LIPS-B: Lung Injury Prevention Study With Budesonide and Beta

Phase 2 Completed 61 enrolled Mayo Clinic Beth Israel Deaconess Medical Center · collab National Center for Research Resources (NCRR) · collab Stanford University · collab University of Arizona · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

This study tested whether inhaled budesonide and formoterol were able to alleviate or prevent pulmonary injury when administered early in hospital course to the patients at risk for developing acute respiratory distress syndrome (ARDS). The FDA has approved many uses for budesonide and formoterol, including asthma and chronic obstructive pulmonary disease (COPD), but the use of these two drugs is experimental for ARDS.

Timeline

Start: 2013-07
Primary completion: 2015-07
Completion: 2015-12

Outcome

Met primary endpoint

paper The longitudinal increase in S/F was greater in the treatment group (p = 0.02) PMID 28240689 ↗

paper Categorical change in S/F improved (p = 0.01) PMID 28240689 ↗

registry analysis (superiority or other test); Budesonide and Formoterol vs Placebo; p = 0.01; Fisher Exact NCT01783821 ↗

Publications

Festic E, Carr GE, Cartin-Ceba R, Hinds RF, Banner-Goodspeed V, Bansal V, Asuni AT, Talmor D, Rajagopalan G, Frank RD, Gajic O, Matthay MA, Levitt JE. Randomized Clinical Trial of a Combination of an Inhaled Corticosteroid and Beta Agonist in Patients at Risk of Developing the Acute Respiratory Distress Syndrome. Crit Care Med. 2017 May;45(5):798-805. doi: 10.1097/CCM.0000000000002284.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	0.5 mg	Inhaled
Subject	Formoterol	Other / unclassified	20 ug	Inhaled