Bronchial Rheoplasty for Chronic Bronchitis

(RheSolve Trial)

Not currently recruiting at 39 trial locations

Overseen By Adnan Majid, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gala Therapeutics, Inc.

Must be taking: Long acting bronchodilators

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Asthma, Lung cancer, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Bronchial Rheoplasty, using the RheOx device, to help people with chronic bronchitis, a component of COPD that causes ongoing coughing and mucus production. The main goal is to determine if this treatment is safe and effectively relieves symptoms. Participants will be randomly assigned to receive either the actual treatment or a sham (fake) procedure for comparison. This trial may suit those who have had a productive cough for at least two years and currently use long-acting inhalers to manage their condition. As an unphased study, this trial offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.

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.

What prior data suggests that Bronchial Rheoplasty is safe for treating chronic bronchitis?

Research has shown that Bronchial Rheoplasty for chronic bronchitis is generally safe. In earlier studies, this treatment led to a noticeable decrease in COPD flare-ups, with a 34% reduction in moderate flare-ups and a 64% reduction in severe ones compared to the previous year.

Another study confirmed that Bronchial Rheoplasty is safe and improves symptoms for people with COPD and chronic bronchitis. Patients reported feeling better after the procedure, and studies found it well-tolerated.

Overall, these studies have demonstrated that the treatment reduces symptoms and is considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about RheOx Bronchial Rheoplasty because it offers a unique approach to treating chronic bronchitis. Unlike standard treatments that often rely on medications to manage symptoms, RheOx targets the overproduction of mucus directly by delivering energy to the airway lining to reduce mucus-secreting cells. This innovative approach aims to address the root cause of symptoms rather than just alleviating them, potentially offering longer-lasting relief for patients.

What evidence suggests that Bronchial Rheoplasty is effective for chronic bronchitis?

Research has shown that Bronchial Rheoplasty, using the RheOx system, holds promise for treating chronic bronchitis. In a previous study, patients experienced 34% fewer moderate COPD flare-ups and 64% fewer severe ones compared to the year before treatment. This reduction in symptom flare-ups can greatly enhance daily life. Additionally, follow-ups at 6 and 12 months observed safety and symptom improvements. In this trial, participants will receive either the RheOx Treatment or a Sham Procedure. These early results suggest that the RheOx Treatment could effectively manage chronic bronchitis symptoms. ^{1 2 3 4 6}

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

In the opinion of the Primary investigator, patient is able to undergo 2 bronchoscopies under general anesthesia and is able to adhere to the study follow-up schedule

I am 35 years old or older.

You have a CAT score of 10 or higher.

Exclusion Criteria

I have a lung spot that might need treatment during the study.

I need more than 10 mg of oral steroids daily for my condition.

I have an ongoing lung infection that hasn't healed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RheOx Bronchial Rheoplasty or sham procedure

1 month

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• RheOx Bronchial Rheoplasty
• Sham Procedure

Trial Overview The trial is testing the RheOx Bronchial Rheoplasty System against a sham procedure to see if it's safe and effective in treating symptoms of chronic bronchitis in COPD patients. It's randomized and double-blind meaning neither the participants nor the researchers know who receives which treatment until after the results are collected.

How Is the Trial Designed?

Group I: RheOx Treatment Experimental Treatment 1 Intervention

Group II: Sham Procedure Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Gala Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

420+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10753755/

Bronchial rheoplasty for chronic bronchitis: 2-year results ... There was a 34% reduction in moderate and a 64% reduction in severe COPD exacerbation events compared with the year prior to treatment.

2. bmjopenrespres.bmj.com bmjopenrespres.bmj.com/content/bmjresp/10/1/e001710.full.pdf

Bronchial rheoplasty for chronic bronchitis: 2 Bronchial rheoplasty (BR) with the RheOx system delivers non ... Outcome data were collected at baseline and at 3, 6, 12 and 24 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04677465

Clinical Study of the RheOx Bronchial Rheoplasty System ... 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.

4. publications.ersnet.org publications.ersnet.org/content/erjor/early/2025/05/08/23120541.00480-2025.full.pdf

Bronchial rheoplasty for chronic bronchitis: real world ... Data collection. The primary outcomes were safety and efficacy at 12 months. Safety was assessed through the collection and monitoring of ...

5. atsjournals.org atsjournals.org/doi/10.1164/rccm.201908-1546OC

Bronchial Rheoplasty for Treatment of Chronic Bronchitis. ... Follow-up through 6 months (primary outcome) and 12 months included assessment of adverse events, airway histology, and changes in symptoms ...

6. journal.chestnet.org journal.chestnet.org/article/S0012-3692(21)03113-5/fulltext

BRONCHIAL RHEOPLASTY FOR CHRONIC BRONCHITIS CONCLUSIONS: Bronchial Rheoplasty was safe and well-tolerated in this study of chronic bronchitis patients. Clinically meaningful reductions in symptoms and ...