Revefenacin in Acute Respiratory Insufficiency in COPD (RARICO)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Reduction in total inspiratory resistance Rstat at the time of drug trough
研究概览
简要总结
RARICO is a pragmatic, randomized, controlled, double-blinded, multi-center trial evaluating the safety and feasibility of nebulized revefenacin in comparison to nebulized ipratropium in patients with COPD and acute respiratory failure requiring invasive mechanical ventilation.
详细描述
Objective
To assess the efficacy of nebulized revefenacin in improving the lung mechanics of COPD patients with acute respiratory failure requiring invasive mechanical ventilation (MV), in comparison to a control group receiving the short-acting muscarinic antagonist ipratropium.
Hypothesis
Revefenacin is as efficacious as ipratropium in improving the lung mechanics of COPD patients with acute respiratory failure.
Study Design:
RARICO is a pragmatic, randomized, controlled, double-blinded, multi-center trial evaluating the safety and feasibility of nebulized revefenacin in comparison to nebulized ipratropium in patients with COPD and acute respiratory failure requiring invasive mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
blinded medication delivery
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 40 years of age
- •Acute respiratory failure requiring invasive mechanical ventilation
- •Documented history of COPD based on spirometric evidence of FEV1/FVC<70%
- •Smoking history >10 years (current or prior)
- •Invasive mechanical ventilation for < 96 hours
排除标准
- •Chronic invasive mechanical ventilation via tracheostomy. Patients with tracheostomy alone without chronic mechanical ventilation may be enrolled.
- •Expected duration of mechanical ventilation <24 hours
- •Hypersensitivity to muscarinic antagonists
- •Inability to tolerate albuterol
- •Lack of documented COPD history
- •For patients taking short- or long-acting muscarinic antagonists (SAMAs or LAMAs) at the time of screening, inability or unwillingness to undergo the SAMA or LAMA washout period (6 hours or 24 hours, respectively) prior to initiating study drug.
- •Presence of ARDS or acute congestive heart failure
- •Unwillingness or inability to remain on the study drug with for the duration of the study
- •Unwillingness or inability to have open-label muscarinic antagonists withheld for duration of the study
- •Unwillingness or inability to utilize the Puritan-Bennett 980 (PB980) ventilator
- •Pulmonary comorbidities such as pneumothorax or pneumomediastinum that, in the opinion of the investigator or clinical team, can pose a risk to subject safety or interfere with the subject's ability to complete the study procedures.
- •Documented restrictive lung disease or history of interstitial lung disease
- •Actual body weight exceeding 1 kg per centimeter of height
- •Pregnancy
- •AST or ALT > 3 times the upper limit of normal, or other clinically significant acute or chronic liver disease
- •Known history of glaucoma
- •Enrollment in other interventional clinical trial
- •Moribund patient not expected to survive >24 hours
- •Decision to withhold life-sustaining treatment, except in those patients committed to full support except cardiopulmonary resuscitation
- •Inability to obtain informed consent from patient or legally authorized representative (LAR)
研究组 & 干预措施
Revefenacin
Revefenacin will be delivered once daily via nebulizer. In order to allow for full blinding and steady Q6 hours regimen in control arm, at hours 6, 12 and 18 after the Revefenacin dose, nebulized normal saline will be delivered.
干预措施: Revefenacin Inhalation Solution [Yupelri] (Drug)
Ipratropium
Nebulized ipratropium will be delivered via nebulizer Q6 hours.
干预措施: Ipratropium Bromide (Drug)
结局指标
主要结局
Reduction in total inspiratory resistance Rstat at the time of drug trough
时间窗: 7 days
Reduction in total inspiratory resistance across the airways and ventilator circuit measured by the change in Static Resistance (Rstat) at the time of drug trough
次要结局
- Reduction in Resistive pressure (Pres) at the time of drug trough(7 days)
- PaCO2(7 days)
- ICU Length of stay(Hospital stay, expected to be less than 28 days)
- Reduction in total inspiratory resistance Rdyn at the time of drug trough(7 days)
- Respiratory therapist time at bedside(7 days)
- Reduction in total inspiratory resistance Rstat at the time of drug peak(7 days)
- Ventilator-free days to day 28(Hospital stay, expected to be less than 28 days)
研究者
Igor Barjaktarevic, MD, PhD
Principal Investigator
University of California, Los Angeles