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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: Beth Israel Deaconess Medical Center; National Center for Research Resources (NCRR); Stanford University; University of Arizona
• Treatments: Budesonide; Formoterol Fumarate

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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