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

  • STATUS
    Recruiting
  • End date
    Jan 9, 2024
  • participants needed
    270
  • sponsor
    Gala Therapeutics, Inc.
Updated on 9 August 2021
COPD
cough
bronchodilator
cigarette smoke

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.

Details
Condition Chronic bronchitis
Treatment Sham Procedure, RheOx Bronchial Rheoplasty
Clinical Study IdentifierNCT04677465
SponsorGala Therapeutics, Inc.
Last Modified on9 August 2021

Eligibility

Yes No Not Sure

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
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