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