At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 61 enrolled

Drug / intervention

Budesonide +2 moredrug

Likely dose

Budesonide 0.5 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01783821

NCT01783821Phase 2Completed

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

Mayo Clinic·interventional·Posted Feb 5, 2013·Updated Sep 5, 2016

In Brief

A Phase 2 clinical trial evaluating Budesonide, Placebo, and 1 other intervention for Acute Respiratory Distress Syndrome (ARDS). Completed, enrolled 61 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAcute Respiratory Distress Syndrome (ARDS)

CountriesUnited States

CollaboratorsStanford University, Beth Israel Deaconess Medical Center, University of Arizona, National Center for Research Resources (NCRR)

Timeline

Phase 2CompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedFeb 2013

Enrollment StartJul 2013

Primary CompletionJul 2015

Study CompletionDec 2015

TodayJul 2026

First PostedFeb 5, 2013

Enrollment StartJul 1, 2013

Primary CompletionJul 1, 2015

Study CompletionDec 1, 2015

TodayJul 2, 2026

Enrollment to primary: 2 yearsPosted 13.4 years ago

Interventions

Budesonidedrug

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

Placebodrug

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

Formoteroldrug

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