LIPS-B: Lung Injury Prevention Study With Budesonide and Beta (LIPS-B)
|ClinicalTrials.gov Identifier: NCT01783821|
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : September 5, 2016
Last Update Posted : September 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome (ARDS)||Drug: Budesonide Drug: Placebo Drug: Formoterol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||LIPS-B: Lung Injury Prevention Study With Budesonide and Beta Agonist (Formoterol)|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Budesonide and Formoterol
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.
Subjects will receive the standard aerosolized dose of budesonide (0.5 mg).
Other Name: PulmicortDrug: Formoterol
Subjects will receive the standard aerosolized dose of formoterol (20 mcg) .
Other Name: Foradil Aerolizer
Placebo Comparator: Placebo
Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
Aerosolized normal saline will be prepared to mimic the intervention arm, with the quantity, appearance and timing of the doses the being the same.
- Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio [ Time Frame: baseline to day 5 after the first treatment ]Oxygen saturation (SpO2) was measured by pulse oximetry. FiO2 is the assumed proportion of oxygen concentration participating in gas exchange in the alveoli. All S/F measurements were performed per standard operating protocol using a Venturi mask titrated to obtain an oxygen saturation of 94 ± 2% unless the patient met this goal on room air or clinical status dictated an alternative delivery mode. This outcome measure was analyzed as a longitudinal continuous variable by a mixed effect model. The formula for the calculation of SpO2/FiO2 (or S/F ratio) is %saturation/proportion of FiO2 concentration.
- Number of Participants Experiencing Categorical Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio [ Time Frame: Days 0 - 5 ]The data in the table below represent the greatest change from baseline observed for any one participant over all individual post-baseline measurements.
- Number of Subjects Who Needed Mechanical Ventilation [ Time Frame: Hospital discharge, approximately day 28 ]
- Number of Subjects Who Developed Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: Hospital discharge, approximately day 28 ]ARDS was defined per Berlin definition. Chest radiographs of all ventilated (non-invasive or invasive) patients were reviewed as consistent or not consistent with ARDS by the site investigator. A second adjudication was performed by an alternate principal investigator blinded to subject identification and clinical data. Final diagnosis of ARDS was determined centrally after chest radiograph adjudication was considered together with other relevant clinical data.
- Hospital Length of Stay [ Time Frame: Baseline to Day 28 ]
- Intensive Care Unit (ICU) Length of Stay [ Time Frame: Baseline to Day 28 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783821
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States, 85721|
|United States, California|
|Stanford, California, United States, 94305|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Massachusetts|
|Beth Israel Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Emir Festic, MD||Mayo Clinic|