AIRFLOW-1
Research type
Research Study
Full title
A Sequential Two Phase Multicenter, Randomized Study to Optimize Dose Selection and Evaluate Safety After Treatment with the Holaira™ Lung Denervation System in Patients with Moderate to Severe COPD.
IRAS ID
155911
Contact name
Pallav Shah
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 10 months, 30 days
Research summary
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 ablated 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. This is a randomised controlled trial comparing two different doses of TLD to a sham control procedure. The primary outcome is safety outcomes with measures of lung function, exercise capacity and quality of life being measured as secondary outcomes. Patients will be enrolled for 1 year although there will be an interim analysis at 6 months where control patients will be able to cross over to active treatment. Patients will continue follow up for three years in total.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
14/EE/1193
Date of REC Opinion
22 Dec 2014
REC opinion
Further Information Favourable Opinion