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Revefenacin in Acute Respiratory Insufficiency in COPD | Clinical Trials | Clareo Health

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Revefenacin in Acute Respiratory Insufficiency in COPD

Revefenacin in Acute Respiratory Insufficiency in COPD (RARICO)

NCT04315558•University of California, Los Angeles

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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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
+10 more criteria

Locations (2)

Ronald Reagan Medical Center at UCLA

Los Angeles, California, United States

Santa Monica UCLA

Santa Monica, California, United States

Key Dates

Start Date

November 1, 2020

Primary Completion Date

January 1, 2025

Completion Date

January 1, 2025

Last Updated

August 13, 2025

Enrollment

ACTUAL participants

Conditions

COPDAcute Respiratory Failure

Interventions

Revefenacin Inhalation Solution [Yupelri]

DRUG

Ipratropium Bromide

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Revefenacin in Acute Respiratory Insufficiency in COPD

Inclusion Criteria

Exclusion Criteria

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