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

Sponsor

Gala Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04677465

Collaborator

(none)

270

Enrollment

Locations

Arms

53.8

Anticipated Duration (Months)

6.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Bronchitis	Device: RheOx Bronchial Rheoplasty Device: Sham Procedure	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

270 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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%)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:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 7, 2021

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

COPD Assessment Test (CAT) Score [6 months]
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 [6 months]
Change from baseline distal airway volume (DAV) at expiration using HRCT scans
COPD Exacerbations [12 months]
Rate of moderate and severe COPD exacerbations
Goblet Cell Hyperplasia [1 month]
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 [6 and 12 months]
change from baseline in cough frequency (coughs/hour in a 24-hour recording period)

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 < 0.7.
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
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, neuro-stimulation devices).
Patient has a history of arrhythmia within past two years which includes tachy-atrial arrhythmias, any ventricular tachy-arrhythmias, or sinus bradycardia with heart rate less than 45 beats per minute.
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 20% 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Norton Thoracic	Phoenix	Arizona	United States	85013
3	Honor Health	Scottsdale	Arizona	United States	85258
4	Syed M. Alam, MD Pulmonology (Bakersfield Heart)	Bakersfield	California	United States	93309
5	UC Davis Medical Center	Davis	California	United States	95817
6	Scripps Health	Encinitas	California	United States	92024
7	University of Southern California	Los Angeles	California	United States	90033
8	UCLA Harbor Lundquist Institute	Torrance	California	United States	90502
9	University of Colorado	Aurora	Colorado	United States	80045
10	Mayo Clinic	Jacksonville	Florida	United States	32224
11	The Cardiac and Vascular Institute Research Foundation	Tallahassee	Florida	United States	32605
12	Emory University	Atlanta	Georgia	United States	30322
13	OSF Saint Francis Medical Center	Peoria	Illinois	United States	61637
14	University of Iowa	Iowa City	Iowa	United States	52242
15	University of Kansas School of Medicine	Kansas City	Kansas	United States	66160
16	University of Louisville-Division of Pulmonary, Critical Care & Sleep Disorders Medicine	Louisville	Kentucky	United States	40202
17	Tulane University Medical Center	New Orleans	Louisiana	United States	70112
18	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
19	Lahey Hospital and Medical Center	Burlington	Massachusetts	United States	01805
20	University of Michigan	Ann Arbor	Michigan	United States	48109
21	Minnesota Lung Center	Minneapolis	Minnesota	United States	55407
22	Mayo Clinic	Rochester	Minnesota	United States	55905
23	Montefiore Medical Center	Bronx	New York	United States	10467
24	Pinehurst Medical Clinic	Pinehurst	North Carolina	United States	28374
25	The University of Ohio State Medical Center	Columbus	Ohio	United States	43221
26	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
27	Temple University	Philadelphia	Pennsylvania	United States	19140
28	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
29	CHI Memorial Research Center	Chattanooga	Tennessee	United States	37404
30	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212
31	JPS Health Network, Fort Worth	Fort Worth	Texas	United States	76104
32	Houston Methodist	Houston	Texas	United States	77030
33	Virginia Commonwealth University Health	Richmond	Virginia	United States	23298
34	PeaceHealth Southwest Washington Medical Center	Vancouver	Washington	United States	98664
35	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
36	Klinik Floridsdorf - Abteilung für Innere Medizin und Pneumologie	Vienna		Austria	1210
37	Charité Universitätsmedizin Berlin, Campus Virchow Klinikum	Berlin		Germany	13353
38	Ruhrlandklinik Essen	Essen		Germany	45239
39	Thoraxklinik Heidelberg	Heidelberg		Germany	69126

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gala Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT04677465

Other Study ID Numbers:

CSP-00006

First Posted:

Dec 21, 2020

Last Update Posted:

Jul 12, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Gala Therapeutics, Inc.

COPD

Additional relevant MeSH terms:

Bronchitis

Bronchitis, Chronic

Acute Disease

Study Results

No Results Posted as of Jul 12, 2022