Clinical trial NCT01783821: LIPS-B: Lung Injury Prevention Study With Budesonide and Beta
Official title: LIPS-B: Lung Injury Prevention Study With Budesonide and Beta Agonist (Formoterol)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Keywords: Acute respiratory distress syndrome (ARDS)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Beth Israel Deaconess Medical Center
name: University of Arizona
name: National Center for Research Resources (NCRR)
First posted: 2013-02-05
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Subjects were randomized to either placebo or combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 calendar days for a total of 10 doses or until hospital discharge or death. Local hospital pharmacies prepared identical appearing solutions and drug was delivered by respiratory therapists blinded to randomization by using standard jet nebulizers that produce aerosol particle size within the respirable range (\<5.5 microns). The first dose was administered within 4 hours after randomization.

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

Primary outcomes:
measure: Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio
timeFrame: baseline to day 5 after the first treatment
measure: Number of Participants Experiencing Categorical Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio
timeFrame: Days 0 - 5
Secondary outcomes:
measure: Number of Subjects Who Needed Mechanical Ventilation
timeFrame: Hospital discharge, approximately day 28
measure: Number of Subjects Who Developed Acute Respiratory Distress Syndrome (ARDS)
timeFrame: Hospital discharge, approximately day 28
measure: Hospital Length of Stay
timeFrame: Baseline to Day 28
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: Baseline to Day 28
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Stanford
country: United States
facility: Stanford University
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Boston
country: United States
facility: Beth Israel Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Emir Festic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Festic E, Carr GE, Cartin-Ceba R, Hinds RF, Banner-Goodspeed V, Bansal V, Asuni AT, Talmor D, Rajagopalan G, Frank RD, Gajic O, Matthay MA, Levitt JE. Randomized Clinical Trial of a Combination of an Inhaled Corticosteroid and Beta Agonist in Patients at Risk of Developing the Acute Respiratory Distress Syndrome. Crit Care Med. 2017 May;45(5):798-805. doi: 10.1097/CCM.0000000000002284.