Bronchial Rheoplasty for Chronic Bronchitis
(RheSolve Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a prospective, randomized, parallel group, double-blind, sham-controlled, multicenter clinical trial following patients to 2 years. The objective is to assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis. A total of 270 patients will be randomized at up to 40 study centers in the United States, Canada, and Europe.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications. However, you must be on certain long-acting bronchodilators (with or without inhaled corticosteroids) for at least 8 weeks before joining, unless you've tried them in the past year without success or had a bad reaction.
Is bronchial rheoplasty safe for treating chronic bronchitis?
How is bronchial rheoplasty different from other treatments for chronic bronchitis?
Who Is on the Research Team?
Frank Sciurba, MD
Principal Investigator
UPMC; Division of Pulmonary and Critical Care Medicine
Arschang Valipour, MD
Principal Investigator
Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology; Vienna, Austria
Are You a Good Fit for This Trial?
Adults over 35 with moderate to severe chronic bronchitis, a history of smoking, and specific scores on respiratory health questionnaires. They must be on stable medication for at least 8 weeks and able to walk more than 225 meters. Excluded are those with emphysema, asthma, certain heart conditions or devices that can't be turned off during procedures, unresolved lung cancer, recent smokers or other serious medical issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the RheOx Bronchial Rheoplasty or sham procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RheOx Bronchial Rheoplasty
- Sham Procedure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gala Therapeutics, Inc.
Lead Sponsor