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Targeted Lung Denervation for Patients With Moderate to Severe COPD — AIRFLOW  

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official 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.

Clinical Trial Summary

The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a similar safety profile and improved physiological and functional outcomes to a sham-control.

Clinical Trial Description

A prospective, sequential two phase multicenter, randomized double-blind, safety, & feasibility study. The goal of AIRFLOW-1 will be to compare two energy doses and select the optimal energy dose to be utilized in AIRFLOW-2. The goal of AIRFLOW-2 is to compare the optimal energy dose to a sham control. All subjects will be followed for a minimum of 3 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02058459
Study type Interventional
Source Nuvaira, Inc.
Contact
Status Completed
Phase N/A
Start date August 4, 2014
Completion date June 16, 2020
View Details
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