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

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