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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ hospital stay, expected to be less than 28 days

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.

0 / 2Eligibility criteria met