Revefenacin in Acute Respiratory Insufficiency in COPD
- Conditions
- COPDAcute Respiratory Failure
- Interventions
- Registration Number
- NCT04315558
- Lead Sponsor
- University of California, Los Angeles
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 21
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Revefenacin Revefenacin Inhalation Solution [Yupelri] 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. Ipratropium Ipratropium Bromide Nebulized ipratropium will be delivered via nebulizer Q6 hours.
- Primary Outcome Measures
Name Time Method Reduction in total inspiratory resistance Rstat at the time of drug trough 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
- Secondary Outcome Measures
Name Time Method Reduction in total inspiratory resistance Rdyn at the time of drug trough 7 days Reduction in total inspiratory resistance across the airways and ventilator circuit measured by the change in Dynamic Resistance (Rdyn) at the time of drug trough
Respiratory therapist time at bedside 7 days RT resource utilization as reflected in the total effective time spent at the bedside providing care
Reduction in Resistive pressure (Pres) at the time of drug trough 7 days Reduction in total inspiratory resistance across the airways and ventilator circuit measured by the change in Resistive pressure (Pres) at the time of drug trough
PaCO2 7 days Arterial partial pressure of CO2 measured at the drug trough
ICU Length of stay Hospital stay, expected to be less than 28 days Time spent in the ICU from the enrollment in the study through the same-stay discharge from the hospital
Reduction in total inspiratory resistance Rstat at the time of drug peak 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 peak
Ventilator-free days to day 28 Hospital stay, expected to be less than 28 days Time spent ventilator-free from the day of enrollment in the study through the same-stay discharge from the hospital
Trial Locations
- Locations (2)
Ronald Reagan Medical Center at UCLA
🇺🇸Los Angeles, California, United States
Santa Monica UCLA
🇺🇸Santa Monica, California, United States