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

NCT01783821 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2016-09-05

Study results available
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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.

Conditions

  • Acute Respiratory Distress Syndrome (ARDS)

Interventions

DRUG

Budesonide

Subjects will receive the standard aerosolized dose of budesonide (0.5 mg).

DRUG

Placebo

Aerosolized normal saline will be prepared to mimic the intervention arm, with the quantity, appearance and timing of the doses the being the same.

DRUG

Formoterol

Subjects will receive the standard aerosolized dose of formoterol (20 mcg) .

Sponsors & Collaborators

Principal Investigators

  • Emir Festic, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-07-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01783821 on ClinicalTrials.gov