The double-blind, randomised and sham-controlled trial will recruit up to 270 COPD patients with moderate to severe chronic bronchitis
Medical devices maker Gala Therapeutics has recruited first patients in its pivotal trial of RheOx bronchial rheoplasty system to treat chronic bronchitis.
Under the trial, the first patient procedures in the trial have been conducted by Dr Frank Sciurba at UPMC in Pittsburgh and Dr Patrick Whitten at OSF HealthCare Saint Francis Medical Center in Peoria, Illinois.
Chronic bronchitis is a phenotype of chronic obstructive pulmonary disease (COPD), which involves prolonged inflammation and excess mucus production in the lung airways that may lead to severe coughing spells, mucus, wheezing, chest pain and shortness of breath.
In 2019, Gala Therapeutics secured breakthrough device designation from the US Food and Drug Administration (FDA) for its RheOx system to deliver non-thermal pulsed energy to mucus-producing cells in the lung airways to improve the cough and mucus symptoms of chronic bronchitis.
Gala Therapeutics CEO Dr Jonathan Waldstreicher said: “Prior clinical studies using the first-of-its-kind RheOx system for chronic bronchitis have demonstrated compelling improvements in patient symptoms and quality of life.
“We are excited to begin the RheSolve pivotal trial, a key step in our pursuit to commercialize RheOx therapy to improve the lives of these patients.”
The RheSolve study is a double-blind, randomised and sham-controlled trial in COPD patients with moderate to severe chronic bronchitis, said the company.
Gala will randomise a total of 270 consenting participants in a 2:1 ratio to provide treatment using RheOx or a sham procedure.
The patients will be enrolled at up to 40 US and 10 international centres.
Gala’s study consists of a 12-month cross-over, at which point participants who secure the sham procedure and who meet certain criteria may be eligible to secure RheOx treatment.
The change from baseline to six months in patient-reported symptoms using the COPD Assessment Test is the primary efficacy endpoint.