RheOx Device for Chronic Bronchitis

(Gala_EFS Trial)

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

21 Participants Needed

Trial Summary

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 data supports the effectiveness of the RheOx treatment for chronic bronchitis?

Research on similar treatments, like the Lung Flute and oscillating positive expiratory pressure (OPEP) devices, shows they can help clear mucus and improve symptoms in conditions like chronic bronchitis and COPD. These devices have been associated with fewer disease flare-ups and better quality of life, suggesting that RheOx might offer similar benefits. ^{1 2 3 4 5}

How is the RheOx treatment for chronic bronchitis different from other treatments?

The RheOx treatment for chronic bronchitis is unique because it involves a device that regulates breathing by providing resistance to exhalation, which helps prevent over-breathing and improves symptoms without the need for drugs or hormones, unlike traditional treatments that often rely on medication. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial is testing a device called RheOx, which uses energy to treat the inner layers of the airways in patients with chronic bronchitis. The treatment involves two sessions, one for each lung, performed a few weeks apart. The goal is to see if this approach can safely help improve breathing in these patients.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Protocol of a Randomized Controlled Study of the PneumRx Endobronchial Coil System versus Standard-of-Care Medical Management in the Treatment of Subjects with Severe Emphysema (ELEVATE). [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of the use of an oscillating positive expiratory pressure device in bronchiectasis with frequent exacerbations: a single-arm pilot study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Lung flute improves symptoms and health status in COPD with chronic bronchitis: A 26 week randomized controlled trial. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Impact of Oscillating Positive Expiratory Pressure Device Use on Post-Discharge Hospitalizations: A Retrospective Cohort Study Comparing Patients with COPD or Chronic Bronchitis Using the Aerobika® and Acapella® Devices. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Randomized controlled crossover trial of a new oscillatory device as add-on therapy for COPD. [2012]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Outpatient clinic treatment of broncho-obstructive syndrome using an artificial regulator of respiration]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Bronchodilating efficacy of an open-spacer device compared to three other spacers. [2006]

8. Georgia (Republic) pubmed.ncbi.nlm.nih.gov

[Effectiveness of treatment of bronchoobstruction in children with acute respiratory infections using home-made spacer]. [2013]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A device for inserting a catheter into the trachea and bronchi for conducting endobronchial therapy]. [2006]

10. England pubmed.ncbi.nlm.nih.gov

Aerosol bronchodilator administration in ventilator circuits. [2019]