COMPLETED

Revefenacin in Acute Respiratory Insufficiency in COPD

Conditions

COPD Acute Respiratory Failure Long acting muscarinic antagonist nebulizer mechanical ventilation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Revefenacin in Acute Respiratory Insufficiency in COPD (RARICO)

Quick Facts

Study Start:2020-11-01

Study Completion:2025-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04315558

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.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)

Inclusion Criteria

Exclusion 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)

Contacts and Locations

Principal Investigator

Igor Z Barjaktarevic, MD, PhD

PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Donald Tashkin, MD

STUDY_DIRECTOR

University of California, Los Angeles

Study Locations (Sites)

Ronald Reagan Medical Center at UCLA

Los Angeles, California, 90095

United States

Santa Monica UCLA

Santa Monica, California, 90404

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-01

Study Completion Date2025-01-01

Study Record Updates

Study Start Date2020-11-01

Study Completion Date2025-01-01

Terms related to this study

Keywords Provided by Researchers

COPD
Acute Respiratory failure
Long acting muscarinic antagonist
nebulizer
mechanical ventilation

Additional Relevant MeSH Terms

COPD
Acute Respiratory Failure