Revefenacin in Acute Respiratory Insufficiency in COPD (RARICO)

University of California, Los Angeles (UCLA)

Status and phase

Completed

Phase 2

Conditions

COPD

Acute Respiratory Failure

Treatments

Drug: Revefenacin Inhalation Solution [Yupelri]

Drug: Ipratropium Bromide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04315558

IRB#20-000129

Details and patient eligibility

About

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.

Full 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:

Enrollment

21 patients

Sex

All

Ages

40+ years old

Volunteers

No 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
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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

21 participants in 2 patient groups

Revefenacin

Experimental group

Description:

Revefenacin will be delivered once daily via nebulizer. In order to allow for full blinding and steady Q6 hours regimen in control arm, at hours 6, 12 and 18 after the Revefenacin dose, nebulized normal saline will be delivered.

Treatment:

Drug: Revefenacin Inhalation Solution [Yupelri]

Ipratropium

Active Comparator group

Description:

Nebulized ipratropium will be delivered via nebulizer Q6 hours.

Treatment:

Drug: Ipratropium Bromide