Nebulized revefenacin for COPD patients with acute respiratory failure

Revefenacin in Acute Respiratory Insufficiency in COPD (RARICO)

This study is testing if a new inhaled medication called revefenacin can help people with COPD who are having severe breathing problems feel better, compared to a standard treatment called ipratropium.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: University of California, Los Angeles (other)
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT04315558 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of nebulized revefenacin compared to nebulized ipratropium in patients with COPD who are experiencing acute respiratory failure and require invasive mechanical ventilation. It is a pragmatic, randomized, controlled, double-blinded, multi-center trial designed to assess improvements in lung mechanics. The study aims to determine if revefenacin is as effective as ipratropium in this patient population. Participants will receive either treatment while being monitored for safety and feasibility.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with a documented history of COPD and acute respiratory failure requiring invasive mechanical ventilation.

Not a fit: Patients with chronic invasive mechanical ventilation via tracheostomy or those expected to require mechanical ventilation for less than 24 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve lung function and outcomes for COPD patients experiencing acute respiratory failure.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison of revefenacin and ipratropium in this context is novel.

Eligibility 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 \< 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)

Where this trial is running

Los Angeles, California and 1 other locations

• Ronald Reagan Medical Center at UCLA — Los Angeles, California, United States (RECRUITING)
• Santa Monica UCLA — Santa Monica, California, United States (RECRUITING)

Study contacts

• Principal investigator: Igor Z Barjaktarevic, MD, PhD — University of California, Los Angeles
• Study coordinator: Leslie Cortes

Conditions: COPD, Acute Respiratory Failure, Acute Respiratory failure, Long acting muscarinic antagonist, nebulizer, mechanical ventilation