Clinical Study of the RheOx Bronchial Rheoplasty System in Treating the Symptoms of Chronic Bronchitis

NCT ID: NCT04677465

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-07
• Study Completion Date: 2025-10-31

Brief Summary

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.

Conditions

Chronic Bronchitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

RheOx Treatment

Group Type: EXPERIMENTAL

RheOx Bronchial Rheoplasty

Intervention Type: DEVICE

bronchial rheoplasty is a staged procedure wherein pulsed electric fields are delivered to the right lung in the first treatment visit, and then the left lung is treated approximately 1 month later.

Sham Procedure

Group Type: SHAM_COMPARATOR

Sham Procedure

Intervention Type: DEVICE

staged sham procedure wherein bronchoscopy is performed, the catheter is inserted into the right lung, but energy is not delivered; then the same steps are performed in the left lung approximately 1 month later (no energy is delivered to the patient)

Interventions

RheOx Bronchial Rheoplasty

bronchial rheoplasty is a staged procedure wherein pulsed electric fields are delivered to the right lung in the first treatment visit, and then the left lung is treated approximately 1 month later.

Intervention Type: DEVICE

Sham Procedure

staged sham procedure wherein bronchoscopy is performed, the catheter is inserted into the right lung, but energy is not delivered; then the same steps are performed in the left lung approximately 1 month later (no energy is delivered to the patient)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient is at least 35 years of age.

2. Patient has chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out.

3. Patient has a CAT score ≥ 10.

4. Patient has an SGRQ score ≥ 25.

5. Patient's responses to the first two questions of the CAT instrument sum to ≥ 7 points or the sum is 6 points and the patient's total CAT score is > 20 points.

6. Patient has FEV1/FVC < 0.70.

7. Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥ 30%.

8. Patient is receiving guideline directed pharmacotherapy which includes one or more long acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks prior to randomization, unless the patient has attempted such therapy within the past 1 year without significant clinical response or had an adverse reaction.

9. Patient has a cigarette smoking history of at least ten pack years.

10. 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

Exclusion Criteria

1. Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).

2. Patient has a steroid-dependent condition requiring >10 mg of oral corticosteroid per day.

3. Patient has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator) that cannot be turned off during the procedure.

4. Patient has a history of ventricular tachy-arrhythmia or clinically significant atrial tachyarrhythmia within the past two years, unless the arrhythmia has been treated and/or patient is in regular rhythm during the screening phase.

5. Patient has unresolved lung cancer.

6. Patient has a pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.

7. Patient had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior pneumothorax without lung resection, pleural procedures without surgery, or segmentectomy are acceptable.

8. Patient has emphysema of greater than or equal to 25% as quantified on baseline HRCT scan (low attenuation area less than -950HU) as determined by the CT Core Lab.

9. Patient has asthma based on Global Initiative for Asthma (GINA) criteria.

10. Patient has clinically significant bronchiectasis influencing the patient's clinical symptoms of cough and phlegm.

11. Patient has actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.

12. Patient is unable to walk over 225 meters in 6 minutes.

13. Patient has a serious medical condition that, in the Primary investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to therapy (e.g., congestive heart failure, cardiomyopathy, or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c >8%), uncontrolled hypertension (diastolic BP >100mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy).

14. Patient has uncontrolled GERD.

15. Patient has known severe pulmonary hypertension.

16. Patient has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines).

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

18. Patient is currently participating in another clinical study involving an investigational product

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gala Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Sciurba, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC; Division of Pulmonary and Critical Care Medicine

Arschang Valipour, MD

Role: PRINCIPAL_INVESTIGATOR

Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology; Vienna, Austria

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Norton Thoracic

Phoenix, Arizona, United States

Honor Health

Scottsdale, Arizona, United States

Syed M. Alam, MD Pulmonology (Bakersfield Heart)

Bakersfield, California, United States

UC Davis Medical Center

Davis, California, United States

Scripps Health

Encinitas, California, United States

University of Southern California

Los Angeles, California, United States

UCLA Harbor Lundquist Institute

Torrance, California, United States

University of Colorado

Aurora, Colorado, United States

Mayo Clinic

Jacksonville, Florida, United States

The Cardiac and Vascular Institute Research Foundation

Tallahassee, Florida, United States

Emory University

Atlanta, Georgia, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

University of Kansas School of Medicine

Kansas City, Kansas, United States

Tulane University Medical Center

New Orleans, Louisiana, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Minnesota Lung Center

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Mississippi

Jackson, Mississippi, United States

Pinehurst Medical Clinic

Pinehurst, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Temple University

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

CHI Memorial Research Center

Chattanooga, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

JPS Health Network, Fort Worth

Fort Worth, Texas, United States

Houston Methodist

Houston, Texas, United States

Virginia Commonwealth University Health

Richmond, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Klinik Floridsdorf - Abteilung für Innere Medizin und Pneumologie

Vienna, , Austria

Charité Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, , Germany

Ruhrlandklinik Essen

Essen, , Germany

Thoraxklinik Heidelberg

Heidelberg, , Germany

ASST Spedali Civili Hospital

Brescia, , Italy

Royal Brompton Hospital

London, , United Kingdom

Countries

United States; Austria; Germany; Italy; United Kingdom

References

Krimsky WS, VanderLaan PA, Iding JS, Hunter DW, Hatton BA, Bannan B, Kim V. A quantitative method for assessing treatment-related changes within the airway mucosa in patients with chronic bronchitis. Respir Med. 2025 Jan;236:107889. doi: 10.1016/j.rmed.2024.107889. Epub 2024 Nov 28.

Reference Type: DERIVED

PMID: 39615802 (View on PubMed)

Other Identifiers

CSP-00006

Identifier Type: -

Identifier Source: org_study_id