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

Primary Purpose

Chronic Bronchitis

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RheOx Bronchial Rheoplasty
Sham Procedure
Sponsored by
Gala Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Bronchitis focused on measuring COPD

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Norton Thoracic
  • Honor Health
  • Syed M. Alam, MD Pulmonology (Bakersfield Heart)
  • UC Davis Medical Center
  • Scripps Health
  • University of Southern California
  • UCLA Harbor Lundquist Institute
  • University of Colorado
  • Mayo Clinic
  • The Cardiac and Vascular Institute Research Foundation
  • Emory University
  • OSF Saint Francis Medical Center
  • University of Kansas School of Medicine
  • Tulane University Medical Center
  • Beth Israel Deaconess Medical Center
  • Lahey Hospital and Medical Center
  • University of Michigan
  • Minnesota Lung Center
  • Mayo Clinic
  • University of Mississippi
  • Pinehurst Medical Clinic
  • University of Pennsylvania
  • Temple University
  • University of Pittsburgh Medical Center
  • CHI Memorial Research Center
  • Vanderbilt University Medical Center
  • JPS Health Network, Fort Worth
  • Houston Methodist
  • Virginia Commonwealth University Health
  • Medical College of Wisconsin
  • Klinik Floridsdorf - Abteilung für Innere Medizin und Pneumologie
  • Charité Universitätsmedizin Berlin, Campus Virchow Klinikum
  • Ruhrlandklinik Essen
  • Thoraxklinik Heidelberg
  • ASST Spedali Civili Hospital
  • Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RheOx Treatment

Sham Procedure

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Distal Airway Volume
Change from baseline distal airway volume (DAV) at expiration using HRCT scans
COPD Exacerbations
Rate of moderate and severe COPD exacerbations
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
Cough Frequency
change from baseline in cough frequency (coughs/hour in a 24-hour recording period)

Full Information

First Posted
December 16, 2020
Last Updated
June 26, 2023
Sponsor
Gala Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04677465
Brief Title
Clinical Study of the RheOx Bronchial Rheoplasty System in Treating the Symptoms of Chronic Bronchitis
Acronym
RheSolve
Official Title
A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 7, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gala Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Bronchitis
Keywords
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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%)
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RheOx Treatment
Arm Type
Experimental
Arm Title
Sham Procedure
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
RheOx Bronchial Rheoplasty
Intervention Description
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
Intervention Name(s)
Sham Procedure
Intervention Description
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)
Primary Outcome Measure Information:
Title
COPD Assessment Test (CAT) Score
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Distal Airway Volume
Description
Change from baseline distal airway volume (DAV) at expiration using HRCT scans
Time Frame
6 months
Title
COPD Exacerbations
Description
Rate of moderate and severe COPD exacerbations
Time Frame
12 months
Title
Goblet Cell Hyperplasia
Description
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
Time Frame
1 month
Title
Cough Frequency
Description
change from baseline in cough frequency (coughs/hour in a 24-hour recording period)
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. Patient has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines). Patient is pregnant, nursing, or planning to get pregnant during study duration. Patient is currently participating in another clinical study involving an investigational product
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Sciurba, MD
Organizational Affiliation
UPMC; Division of Pulmonary and Critical Care Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arschang Valipour, MD
Organizational Affiliation
Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology; Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Norton Thoracic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Honor Health
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Syed M. Alam, MD Pulmonology (Bakersfield Heart)
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
UC Davis Medical Center
City
Davis
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Scripps Health
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Harbor Lundquist Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
The Cardiac and Vascular Institute Research Foundation
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
University of Kansas School of Medicine
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Tulane University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Minnesota Lung Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Pinehurst Medical Clinic
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
CHI Memorial Research Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
JPS Health Network, Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Commonwealth University Health
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Klinik Floridsdorf - Abteilung für Innere Medizin und Pneumologie
City
Vienna
ZIP/Postal Code
1210
Country
Austria
Facility Name
Charité Universitätsmedizin Berlin, Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Ruhrlandklinik Essen
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Thoraxklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
ASST Spedali Civili Hospital
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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