ARest RESpiratory failure due to PNEUMONIA

This is an AI generated image of a lung MRI

This NIH-funded study tests whether inhaled budesonide and formoterol can prevent acute respiratory failure (ARF). Though FDA-approved for asthma and COPD, their use for ARF is investigational. The drugs are considered safe, but their effectiveness for ARF prevention is unknown.

Study Status

Enrollment Period

Eligibility Criteria

Accepts Healthy Volunteers
No

Contact Information

tccr@tulane.edu
Tulane Center for Clinical Research

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Who Qualifies for this Study?

National Institute of Health (NIH) and National Heart, Lung, & Blood Institute (NHLBI)

Protocol: WCG IRB Protocol #20193072 

The main purpose of this study, funded by The National Institutes of Health (NIH), is to test if treatment with inhaled medications, budesonide and formoterol, lower your risk of ARF. A previous smaller study that we performed in patients with pneumonia, some of which had viral pneumonia, showed that these medications improve oxygen levels. However, the drugs involved in this study, budesonide and formoterol, are considered investigational for preventing ARF. The Food and Drug Administration (FDA) has not approved budesonide and formoterol specifically for helping to reduce ARF. The FDA has approved many uses for budesonide and formoterol, including for asthma and chronic obstructive pulmonary disease (COPD), but not for the way we are using them in this study. We are conducting this study to see if budesonide and formoterol can help prevent ARF. We do not know for sure if they are useful for prevention of ARF. However, these medications are considered relatively safe and are often used for long periods of time, even life-long, in patients with asthma or COPD. 

Study Overview

This study, funded by the National Institutes of Health (NIH), is looking at whether two common inhaled medications—budesonide and formoterol—can help prevent serious breathing problems called acute respiratory failure (ARF). These medications are already approved by the FDA to treat asthma and COPD (a chronic lung disease), and they’ve been used safely by many people for years.

However, using them to prevent ARF is new and hasn’t been officially approved yet. A smaller earlier study showed that these medicines might help improve oxygen levels in people with pneumonia, but we don’t yet know for sure if they can prevent ARF. That’s why we’re doing this research—to find out if they work for this purpose and could help more people breathe easier and avoid serious complications.

Conditions / Diseases

Pneumonia
Respiratory Failure

Department / Organizations

Tulane Center for Clinical Research (TCCR)

Principal Investigator

ClinicalTrials.gov

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