Evidence map›Paper›PMID 28240689›Full record

Trial reportCritical care medicine2017

Randomized Clinical Trial of a Combination of an Inhaled Corticosteroid and Beta Agonist in Patients at Risk of Developing the Acute Respiratory Distress Syndrome.

Emir Festic, Gordon E Carr, Rodrigo Cartin-Ceba, Richard F Hinds, Valerie Banner-Goodspeed, Vikas Bansal, Adijat T Asuni, Daniel Talmor, Govindarajan Rajagopalan, Ryan D Frank and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Critical care medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01783821 (LIPS-B), which is not on this map. Cited by 56 papers.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed
6.5field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01783821 phase2completednot on this map

LIPS-B: Lung Injury Prevention Study With Budesonide and Beta Agonist (Formoterol)

TypeinterventionalSponsorMayo ClinicRan2013 to 2015Enrolled61ConditionsAcute Respiratory Distress Syndrome (ARDS)ArmsBudesonide, Placebo, Formoterol
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 90 citations in OpenAlex.

  1. Trial
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  17. Black representation in critical care randomized controlled trials: a meta-epidemiological study.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2023
    Review
  18. Article
  19. Review
  20. Pulmonary drug delivery for acute respiratory distress syndrome.Pulmonary pharmacology & therapeutics · 2023
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 1 country.

Emir Festic1Department of Critical Care, Mayo Clinic, Jacksonville, FL. 2Division of Pulmonary and Critical Care, Department of Medicine, University of Arizona, Tucson, AZ. 3Department of Critical Care, Mayo Clinic, Scottsdale, AZ. 4Division of Pulmonary and Critical Care, Department of Medicine, Mayo Clinic, Rochester, MN. 5Department of Anesthesia, Beth Israel Deaconess Medical Center, Boston, MA. 6Division of Pulmonary and Critical Care, Department of Medicine, Stanford University, Stanford, CA. 7Department of Immunology, Mayo Clinic, Rochester, MN. 8Department of Health-Science Research/Biostatistics, Mayo Clinic, Jacksonville, FL. 9Departments of Medicine and Anesthesia, Cardiovascular Research Institute, University of California, San Francisco, CA.
Gordon E Carr
Rodrigo Cartin-Ceba
Richard F Hinds
Valerie Banner-Goodspeed
Vikas Bansal
Adijat T Asuni
Daniel Talmor
Govindarajan Rajagopalan
Ryan D Frank
Ognjen Gajic
Michael A Matthay
Joseph E Levitt
Mayo Clinic in Arizona · USBeth Israel Deaconess Medical Center · USMayo Clinic in Florida · USStanford University · USUniversity of California, San Francisco · US

Funding

Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
Mayo Clinic Center for Translational Science ActivitiesKL2TR000136 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$6.6M
Early Acute Lung Injury: Prospective Evaluation Prior to Respiratory FailureK23HL091334 · NHLBI · STANFORD UNIVERSITY · PI LEVITT, JOSEPH ERIC · 2009 to 2013
$671k
NCATS NIH HHS KL2 TR000136NCATS NIH HHS UL1 TR000135NHLBI NIH HHS K23 HL091334
6 · The paper itself

Abstract

objectivesEffective pharmacologic treatments directly targeting lung injury in patients with the acute respiratory distress syndrome are lacking. Early treatment with inhaled corticosteroids and beta agonists may reduce progression to acute respiratory distress syndrome by reducing lung inflammation and enhancing alveolar fluid clearance.

designDouble-blind, randomized clinical trial (ClinicalTrials.gov: NCT01783821). The primary outcome was longitudinal change in oxygen saturation divided by the FIO2 (S/F) through day 5. We also analyzed categorical change in S/F by greater than 20%. Other outcomes included need for mechanical ventilation and development of acute respiratory distress syndrome.

settingFive academic centers in the United States. PATIENTS: Adult patients admitted through the emergency department at risk for acute respiratory distress syndrome.

interventionsAerosolized budesonide/formoterol versus placebo bid for up to 5 days. MEASUREMENTS AND MAIN

resultsSixty-one patients were enrolled from September 3, 2013, to June 9, 2015. Median time from presentation to first study drug was less than 9 hours. More patients in the control group had shock at enrollment (14 vs 3 patients). The longitudinal increase in S/F was greater in the treatment group (p = 0.02) and independent of shock (p = 0.04). Categorical change in S/F improved (p = 0.01) but not after adjustment for shock (p = 0.15). More patients in the placebo group developed acute respiratory distress syndrome (7 vs 0) and required mechanical ventilation (53% vs 21%).

conclusionsEarly treatment with inhaled budesonide/formoterol in patients at risk for acute respiratory distress syndrome is feasible and improved oxygenation as assessed by S/F. These results support further study to test the efficacy of inhaled corticosteroids and beta agonists for prevention of acute respiratory distress syndrome.

Indexed as

Academic Medical CentersAdministration, InhalationAdrenal Cortex HormonesAdrenergic beta-AgonistsAgedAged, 80 and overBiomarkersBudesonide, Formoterol Fumarate Drug CombinationDouble-Blind MethodDrug Therapy, CombinationFemaleHumansHypoxiaMaleMiddle AgedOxygenAdrenal Cortex HormonesAdrenergic beta-AgonistsBiomarkersBudesonide, Formoterol Fumarate Drug CombinationOxygen

Identifiers

PMID28240689
PMCPMC5392150
OpenAlexW2589468479

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.