Revefenacin in Acute Respiratory Insufficiency in COPD

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborators: Mylan Pharmaceuticals; Theravance Biopharma
• Treatments: Bromides; Ipratropium

Criteria

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 < 48 hours

Exclusion Criteria:

• Invasive mechanical ventilation for > 48 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)