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

NCT04677465 | Unknown DMC FDA Device

• 1 other identifier: CSP-00006
• Study Type: interventional
• Target: 270
• Locations: 5 countries
• Sites: 37

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

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• COPD Assessment Test (CAT) Score

  Mean change from baseline in the COPD Assessment Test (CAT) total score, the total CAT score ranges from 0 to 40, where lower scores represent lower symptom burden

  6 months

Secondary Outcomes (4)

• Distal Airway Volume

  6 months

• COPD Exacerbations

  12 months

• Goblet Cell Hyperplasia

  1 month

• Cough Frequency

  6 and 12 months

Study Arms (2)

RheOx Treatment

EXPERIMENTAL

Device: RheOx Bronchial Rheoplasty

Sham Procedure

SHAM COMPARATOR

Device: Sham Procedure

Interventions

RheOx Bronchial Rheoplasty 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.

RheOx Treatment

Sham Procedure 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)

Sham Procedure

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is at least 35 years of age.
• 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.
• Patient has a CAT score ≥ 10.
• Patient has an SGRQ score ≥ 25.
• 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.
• Patient has FEV1/FVC \< 0.70.
• Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥ 30%.
• 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.
• Patient has a cigarette smoking history of at least ten pack years.
• 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

You may not qualify if:

• Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
• Patient has a steroid-dependent condition requiring \>10 mg of oral corticosteroid per day.
• Patient has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator) that cannot be turned off during the procedure.
• 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.
• Patient has unresolved lung cancer.
• Patient has a pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.
• 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.
• 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.
• Patient has asthma based on Global Initiative for Asthma (GINA) criteria.
• Patient has clinically significant bronchiectasis influencing the patient's clinical symptoms of cough and phlegm.
• Patient has actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
• Patient is unable to walk over 225 meters in 6 minutes.
• 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).
• Patient has uncontrolled GERD.
• Patient has known severe pulmonary hypertension.

Sponsors & Collaborators

• Gala Therapeutics, Inc.: lead

Study Sites (37)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Norton Thoracic

Phoenix, Arizona, 85013, United States

Location

Honor Health

Scottsdale, Arizona, 85258, United States

Location

Syed M. Alam, MD Pulmonology (Bakersfield Heart)

Bakersfield, California, 93309, United States

Location

UC Davis Medical Center

Davis, California, 95817, United States

Location

Scripps Health

Encinitas, California, 92024, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

UCLA Harbor Lundquist Institute

Torrance, California, 90502, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

The Cardiac and Vascular Institute Research Foundation

Tallahassee, Florida, 32605, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

University of Kansas School of Medicine

Kansas City, Kansas, 66160, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Minnesota Lung Center

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Mississippi

Jackson, Mississippi, 39216, United States

Location

Pinehurst Medical Clinic

Pinehurst, North Carolina, 28374, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

CHI Memorial Research Center

Chattanooga, Tennessee, 37404, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

JPS Health Network, Fort Worth

Fort Worth, Texas, 76104, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University Health

Richmond, Virginia, 23298, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Klinik Floridsdorf - Abteilung für Innere Medizin und Pneumologie

Vienna, 1210, Austria

Location

Charité Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Ruhrlandklinik Essen

Essen, 45239, Germany

Location

Thoraxklinik Heidelberg

Heidelberg, 69126, Germany

Location

ASST Spedali Civili Hospital

Brescia, 25123, Italy

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39615802 DERIVED

MeSH Terms

Conditions

Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank Sciurba, MD

  UPMC; Division of Pulmonary and Critical Care Medicine

  PRINCIPAL INVESTIGATOR

• Arschang Valipour, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel group design randomizing patients in a 2:1 ratio to the treatment vs. sham group. Randomization will be blocked and stratified by site and FEV1 (\<50% vs. \>/= 50%)

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: April 7, 2021
• Primary Completion: May 1, 2024
• Study Completion: October 1, 2025
• Last Updated: June 27, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); US (31); AU (1); GB (1); IT (1)