Revefenacin in Acute Respiratory Insufficiency in COPD

Description

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.

Conditions

COPD, Acute Respiratory Failure

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Study Overview

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Study Details

Study overview

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.

Revefenacin in Acute Respiratory Insufficiency in COPD (RARICO)

Revefenacin in Acute Respiratory Insufficiency in COPD

Condition
COPD
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Ronald Reagan Medical Center at UCLA, Los Angeles, California, United States, 90095

Santa Monica

Santa Monica UCLA, Santa Monica, California, United States, 90404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Los Angeles,

Igor Z Barjaktarevic, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Donald Tashkin, MD, STUDY_DIRECTOR, University of California, Los Angeles

Study Record Dates

2024-06-30