NCT01783821

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

LIPS-B: Lung Injury Prevention Study With Budesonide and Beta Agonist (Formoterol)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Distress Syndrome (ARDS)

Interventions

Type	Name	Description
DRUG	Budesonide	Subjects will receive the standard aerosolized dose of budesonide (0.5 mg).
DRUG	Placebo	Aerosolized normal saline will be prepared to mimic the intervention arm, with the quantity, appearance and timing of the doses the being the same.
DRUG	Formoterol	Subjects will receive the standard aerosolized dose of formoterol (20 mcg) .

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-07-01
• Completion: 2015-12-01
• First posted: 2013-02-05
• Last updated: 2016-09-05
• Results posted: 2016-09-05

Locations

5 sites across 1 country: United States