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

A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients With COPD

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Bronchitis
• Intervention / Treatment: Device: RheOx Bronchial Rheoplasty; Device: Sham Procedure

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brett Bannan; Phone Number: 408-623-8104; Email: brett@galatherapeutics.com
• Study Contact Backup: Name: Cindy Holtz; Phone Number: 651-338-0457; Email: choltz@galatherapeutics.com

Study Locations

• Austria
  • Vienna, Austria, 1210
    • Klinik Floridsdorf - Abteilung für Innere Medizin und Pneumologie
• Germany
  • Berlin, Germany, 13353
    • Charité Universitätsmedizin Berlin, Campus Virchow Klinikum
  • Essen, Germany, 45239
    • Ruhrlandklinik Essen
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg
• Italy
  • Brescia, Italy, 25123
    • ASST Spedali Civili Hospital
• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Norton Thoracic
    • Scottsdale, Arizona, United States, 85258
      • Honor Health
  • California
    • Bakersfield, California, United States, 93309
      • Syed M. Alam, MD Pulmonology (Bakersfield Heart)
    • Davis, California, United States, 95817
      • UC Davis Medical Center
    • Encinitas, California, United States, 92024
      • Scripps Health
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Torrance, California, United States, 90502
      • UCLA Harbor Lundquist Institute
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Tallahassee, Florida, United States, 32605
      • The Cardiac and Vascular Institute Research Foundation
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Peoria, Illinois, United States, 61637
      • OSF Saint Francis Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas School of Medicine
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minnesota Lung Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst Medical Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • CHI Memorial Research Center
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
  • Texas
    • Fort Worth, Texas, United States, 76104
      • JPS Health Network, Fort Worth
    • Houston, Texas, United States, 77030
      • Houston Methodist
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University Health
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RheOx Treatment	Device: 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.
Sham Comparator: Sham Procedure	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distal Airway Volume	Change from baseline distal airway volume (DAV) at expiration using HRCT scans	6 months
COPD Exacerbations	Rate of moderate and severe COPD exacerbations	12 months
Goblet Cell Hyperplasia	change from baseline in mean goblet cell hyperplasia score as determined from airway biopsy samples; the grading scale ranges from 0 to 3, where lower scores represent less goblet cell hyperplasia	1 month
Cough Frequency	change from baseline in cough frequency (coughs/hour in a 24-hour recording period)	6 and 12 months

Collaborators and Investigators

• Sponsor: Gala Therapeutics, Inc.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Acute Disease; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: CSP-00006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes