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Corticosteroid and Beta Agonist
Inhaled Steroid + Beta Agonist for Pneumonia (ARREST Trial)
Phase 3
Recruiting
Led By Joe Levitt, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome
COVID-19 positive patients receiving > 6 mg dexamethasone (40 mg prednisone equivalent dose) except for stress dose steroids for septic shock
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 7 days of randomization
Awards & highlights
Pivotal Trial
Summary
This trial will test if a combination of an inhaled corticosteroid and a beta agonist can prevent ARF in hospitalized patients with pneumonia and hypoxemia better than placebo.
Who is the study for?
Adults hospitalized with severe pneumonia and low oxygen levels who need supplemental oxygen or non-invasive ventilation can join. Excluded are those already intubated, on chronic steroids or inhaled medications for lung conditions, allergic to trial drugs, severely ill with a life expectancy under 48 hours, pregnant women, prisoners, and patients with certain heart issues.
What is being tested?
The study is testing if inhaling a mix of budesonide (a steroid) and formoterol (a beta agonist) can prevent acute respiratory failure in pneumonia patients compared to an inactive placebo. Participants will be randomly assigned to receive either the drug combination or placebo.
What are the potential side effects?
Inhaled budesonide may cause throat irritation, coughing, fungal infections in the mouth and hoarseness. Formoterol might lead to tremors, headaches, palpitations and muscle cramps. The combination could potentially increase these risks.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need daytime oxygen or a ventilator, not just for sleep apnea or obesity breathing issues.
Select...
I am COVID-19 positive and taking more than 6 mg of dexamethasone.
Select...
I use inhaled corticosteroids or beta-agonists for my condition.
Select...
I am allergic to or cannot use inhaled corticosteroids or beta-agonists.
Select...
I am taking more than 10 mg of prednisone daily for pneumonia, not caused by COVID-19.
Select...
I take more than 10 mg of prednisone or similar daily.
Select...
I am on a breathing machine or might need one soon.
Select...
I am expected to live more than 48 hours and not stay in the hospital for over 48 hours.
Select...
I or my surrogate have not agreed to participate in the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 7 days of randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 7 days of randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acute respiratory failure (ARF)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: InterventionActive Control1 Intervention
aerosolized formoterol (20 mcg/2 ml) and budesonide (1.0 mg/2 ml) every 12 hours x 10 doses
Group II: PlaceboPlacebo Group1 Intervention
4 ml aerosolized 0.9% saline every 12 hours x 10 doses
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,518,469 Total Patients Enrolled
6 Trials studying Pneumonia
117,967 Patients Enrolled for Pneumonia
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,023 Total Patients Enrolled
5 Trials studying Pneumonia
5,414 Patients Enrolled for Pneumonia
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,299 Total Patients Enrolled
14 Trials studying Pneumonia
22,915 Patients Enrolled for Pneumonia
Joe Levitt, MDPrincipal InvestigatorStanford University
Emir Festic, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
161 Total Patients Enrolled
Joseph Levitt, MDPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need daytime oxygen or a ventilator, not just for sleep apnea or obesity breathing issues.I am COVID-19 positive and taking more than 6 mg of dexamethasone.I use inhaled corticosteroids or beta-agonists for my condition.I am 18 or older, hospitalized with severe pneumonia, need extra oxygen, and might have an infection.I am allergic to or cannot use inhaled corticosteroids or beta-agonists.I am taking more than 10 mg of prednisone daily for pneumonia, not caused by COVID-19.I take more than 10 mg of prednisone or similar daily.You are not willing to receive full medical support except for using a breathing tube or resuscitation.I was admitted for pneumonia without severe low oxygen levels but can be observed for 24 hours.I am on a breathing machine or might need one soon.You are currently in prison.I was able to give consent within 36 hours of arriving at the hospital.I am expected to live more than 48 hours and not stay in the hospital for over 48 hours.I or my surrogate have not agreed to participate in the study.If your potassium level is less than 3.0, you may be able to join the study after it gets better.My heart condition has stabilized after experiencing a high heart rate or irregular heartbeat.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.