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

Gala Therapeutics, Inc.36 sites in 5 countries270 target enrollmentApril 7, 2021

ConditionsChronic Bronchitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Bronchitis
Sponsor: Gala Therapeutics, Inc.
Enrollment: 270
Locations: 36
Primary Endpoint: COPD Assessment Test (CAT) Score
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 7, 2021

End Date

October 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Gala Therapeutics, Inc.

Responsible Party

Sponsor

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 ≥
•Patient has an SGRQ score ≥
•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.
•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.

Outcomes

Primary Outcomes

COPD Assessment Test (CAT) Score

Time Frame: 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