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


About this study

The study will answer whether inhaled budesonide and formoterol are able to alleviate or prevent pulmonary injury when administered early in hospital course to the patients at risk for developing ARDS.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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;
  • New chest radiograph performed on clinical grounds

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Emir Festic, M.D., M.S.

Closed for enrollment

Jacksonville, Fla.

Mayo Clinic principal investigator

Emir Festic, M.D., M.S.

Closed for enrollment

More information


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