Active not recruitingNAINTERVENTIONAL

Evaluation of the Safety and Efficacy of TLD in Patients with COPD

This research study is investigating a new treatment called Targeted Lung Denervation (TLD) for people living with Chronic Obstructive Pulmonary Disease (COPD). The main goal is to find out if the TLD treatment is both safe and effective. Researchers want to see if it can help reduce the number of moderate or severe COPD flare-ups that patients experience, compared to those receiving standard excellent medical care. The study will also carefully check for any side effects and compare other measures of how well patients are doing over time. This will help understand if TLD could be a helpful new option for managing COPD.

At a glance

Status

Active not recruiting

Phase

Sponsor

Nuvaira, Inc.

Enrolment target

464

Start

23 May 2019

Estimated completion

01 Sep 2028

COPD

What is this study about?

This study is looking into a new treatment called Targeted Lung Denervation (TLD) for people who have Chronic Obstructive Pulmonary Disease, often known as COPD. COPD is a common lung condition that makes it difficult to breathe. This research aims to understand if TLD is a safe and effective way to help people with COPD, especially by reducing times when their symptoms get much worse, known as 'exacerbations' or 'flare-ups'. These flare-ups can be very serious and sometimes lead to hospital stays.

In this study, some participants will receive the TLD treatment, while others will have a 'sham procedure'. A sham procedure is like a fake treatment, designed to make sure that any benefits seen are truly from the TLD treatment itself and not just from people expecting to feel better. This is a common and important part of medical research to get clear and reliable results. Everyone in the study will also continue to receive the best possible medical care for their COPD.

The researchers will closely watch how often participants have COPD flare-ups and will also monitor their overall health and any side effects over a long period. By comparing the group who had the TLD treatment with the group who had the sham procedure, the study hopes to show if TLD could be a valuable new option to help people with COPD manage their condition better and have fewer serious flare-ups.

Key takeaways

This study evaluates a new treatment for COPD called TLD.
It aims to reduce COPD flare-ups and improve breathing.
Participants will receive either TLD or a sham procedure.
All participants will continue to receive excellent standard medical care.
The study lasts for at least 12 months after the procedure.

Who may be eligible?

To be considered for this study, you need to be at least 40 years old. If you are a woman who could have children, you must not be pregnant or breastfeeding and must agree not to become pregnant during the study. You also need to have a history of smoking for at least 10 'pack years' (this is a way doctors measure how much someone has smoked over time).

It's important that you haven't smoked or used any other inhaled substances, like vapes or cannabis, for at least two months before joining the study, and you must agree not to start again throughout the study. Your oxygen levels at rest should be at least 89% when breathing room air, and you should have a certain score on a COPD assessment test (CAT score of 10 or more). You must also have a clear diagnosis of COPD with specific lung function test results.

Crucially, you need to have a history of at least two moderate COPD flare-ups or at least one severe flare-up that led to a hospital stay within the past year. At least one of these flare-ups must have happened while you were already receiving the best standard medical care for your COPD. You must also be able to stop certain blood-thinning medications for a short time around the procedure if needed, and be able to attend all clinic visits and complete all required tests.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 40 years old or older?
Have you stopped smoking or using inhaled substances for at least two months?
Do you have a documented history of significant COPD flare-ups in the last year?
Are you currently receiving excellent medical care for your COPD?
Are you able to attend all study appointments and complete required tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the best standard medical care for your COPD. The study involves either undergoing the TLD treatment or a 'sham' procedure, which is like a dummy treatment to help researchers compare results fairly. Both procedures involve a bronchoscope, a thin tube with a camera that goes into your lungs.

You will have several visits to the clinic for various tests and assessments. These may include breathing tests, physical checks, and questionnaires about your health and how you feel. You might also need to take specific medications before or during the study, such as antibiotics. The team will carefully explain the schedule of appointments and procedures to you. You will be followed up for a significant period to monitor your progress and any effects of the treatment, usually for at least 12 months.

Potential risks and benefits

Like all medical procedures and research studies, there are potential benefits and risks. The potential benefit of taking part is that the TLD treatment might reduce your COPD flare-ups and improve your breathing and quality of life. However, as this is a research study, there's no guarantee you will receive the active treatment or that it will benefit you. There might be side effects or complications from the procedure itself or the medications, and the research team will explain these to you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (33)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama at Birmingham (UAB) Lung Health Center
Verified postcode
Birmingham, United States
HonorHealth
Verified postcode
Phoenix, United States
UC Davis
Verified postcode
Sacramento, United States
Harbor UCLA
Verified postcode
Torrance, United States
Ascension St. Vincent's
Verified postcode
Jacksonville, United States
University of Chicago
Verified postcode
Chicago, United States
Suburban Lung Associates
Verified postcode
Elk Grove Village, United States
University of Louisville
Verified postcode
Louisville, United States
Lahey Hospital & Medical Center
Verified postcode
Burlington, United States
University of Michigan
Verified postcode
Ann Arbor, United States
Spectrum Health Medical Group
Verified postcode
Grand Rapids, United States
Washington University
Verified postcode
St Louis, United States

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease, a common lung condition that causes breathing difficulties through narrowed airways.

What is Targeted Lung Denervation (TLD)?

TLD is a new treatment that aims to improve breathing by targeting specific nerves in the airways that may contribute to COPD symptoms.

What is a 'sham procedure'?

A sham procedure is a control treatment that looks like the real treatment but doesn't have the active component, used to ensure fair comparison in studies.

Will I know if I get the real treatment or the sham one?

No, you won't know if you receive the active TLD treatment or the sham procedure as this is a 'blinded' study, which helps make the results more reliable.

How long will I be in the study?

You will be followed up for at least 12 months after the procedure to check your health and the treatment’s effects.