LIPS-B: Lung Injury Prevention Study With Budesonide and Beta Agonist (Formoterol)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 61
- 试验地点
- 5
- 主要终点
- Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Budesonide (Drug)
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.
干预措施: Formoterol (Drug)
Placebo
Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio
时间窗: 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
时间窗: 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.
次要结局
- Number of Subjects Who Needed Mechanical Ventilation(Hospital discharge, approximately day 28)
- Number of Subjects Who Developed Acute Respiratory Distress Syndrome (ARDS)(Hospital discharge, approximately day 28)
- Intensive Care Unit (ICU) Length of Stay(Baseline to Day 28)
- Hospital Length of Stay(Baseline to Day 28)