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

Chronic Bronchitis Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04677465
• Other study ID #: CSP-00006
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 7, 2021
• Est. completion date: October 2025

Study information

• Verified date: November 2022
• Source: Gala Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 270
• Est. completion date: October 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis

Intervention

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 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)

Locations

Country	Name	City	State
Austria	Klinik Floridsdorf - Abteilung für Innere Medizin und Pneumologie	Vienna
Germany	Charité Universitätsmedizin Berlin, Campus Virchow Klinikum	Berlin
Germany	Ruhrlandklinik Essen	Essen
Germany	Thoraxklinik Heidelberg	Heidelberg
Italy	ASST Spedali Civili Hospital	Brescia
United Kingdom	Royal Brompton Hospital	London
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Syed M. Alam, MD Pulmonology (Bakersfield Heart)	Bakersfield	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	CHI Memorial Research Center	Chattanooga	Tennessee
United States	UC Davis Medical Center	Davis	California
United States	Scripps Health	Encinitas	California
United States	JPS Health Network, Fort Worth	Fort Worth	Texas
United States	Houston Methodist	Houston	Texas
United States	University of Mississippi	Jackson	Mississippi
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Kansas School of Medicine	Kansas City	Kansas
United States	University of Southern California	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Minnesota Lung Center	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Tulane University Medical Center	New Orleans	Louisiana
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Norton Thoracic	Phoenix	Arizona
United States	Pinehurst Medical Clinic	Pinehurst	North Carolina
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University Health	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Honor Health	Scottsdale	Arizona
United States	The Cardiac and Vascular Institute Research Foundation	Tallahassee	Florida
United States	UCLA Harbor Lundquist Institute	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Gala Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Distal Airway Volume	Change from baseline distal airway volume (DAV) at expiration using HRCT scans	6 months
Secondary	COPD Exacerbations	Rate of moderate and severe COPD exacerbations	12 months
Secondary	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
Secondary	Cough Frequency	change from baseline in cough frequency (coughs/hour in a 24-hour recording period)	6 and 12 months