Zephyr Valve Can Help Emphysema Patients Breathe Better Long-term
The Zephyr Endobronchial Valve significantly improved lung function and quality of life for at least two years in people with emphysema, a severe form of chronic obstructive pulmonary disease (COPD), according to new clinical trial data.
“These long-term data further demonstrate that our Zephyr Valve is a safe, effective, and lasting treatment option for patients with severe COPD/emphysema,” Glen French, president and CEO of Pulmonx, which markets the device, said in a press release.
Trial findings were shared by the company in a presentation, titled “Long-Term Follow-up of Severe Emphysema Patients Treated with Zephyr Valves in the Multicenter, Randomized TRANSFORM Study,” at the American Thoracic Society 2021 International Conference, held online May 14–19.
The Zephyr Valve is a medical device approved in the U.S. for patients with severe emphysema who have difficulty breathing. The device can be used for bronchoscopic lung volume reduction (BLVR), a non-surgical treatment that blocks off diseased parts of the lungs so that healthier parts can take in more air, making breathing easier.
Data from a previous Pulmonx-sponsored trial, called LIBERATE (NCT01796392), showed that BLVR using the Zephyr Valve can reduce breathlessness, increase exercise capacity, and improve quality of life in people with emphysema. The device is currently covered by several major insurers in the U.S.
At the conference, the company presented new data from another clinical trial, called TRANSFORM (NCT02022683), that assessed the effectiveness of the Zephyr Valve in patients with severe emphysema.
In TRANSFORM, 97 patients (58 men and 39 women, with a mean average age of 64.3 years) were randomized to receive BLVR using the Zephyr Valve plus best standard care, or best standard care alone.
Previous data from the trial indicated that, six months after treatment, participants given BLVR had significantly better lung function and quality of life than those treated with best standard care alone.
Newly presented data came from participants for whom longer-term data was available, including 48 patients with complete data up to 12 months, 40 with data up to 18 months, and 39 with data up to two years.
Broadly, findings indicated that improvements seen at six months were maintained at later timepoints. For example, forced expiratory volume in one second (FEV1), a measure of lung function, was on average 20.51% higher at 12 months, compared with values seen at the study’s start (baseline). After two years, FEV1 was on average 12.67% higher than baseline values.
Other measures generally followed the same trend. For instance, scores on the St. George’s Respiratory Questionnaire — a tool that assesses the impact of disease on a person’s overall health, daily life, and well-being — were about nine points lower (better) at 12, 18, and 24 months, compared to values at the trial’s start.
Statistically significant improvements in exercise capacity, as measured by the six-minute-walk test, were also seen at 12 and 18 months. The test measures the distance a person is able to walk in six minutes.
These sustained improvements stand in contrast to the normal course of emphysema, where lung function and life quality normally deteriorate over time, the researchers said.
“Historically we have not had good treatment options for patients with severe disease who struggle to breathe even with medication adherence,” said Dirk-Jan Slebos, MD, PhD, professor at the University of Groningen in The Netherlands, who presented the findings at the conference. “This new data on the lasting benefits of endobronchial valves is significant because it means we now have a viable option to give patients sustained improvements, despite the progressive nature of this disease.”
“There is no cure for COPD/emphysema, but to have a bronchoscopic treatment that can increase patients’ quality of life for years is a great advancement,” he said.