Bronchial Rheoplasty for Chronic Bronchitis

(RheSolve Trial)

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

270 Participants Needed

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?

Bronchial rheoplasty for chronic bronchitis appears generally safe, with no device-related serious adverse events reported in a study of 30 patients over 12 months. Some patients experienced mild bleeding (hemoptysis), but no severe complications were noted. ^{1 2 3 4 5}

How is bronchial rheoplasty different from other treatments for chronic bronchitis?

Bronchial rheoplasty is unique because it uses nonthermal pulsed electrical fields to treat the airways, aiming to reduce excessive mucus production by regenerating normal airway lining, unlike other treatments that may rely on medication or heat. ^{1 6 7 8 9}

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

Bronchial Rheoplasty for Treatment of Chronic Bronchitis. Twelve-Month Results from a Multicenter Clinical Trial. [2021]

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

Bronchial Thermoplasty in Patients with Severe Persistent Asthma: A Literature Review. [2023]

3. China pubmed.ncbi.nlm.nih.gov

[Analysis of short-term respiratory adverse events in 183 bronchial thermoplasty procedures]. [2018]

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

Can the Number of Radiofrequency Activations Predict Serious Adverse Events after Bronchial Thermoplasty? A Retrospective Case-Control Study. [2020]

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

How Effective and Safe Is Bronchial Thermoplasty in "Real Life" Asthmatics Compared to Those Enrolled in Randomized Clinical Trials? [2019]

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

Bronchial Thermoplasty: A Nonpharmacologic Therapy for Severe Asthma. [2019]

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

A prospective feasibility study of bronchial thermoplasty in the human airway. [2022]

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

Asthma control during the year after bronchial thermoplasty. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Bronchial thermoplasty for moderate or severe persistent asthma in adults. [2022]