Trial Search Results
LIPS-B: Lung Injury Prevention Study With Budesonide and Beta
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.
Stanford is currently accepting patients for this trial.
Collaborator: National Center for Research Resources (NCRR)
- Drug: Budesonide
- Drug: Placebo
- Drug: Formoterol
- 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)
- 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
- 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
- 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study