RheOx Device for Chronic Bronchitis

(Gala_EFS Trial)

Not currently recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gala Therapeutics, Inc.

Must not be taking: Prednisolone, Prednisone, Anticoagulants

Disqualifiers: Lung cancer, Cardiomyopathy, Smoking, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called RheOx, a medical device, to determine its safety and effectiveness for individuals with chronic bronchitis. This long-term condition causes a persistent cough with mucus. Researchers aim to assess whether this treatment can help manage symptoms and improve quality of life. The trial targets individuals who have had chronic bronchitis for at least two years and have experienced worsening symptoms requiring extra care in the past year. Participants must have a history of smoking and be able to undergo certain medical procedures. As an unphased trial, this study offers a unique opportunity for patients to contribute to the early understanding of a potentially beneficial treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but if you are on anticoagulants (blood thinners), you must be able to stop them for at least seven days before the procedure. Also, you cannot participate if you are taking more than 10 mg of prednisolone or prednisone per day.

What prior data suggests that the RheOx device is safe for chronic bronchitis?

Research has shown that the RheOx device, used in a treatment called Bronchial Rheoplasty, has been tested for safety in people with chronic bronchitis. One study found the treatment to be safe, with no serious side effects linked to it. Another study followed patients for two years and found that the treatment can be done safely and might help improve symptoms. Overall, the treatment was well-tolerated, meaning most people did not experience significant negative effects. These findings suggest that RheOx is generally safe for people with chronic bronchitis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about RheOx because it offers a novel approach to treating chronic bronchitis by using a procedure called Bronchial Rheoplasty. Unlike traditional treatments like bronchodilators and steroids that primarily focus on relieving symptoms, RheOx targets the root cause by using energy to reduce the overproduction of mucus in the airways. This approach has the potential to provide more lasting relief and improve quality of life for patients with chronic bronchitis.

What evidence suggests that the RheOx device is effective for chronic bronchitis?

Research has shown that the RheOx device, used in a procedure called bronchial rheoplasty, yields promising results for people with chronic bronchitis. In studies, patients experienced 34% fewer moderate and 64% fewer severe COPD flare-ups in the year following treatment. These findings suggest significant symptom improvement and confirm the procedure's safety. Patients reported feeling better after treatment, indicating its potential effectiveness. Overall, RheOx treatment, which participants in this trial will receive, may help reduce the frequency and severity of chronic bronchitis episodes. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with chronic bronchitis for at least two years, an FEV1 between 30-80% of predicted, and a history of COPD exacerbations. They must have smoked the equivalent of ten pack-years and be able to undergo bronchoscopies. Exclusions include recent arrhythmias or lung cancer, severe other medical conditions, participation in another study within six weeks, inability to walk over 100 meters in six minutes, recent smoking or respiratory infections.

Inclusion Criteria

I have had chronic bronchitis for at least two years.

I have had at least one severe COPD flare-up in the last year.

My lung function test shows 30-80% of the expected result.

Exclusion Criteria

You have used any form of smoking, including tobacco, marijuana, e-cigarettes, or vaping, in the past 6 months.

Subject has an implantable cardioverter defibrillator or pacemaker.

Subject is pregnant, nursing, or planning to get pregnant during study duration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Two sessions of RheOx treatment delivered one month apart, targeting the right lung first and then the left lung

2 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tests such as CT scans, respiratory function tests, and exercise testing

12 months

What Are the Treatments Tested in This Trial?

Interventions

• RheOx

Trial Overview The RheOx system is being tested for its safety and effectiveness in treating patients with chronic bronchitis. The study involves participants undergoing bronchoscopy procedures where RheOx will be used to potentially improve their respiratory symptoms.

How Is the Trial Designed?

Group I: RheOx Treatment Experimental Treatment 1 Intervention

RheOx Treatment (i.e., Bronchial Rheoplasty)

Who Is Running the Clinical Trial?

Gala Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

420+

Published Research Related to This Trial

The new oscillatory device (Pulsehaler) was found to be safe and significantly improved 6-minute walk (6MW) performance in patients with moderate-to-very severe COPD, with 91% of participants showing a clinically significant improvement after treatment.

Patients using the oscillatory device also experienced significant enhancements in pulmonary function and health-related quality of life (HRQOL), particularly in dyspnea and mastery, compared to a control device that provided continuous positive air pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled crossover trial of a new oscillatory device as add-on therapy for COPD. Fridlender, ZG., Arish, N., Laxer, U., et al.[2012]

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. 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.

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

Bronchial rheoplasty for chronic bronchitis: 2 Outcome data were collected at baseline and at 3, 6, 12 and 24 months after the second procedure. Responder rates were calculated by using ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38151258/

Bronchial rheoplasty for chronic bronchitis: 2-year results ... This study extends the findings from previous feasibility studies, demonstrating that BR can be performed safely and may significantly improve symptoms.

5. mayo.edu mayo.edu/research/clinical-trials/cls-20516079

A Study to Evaluate RheOx Bronchial Rheoplasty System ... The purpose of this study is to assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic ...

6. bmjopenrespres.bmj.com bmjopenrespres.bmj.com/content/10/1/e001710

Bronchial rheoplasty for chronic bronchitis: 2-year results ... In a multicentre observational study of BR in patients with COPD and CB, the procedure was shown to be safe with no procedure-related SAEs.

7. publications.ersnet.org publications.ersnet.org/content/erjor/early/2025/05/08/2312054100480-2025

Bronchial rheoplasty for chronic bronchitis: real world ... The primary outcomes were safety and symptom burden at 12 months, evaluated by (serious) adverse events (SAE) and questionnaire scores (CAT and ...

8. 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 ...