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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

RARICO Trial 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.Check my eligibility

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.See study design

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.

RARICO Trial 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.

Select...

I am 40 years old or older.

RARICO Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction in total inspiratory resistance Rstat at the time of drug trough

Secondary outcome measures

ICU Length of stay

PaCO2

Reduction in Resistive pressure (Pres) at the time of drug trough

+4 more

Other outcome measures

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

RARICO 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

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,264,687 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the exact number of participants enrolled in this medical trial?

"Affirmative. According to information listed on clinicaltrials.gov, the trial which first appeared online in November of 2020 is now actively recruiting participants. 21 people from two sites need to be recruited for this medical experiment."

Answered by AI

What respiratory conditions can be addressed with Revefenacin Inhalation Solution [Yupelri]?

"Yupelri Inhalation Solution is most often employed to treat emphysema but can also provide symptom relief for issues such as chronic obstructive airway disease, nasal congestion due to a cold and chronic bronchitis."

Answered by AI

What potential side effects could be associated with Revefenacin Inhalation Solution [Yupelri]?

"Although there is evidence of safety, the lack of efficacy data results in Revefenacin Inhalation Solution [Yupelri] being rated a score 2 on our scale."

Answered by AI

Is this clinical experiment currently recruiting participants?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, first posted on 1st November 2020, is actively enrolling patients. 21 individuals must be sourced from 2 regional sites for the study to progress."

Answered by AI

How has Revefenacin Inhalation Solution [Yupelri] been tested in prior research experiments?

"Presently, there are 5 clinical trials underway for Revefenacin Inhalation Solution [Yupelri], with one of them in the final stage (Phase 3). These experiments primarily originate from Columbus, Ohio yet involve 40 diverse sites across America."

Answered by AI