) every 12 hours x 10 doses
Drug: Inhaled budesonide and formoterol
aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days
Other Name: Pulmicort Respules (budesonide) and Perforomist (formoterol)




Primary Outcome Measures :
  1. Acute respiratory failure (ARF) [ Time Frame: within 7 days of randomization ]
    High flow nasal cannula (HFNC) 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


Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: within 60 days of randomization ]
  2. Duration of need for supplemental oxygen [ Time Frame: within 60 days of randomization ]
  3. Proportion of patients intubated for respiratory failure [ Time Frame: Within 7 days of randomization ]
  4. Oxygen failure free days to day 28 [ Time Frame: Until Day 28 ]
  5. Progression to systemic steroid therapy for pneumonia [ Time Frame: during course of the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients 18 years or older with

  1. Severe Pneumonia defined as hospitalization for acute (defined as ≤ 14 days) onset of symptoms (cough, sputum production, or dyspnea) and radiographic evidence of pneumonia by chest radiograph or CT scan AND 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.

    AND

  2. 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 24 hours from ED admission to enrolling hospital to assess for development of qualifying hypoxemia.

Exclusion Criteria:

  1. Inability to obtain consent within 24 hours of presentation to enrolling hospital (up to 12 hours allowed at transferring ED for maximum of 36 hours from presentation)
  2. Intubation (or impending intubation) prior to enrollment

    a. Patients receiving HFNC oxygen or NIV prior to enrollment are not excluded

  3. 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)
  4. Chronic systemic steroid therapy equivalent to >10 mg prednisone
  5. COVID-19 positive patients receiving > 6 mg dexamethasone (30 mg prednisone equivalent dose)
  6. Non-COVID-19 pneumonia patients receiving systemic steroid > 10 mg prednisone except for stress dose steroids for septic shock
  7. Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome
  8. Not anticipated to survive > 48 hours or not expected to require > 48 hours of hospitalization
  9. Contraindication or allergy to inhaled corticosteroids or beta-agonists
  10. 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
  11. K+ < 3.0 will be potentially eligible for enrollment after the condition has resolved
  12. Patient not committed to full support other than intubation or resuscitation (i.e., DNR/DNI status allowed)
  13. Pregnancy
  14. Incarcerated individual
  15. Physician refusal of consent to protocol
  16. Patient/surrogate refusal of consent to protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193878


Contacts
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Contact: Joseph Levitt, MD 650-213-6683 jlevitt@stanford.edu
Contact: Emir Festic, MD 9049827445 Festic.Emir@mayo.edu

Locations
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United States, Alabama
University of Alabama-Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Marie-Carmelle Elie, MD       melie@uabmc.edu   
United States, Arizona
Mayo Clinic - Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Rodrigo Cartin-Ceba, MD       cartinceba.rodrigo@mayo.edu   
Principal Investigator: Rodrigo Cartin-Ceba, MD         
University of Arizona - Main & South Campus Recruiting
Tucson, Arizona, United States, 85724
Contact: Christian Bime, MD       cbime@deptofmed.arizona.edu   
Principal Investigator: Christian Bime, MD         
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Joe Levitt, MD    650-723-6381    jlevitt@stanford.edu   
Principal Investigator: Joe Levitt, MD         
United States, Florida
University of Florida Terminated
Gainesville, Florida, United States, 32611
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Emir Festic, MD       Festic.Emir@mayo.edu   
Principal Investigator: Emir Festic, MD         
United States, Louisiana
Tulane University Not yet recruiting
New Orleans, Louisiana, United States, 70112
Contact: Josh Denson, MD       jdenson@tulane.edu   
United States, Maryland
University of Maryland Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Kami Hu, MD       khu@som.umaryland.edu   
Johns Hopkins University - Main Campus & Bayview Recruiting
Baltimore, Maryland, United States, 21205
Contact: William Checkley, MD, PhD       wcheckl1@jhmi.edu   
Principal Investigator: William Checkley, MD, PhD         
United States, Minnesota
Mayo Clinic - Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Rahul Kashyap, MBBS       Kashyap.Rahul@mayo.edu   
Principal Investigator: Ognjen Gajic, MD         
Principal Investigator: Rahul Kashyap, MBBS         
United States, New York
New York University - Langone Health Recruiting
New York, New York, United States, 10016
Contact: David Kaufman, MD       David.A.Kaufman@nyumc.org   
Principal Investigator: David Kaufman, MD         
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Nina Gentile, MD       ngentile@temple.edu   
Principal Investigator: Nina Gentile, MD         
Sponsors and Collaborators
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Joseph Levitt, MD Stanford University
Principal Investigator: Emir Festic, MD Mayo Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joseph Levitt, MD, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04193878    
Other Study ID Numbers: 53599
1UG3HL141722-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Respiratory Insufficiency
Hypoxia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Budesonide
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action