Revefenacin for COPD-Related Respiratory Insufficiency
(RARICO Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of California, Los Angeles
Must not be taking: Muscarinic antagonists
Disqualifiers: ARDS, Congestive heart failure, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
If you are taking short- or long-acting muscarinic antagonists, you will need to stop them for a washout period (time without taking certain medications) of 6 hours for short-acting and 24 hours for long-acting before starting the study drug. Other medications are not specified, so it's best to discuss with the trial team.
What data supports the effectiveness of the drug Revefenacin for COPD-related respiratory insufficiency?
Revefenacin has been shown to significantly improve lung function and health status in patients with moderate to very severe COPD, as demonstrated in phase 3 trials. Additionally, ipratropium bromide, a component of the treatment, has been effective in improving airflow in COPD patients, although it was found to be less effective than formoterol in one study.12345
How is the drug Revefenacin different from other COPD treatments?
Research Team
Igor Barjaktarevic, MD
Principal Investigator
University of California, Los Angeles
DT
Donald Tashkin, MD
Principal Investigator
University of California, Los Angeles
Eligibility Criteria
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.Inclusion Criteria
I have been on a breathing machine for less than 96 hours.
You have a history of COPD shown by a specific breathing test.
I am on a breathing machine due to severe breathing problems.
See 2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive nebulized revefenacin or ipratropium while on invasive mechanical ventilation
7 days
Daily monitoring in ICU
Follow-up
Participants are monitored for safety and effectiveness after treatment
Hospital stay, expected to be less than 28 days
Treatment Details
Interventions
- Ipratropium Bromide (Bronchodilator)
- Revefenacin Inhalation Solution [Yupelri] (Bronchodilator)
Trial OverviewThe 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.
Participant Groups
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.
Ipratropium Bromide is already approved in European Union, United States, Canada, Japan for the following indications:
πͺπΊ Approved in European Union as Atrovent for:
- Chronic obstructive pulmonary disease (COPD)
- Bronchospasm
πΊπΈ Approved in United States as Atrovent for:
- Chronic obstructive pulmonary disease (COPD)
- Bronchospasm
π¨π¦ Approved in Canada as Combivent for:
- Chronic obstructive pulmonary disease (COPD)
- Bronchospasm
π―π΅ Approved in Japan as Ipravent for:
- Chronic obstructive pulmonary disease (COPD)
- Bronchospasm
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ronald Reagan Medical Center at UCLALos Angeles, CA
Santa Monica UCLASanta Monica, CA
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Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
Trials
1594
Patients Recruited
10,430,000+
Theravance Biopharma
Industry Sponsor
Trials
74
Patients Recruited
8,600+
Mylan Pharmaceuticals Inc
Industry Sponsor
Trials
166
Patients Recruited
13,000+
References
Revefenacin: First Global Approval. [2023]Revefenacin (YUPELRIβ’) inhalation solution, a long-acting muscarinic antagonist (i.e. an anticholinergic) developed by Theravance Biopharma and Mylan, is the first and currently the only once-daily, nebulized bronchodilator to be approved in the USA for the treatment of chronic obstructive pulmonary disease (COPD). In November 2018, based on results of three phase III trials, the US Food and Drug Administration granted market authorization to revefenacin for the maintenance treatment of patients with COPD. This article summarizes the milestones in the development of revefenacin leading to this first global approval.
Inhaled formoterol dry powder versus ipratropium bromide in chronic obstructive pulmonary disease. [2022]We compared the effectiveness of inhaled formoterol with that of ipratropium in the treatment of chronic obstructive pulmonary disease (COPD). After a 2-wk run-in period, 780 patients with COPD were randomized to receive for 12 wk formoterol dry powder 12 or 24 microg twice daily, ipratropium bromide 40 microg four times daily, or placebo in a multicenter, double-blind, parallel-group study. The primary efficacy variable was the area under the curve for forced expiratory volume in 1 s (FEV(1)) measured over 12 h after 12 wk of treatment. Secondary variables included diary symptoms and quality of life. Both doses of formoterol and ipratropium significantly increased the area under the curve for FEV(1) in comparison with placebo (all p or = 0.3). All study treatments exhibited a similar safety profile. We conclude that formoterol is more effective than ipratropium bromide in the treatment of COPD, as the efficacy of ipratropium on airflow obstruction does not translate into a clinical benefit that patients can perceive.
Bronchodilator effect of Ipraterol on methacholine-induced bronchoconstriction in asthmatic patients. [2013]The addition of ipratropium, a synthetic cholinergic antagonist, to beta2-agonist therapy provides an additive improvement in adult with acute severe asthma and COPD because of increased vagal tone in the airways. We asked whether ipratropium in combination with fenoterol (Ipraterol) improved pulmonary function in comparison with original Berodual.
Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease. [2023]Replicate, 12-week, phase 3 trials (0126 and 0127) of once-daily nebulized revefenacin 175 ΞΌg vs placebo demonstrated significant bronchodilation and improvements in health status in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). This post hoc analysis evaluated improvement in patient-reported outcomes (PROs), including the St. George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Clinical COPD Questionnaire (CCQ) in both women and men.
Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI. [2015]We compared the efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler, a novel propellant-free inhaler, versus chlorofluorocarbon (CFC)-metered dose inhaler (MDI) and ipratropium Respimat inhaler in patients with COPD. This was a multinational, randomized, double-blind, double-dummy, 12-week, parallel-group, active-controlled study. Patients with moderate to severe COPD were randomized to ipratropium bromide/albuterol (20/100mcg) Respimat inhaler, ipratropium bromide/albuterol MDI [36mcg/206mcg (Combivent Inhalation Aerosol MDI)], or ipratropium bromide (20mcg) Respimat inhaler. Each medication was administered four times daily. Serial spirometry was performed over 6h (0.15min, then hourly) on 4 test days. The primary efficacy variable was forced expiratory volume in 1s (FEV(1)) change from test day baseline at 12 weeks. A total of 1209 of 1480 randomized, treated patients completed the study; the majority were male (65%) with a mean age of 64 yrs and a mean screening pre-bronchodilator FEV(1) (percent predicted) of 41%. Ipratropium bromide/albuterol Respimat inhaler had comparable efficacy to ipratropium bromide/albuterol MDI for FEV(1) area under the curve at 0-6h (AUC(0-6)), superior efficacy to ipratropium Respimat inhaler for FEV(1) AUC(0-4) and comparable efficacy to ipratropium Respimat inhaler for FEV(1) AUC(4-6). All active treatments were well tolerated. This study demonstrates that ipratropium bromide/albuterol 20/100mcg inhaler administered four times daily for 12 weeks had equivalent bronchodilator efficacy and comparable safety to ipratropium bromide/albuterol 36mcg/206mcg MDI, and significantly improved lung function compared with the mono-component ipratropium bromide 20 mcg Respimat inhaler. [Clinical Trial Identifier Number: NCT00400153].
COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study. [2021]Ipratropium bromide/albuterol Respimat inhaler (CVT-R) was developed as an environmentally friendly alternative to ipratropium bromide/albuterol metered-dose inhaler (CVT-MDI), which uses a chlorofluorocarbon propellant.
One-Year Evaluation of the Safety and Efficacy of Ipratropium Bromide HFA and CFC Inhalation Aerosols in Patients with Chronic Obstructive Pulmonary Disease. [2023]Ipratropium bromide (IB) is an established and effective first-line maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). A new IB metered-dose inhaler (MDI) using hydrofluoroalkane 134a propellant (IB HFA) has been developed as an alternative to the MDI containing chlorofluorocarbon (IB CFC).
Inhaled albuterol/salbutamol and ipratropium bromide and their combination in the treatment of chronic obstructive pulmonary disease. [2015]Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality throughout the world. Combination therapy with albuterol and ipratropium bromide was approved > 15 years ago for the treatment of COPD. We review the mechanism of action, clinical efficacy, and safety of albuterol, ipratropium and combined albuterol-ipratropium therapy.
Ipratropium bromide and noninvasive ventilation treatment for COPD. [2022]To explore the effects of ipratropium bromide combined with non-invasive ventilation for patients with both chronic obstructive pulmonary disease (COPD) and respiratory failure.