MedTrace Logo

ARrest RESpiraTory Failure From PNEUMONIA

NCT04193878 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2025-08-19

No results posted yet for this study

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.

Conditions

Interventions

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

DRUG

Inhaled placebo

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Stanford University

    lead OTHER

Principal Investigators

  • Joseph Levitt, MD · Stanford University

  • Emir Festic, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2025-07-22
Completion
2025-07-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04193878 on ClinicalTrials.gov