Breakthrough lung ‘scaffolding’ treatment offers hope for emphysema patients in UK clinical trial

A pioneering clinical trial led by clinicians at Royal Brompton Hospital, part of Guy’s and St Thomas’ NHS Foundation Trust, has revealed promising early results for a new treatment option for people living with emphysema.

Emphysema is a form of chronic obstructive pulmonary disease (COPD) that damages the walls of the tiny air sacs in the lungs, known as alveoli. This damage leads to trapped air, breathlessness, and reduced quality of life. It is estimated (1) that around 1.7 million people in the UK have COPD.

In healthy lungs, the alveoli are elastic and springy, which helps them to inflate and allows for easy breathing. When the alveoli are damaged, most often by smoking or breathing in harmful substances, they lose their shape and break down. This causes the alveoli to merge into larger, less efficient spaces leading to trapped air, making it hard to breathe. The BREATHE-2 trial is testing an innovative airway scaffold—a tiny, self-expanding implant designed to release trapped air from overinflated areas of the lung.

Royal Brompton is the only UK hospital taking part in this global study, led by respiratory consultant Professor Pallav Shah and his team. Of the 60 patients enrolled worldwide, 21 are from Royal Brompton, making them among the first in the world to potentially benefit from this cutting-edge approach.

All patients enrolled to the trial have severe emphysema and trapped air. Each patient underwent a bronchoscopy, a minimally invasive procedure, to place up to three scaffolds in each lung. The aim of the trial was to assess if there were any serious complications within 6 months (safety), if the scaffolds could be placed successfully (feasibility) and whether there were improvements in the patient’s breathing, symptoms and overall quality of life (effectiveness).

Although this is still an early-stage study (6 months), the results so far are promising, with improved lung function and the amount of trapped air in the lungs decreasing by about 800ml at both 3 and 6 months. Participants also reported better breathing, quality of life, and exercise ability.

Professor Shah said: “This early study shows promise in a group of patients with emphysema who had no treatment options, and, in the majority, they experience dramatic improvements in their quality of life. In the next study, we have to see if these benefits are maintained in comparison to a placebo group.”

The trial is ongoing, with plans to recruit up to 250 participants across Europe and the USA in the FDA Pivotal Study – BREATHE-3. Full results from the initial phase of BREATHE-2 were published in the American Journal of Respiratory and Critical Care Medicine.

Details of the BREATHE-3 study can be found at - Study Details | NCT06891755 | Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3 | ClinicalTrials.gov