Conditions: Acute Respiratory Distress Syndrome (ARDS)
Keywords: Acute respiratory distress syndrome (ARDS)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 61
Healthy volunteers: no

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.

Arms:
arm 1: Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours. arm 2: Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.

Interventions: intervention 1: Budesonide intervention 2: Placebo intervention 3: Formoterol
Intervention descriptions: intervention 1: Subjects will receive the standard aerosolized dose of budesonide (0.5 mg). intervention 2: Aerosolized normal saline will be prepared to mimic the intervention arm, with the quantity, appearance and timing of the doses the being the same. intervention 3: Subjects will receive the standard aerosolized dose of formoterol (20 mcg) .

Protocol document: