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Bronchodilator

Revefenacin for COPD-Related Respiratory Insufficiency (RARICO Trial)

Phase 2
Recruiting
Led By Igor Z Barjaktarevic, MD, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acute respiratory failure requiring invasive mechanical ventilation
Adults ≥ 40 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hospital stay, expected to be less than 28 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing whether revefenacin is safe and effective in comparison to ipratropium for patients with COPD who require mechanical ventilation.

Who is the study for?
Adults over 40 with a history of smoking for more than 10 years and diagnosed COPD, currently needing mechanical ventilation due to acute respiratory failure. They must have been on the ventilator for less than 96 hours and have confirmed COPD by specific lung function tests.
What is being tested?
The trial is testing revefenacin inhalation solution against ipratropium bromide in patients with COPD who are receiving invasive mechanical ventilation. The goal is to see which treatment is safer and works better under these conditions.
What are the potential side effects?
Possible side effects may include dry mouth, constipation, trouble urinating, blurred vision, dizziness, headaches or worsening of breathing problems. These can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on a breathing machine due to severe breathing problems.
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I am 40 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hospital stay, expected to be less than 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and hospital stay, expected to be less than 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction in total inspiratory resistance Rstat at the time of drug trough
Secondary study objectives
ICU Length of stay
PaCO2
Reduction in Resistive pressure (Pres) at the time of drug trough
+4 more
Other study objectives
Exploratory: Ventilator compliance analysis (ventilator dyssynchrony, pressure-volume curve analysis, expiratory flow curve analysis)
Safety: Paradoxical bronchospasm, Hypersensitivity reaction, Severe urinary retention not explained by other reasons, Severe constipation not explained by other reasons

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RevefenacinExperimental Treatment1 Intervention
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.
Group II: IpratropiumActive Control1 Intervention
Nebulized ipratropium will be delivered via nebulizer Q6 hours.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,557 Previous Clinical Trials
10,263,846 Total Patients Enrolled
Theravance BiopharmaIndustry Sponsor
73 Previous Clinical Trials
8,598 Total Patients Enrolled
Mylan Pharmaceuticals IncIndustry Sponsor
163 Previous Clinical Trials
11,283 Total Patients Enrolled
~4 spots leftby Oct 2025
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