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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Respiratory Distress Syndrome (ARDS)

In brief

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.

Key facts

Study ID

NCT01783821

Run by

Mayo Clinic

People needed

61

Starts

2013-07-01

Expected to finish

2015-12-01

Last updated by the study team

2016-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (age > 18)
• Admitted to the hospital through the emergency department (ED)
• High risk of developing ARDS (Lung Injury Prediction Score (LIPS) greater than or equal to four)

You may not qualify if…

• Inhaled corticosteroid and/or beta agonist treatment on admission or within 7 days prior to admission (history of asthma or COPD necessitating therapy)
• Chronic pulmonary disease requiring daytime oxygen supplementation therapy
• Systemic steroid treatment on admission or within 7 days prior to admission equivalent to more than 5 mg of prednisone daily
• Inability to obtain consent within 12 hours of hospital presentation
• Acute lung injury prior to randomization
• Receiving mechanical ventilation before current hospital admission (patient who is ventilator dependent)
• Presentation believed to be purely due to heart failure without other known risk factors for ARDS
• Allergy or other contraindication to either budesonide and/or formoterol use
• Expected hospital stay and/or survival <48 hours or admission for comfort or hospice care
• Patient, surrogate or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
• Previous enrollment in this trial.
• Co-enrollment with LIPS-A trial is not allowed.
• An active enrollment in other concomitant trial will be judged on case by case basis by PIs of both trials.
• EKG and/or clinical presentation suggestive of acute coronary ischemia
• New onset cardiac arrhythmia
• Current atrial fibrillation with ventricular rate of >110/minute
• Persistent sinus tachycardia of >130/minute despite early goal directed therapy with fluids, pressors, antibiotics and supplemental oxygen
• Pregnant patients

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Stanford University — Stanford, California, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Beth Israel Medical Center — Boston, Massachusetts, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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