A new endoscopic technology for treating chronic bronchitis in patients in COPD has been shown to be feasible, well tolerated and safe in an international trial, including sites in Australia.
And there were early signals for effectiveness in the first in-human study.
Presented at the 2019 ERS Congress in Madrid, the RheOxTM bronchial rheoplasty uses a non-thermal pulsed electric field to reduce mucous-producing cells in the airways but leave the extracellular matrix intact.
Associate Professor Arschang Valipour from the Karl-Lansteiner Institute for Lung Research and Pulmonary Oncology in Austria, told the Congress the single arm, prospective multicentre feasibility study enrolled 30 patients at six sites including Australia.
Patients had a productive cough for at least three months in the previous two years, post-bronchodilator FEV1 >30%, a ≥10 pack-year smoking history, a St George’s Respiratory Questionnaire (SGRQ) ≥25 Points and COPD Assessment Test (CAT) ≥ 10 points.
He said patients had a high symptom burden despite relatively preserved lung function.
The first lung was treated then the second lung a month later. The procedure, performed under general anaesthesia, were show to be feasible in all cases. The device was activated a mean of 43 times during each procedure.
Median hospital stay was one day.
Associate Professor Valipour said there were no device related safety concerns in the immediate recovery period or at six-months follow-up. There was one episode of early mucosal scarring and one case of pneumonia related to the procedure.
Histopathology on endobronchial cryobiopsies showed goblet cell hyperplasia reduced by 39% from baseline to day 120.
Symptoms, both cough and sputum production, reduced at both three months and six months follow-up and there were clinically meaningful improvements in SGRQ and CAT.
As expected, there was no change in lung function.
Associate Professor Valipour told the Congress it was a very promising technology, which avoided the damage to the airway mucosa seen in thermal technologies such as bronchial thermoplasty.
“And that’s why I believe a non-thermal technology has much more potential because it doesn’t really create a severe injury to the airways,” he told the limbic.
“To achieve the same results without thermal energy and damage to the airways is certainly a much more straightforward way to move forward.”
He said there was the potential for re-treatment or sequential treatment in patients however it was essential they stopped smoking.
The study is now following up patients at 12 months with a prospective sham-controlled study due to start in 2020.
Australian co-investigators include Professor Alvin Ing, Associate Professor Lou Irving, Dr Daniel Steinfort and Dr Eli Dabscheck.