A Multicenter, Randomised, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira Lung Denervation System in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Duration of Study in the UK
6 years, 0 months, 1 days
Chronic obstructive pulmonary disease (COPD) affects nearly three million people in the UK. It causes debilitating symptoms of breathlessness and exercise intolerance. One of the major causes of these symptoms is the narrowing of the airways within the lungs. This occurs due to inflammation and contraction of the smooth muscle lining the airways. The smooth muscle contraction is controlled by the vagus nerve. Currently we use medications such as tiotropium to help open up the airways by blocking the effect of the vagus nerve. This isn't effective for everyone and means taking inhalers every day. An operation to cut the vagus nerve improves lung function by stopping the nerve from causing contraction of the smooth muscle. However this is not routinely performed as it has significant risks and will affect other organs. The Holaira Targeted Lung Denervation (TLD) system is a minimally invasive way to disconnect the branches of the vagus nerve that only supply the lung. The intention is that by removing the effect of the vagus nerve that there will be a sustained improvement in lung function and symptoms by helping open up narrowed airways. TLD Therapy has the potential to provide long-term sustained improvements in lung function which are similar to the transient peak effectiveness of inhaled drugs such as tiotopium.
So far, there has been 2 pilot studies (IPS-1 and IPS-2) as well as a multi-phase, multi-centre trial (AIRFLOW-1 and AIRFLOW-2). The primary aim of this study is to determine the efficacy of TLD on reducing COPD exacerbations. Previous trials were not designed to measure changes in COPD exacerbation frequency. This trial has been designed with this study outcome in mind. We will also be assessing ongoing safety and efficacy data.
This is a prospective, multi-center, randomized, sham-controlled, double-blind (subject and follow-up assessor(s)), safety and efficacy study.
East of England - Cambridge East Research Ethics Committee
Date of REC Opinion
2 May 2019
Further Information Favourable Opinion