LIPS-B: Lung Injury Prevention Study With Budesonide and Beta
Condition: Acute Respiratory Distress Syndrome (ARDS)
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
Intervention: Budesonide; Placebo; Formoterol
Intervention description: Subjects will receive the standard aerosolized dose of budesonide (0.5 mg).; Aerosolized normal saline will be prepared to mimic the intervention arm, with the quantity, appearance and timing of the doses the being the same.; Subjects will receive the standard aerosolized dose of formoterol (20 mcg) .
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute respiratory distress syndrome (ARDS)

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.
    

Eligibility 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