Open
Actively Recruiting
Revefenacin in Acute Respiratory Insufficiency in COPD
About
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
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Study Stats
Protocol No.
20-000129
Category
Lung/Respiratory Disorders
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood