Bronchial rheoplasty for chronic bronchitis: 2-year results from a US feasibility study with RheOx

Frank C Sciurba; Mark T Dransfield; Victor Kim; Nathaniel Marchetti; Alejandro Comellas; Douglas Kyle Hogarth; Adnan Majid

doi:10.1136/bmjresp-2023-001710

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Bronchial rheoplasty for chronic bronchitis: 2-year results from a US feasibility study with RheOx

Journal article

Open access

Peer reviewed

Bronchial rheoplasty for chronic bronchitis: 2-year results from a US feasibility study with RheOx

Frank C Sciurba, Mark T Dransfield, Victor Kim, Nathaniel Marchetti, Alejandro Comellas, Douglas Kyle Hogarth and Adnan Majid

BMJ open respiratory research, Vol.10(1), e001710

12/26/2023

DOI: 10.1136/bmjresp-2023-001710

PMCID: PMC10753755

PMID: 38151258

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Abstract

Chronic bronchitis (CB), a phenotype of chronic obstructive pulmonary disease (COPD) characterised by persistent cough and mucus hypersecretion, is associated with poor outcomes despite guideline-based treatment. Bronchial rheoplasty (BR) with the RheOx system delivers non-thermal pulsed electric fields to the lower airway epithelium and submucosa to reduce mucus producing cells. Early phase clinical trials including 1-year follow-up have demonstrated reduction in airway goblet cell hyperplasia and improvement in CB symptoms. The current multicentre observational BR study enrolled 21 patients with CB at six centres in the USA, with bilateral treatment and 2-year follow-up. Entry criteria included elevated cough and sputum scores from COPD Assessment Test (CAT) and forced expiratory volume in one second<80% predicted. Safety was assessed by serious adverse event (SAE) incidence through 24 months. Clinical utility was evaluated using changes in the CAT, the St. George's Respiratory Questionnaire (SGRQ) and by comparing exacerbation rates before and following intervention. No procedure-related or device-related SAEs occurred. Mean (SD) changes from baseline in CAT at 12 and 24 months were -9.0 (6.7) (p<0.0001) and -5.6 (7.1) (p<0.0047) and in SGRQ were -16.6 (13.2) (p<0.0001) and -11.8 (19.2) (p<0.0227), respectively. There was a 34% reduction in moderate and a 64% reduction in severe COPD exacerbation events compared with the year prior to treatment. This study extends the findings from previous feasibility studies, demonstrating that BR can be performed safely and may significantly improve symptoms and health-related quality of life for patients with CB through 24 months. NCT03631472.

Feasibility Studies

Quality of Life

Bronchitis, Chronic - surgery

Disease Progression

Humans

Pulmonary Disease, Chronic Obstructive - drug therapy

Details

Title: Subtitle: Bronchial rheoplasty for chronic bronchitis: 2-year results from a US feasibility study with RheOx
Creators: Frank C Sciurba - University of Pittsburgh
Mark T Dransfield - University of Alabama at Birmingham
Victor Kim - Temple University
Nathaniel Marchetti - Temple University
Alejandro Comellas - University of Iowa
Douglas Kyle Hogarth - University of Chicago Medical Center
Adnan Majid - Beth Israel Deaconess Medical Center
Resource Type: Journal article
Publication Details: BMJ open respiratory research, Vol.10(1), e001710
DOI: 10.1136/bmjresp-2023-001710
PMID: 38151258
PMCID: PMC10753755
NLM abbreviation: BMJ Open Respir Res
eISSN: 2052-4439
Grant note: name: Gala Therapeutics Inc., award: CS003
Language: English
Date published: 12/26/2023
Academic Unit: Pulmonary, Critical Care, and Occupational Medicine; ICTS; Internal Medicine
Record Identifier: 9984535659802771

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