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Targeted Lung Denervation for Patients With Moderate to Severe COPD | Clinical Trials | Clareo Health

COMPLETEDNA

Targeted Lung Denervation for Patients With Moderate to Severe COPD

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.

NCT02058459•Nuvaira, Inc.

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of COPD with 30% ≤ FEV1 \< 60% and FEV1/FVC \<70% (post-bronchodilator);
•Patient ≥ 40 and ≤ 75 years of age at the time of consent;
•The patient has no child bearing potential or a negative pregnancy test (serum or urine), if applicable;
•Smoking history of at least 10 pack years;
•Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study;
•Participated in a pulmonary rehabilitation program or engaged in regular physical activity under professional supervision in the past 12 months;

Exclusion Criteria

•Has been less than 6 weeks following the resolution of a COPD exacerbation or active lower respiratory infection (eg. pneumonia);
•History of recurrent respiratory infections and/or COPD exacerbations (more than 2 hospitalizations within 1 year of enrollment);
•Prior lung or chest procedure (eg. lung transplant, LVRS, BLVR, lung implant, metal stent, valves, coils, median sternotomy, bullectomy, segmentectomy, or lobectomy);
•Documented history of asthma diagnosed with onset \<30 years of age, cystic fibrosis, paradoxical vocal cord motion, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, severe interstitial lung disease or active tuberculosis;
•Pulmonary nodule requiring follow-up or intervention unless proven benign;
•Daily use of \>10 mg of prednisone or its equivalent at the time of enrollment;

Locations (18)

AKH Allgemeines Krankenhaus der Stadt Linz GmbH

Linz, Austria

Otto-Wagner-Spital

Vienna, Austria

CHU Saint Pierre

Brussels, Belgium

University Hospital Leuven

Leuven, Belgium

CHU de Grenoble

Grenoble, France

CHU de Lille

Lille, France

CHU de Paris - Hopital Bichat Claude Bernard

Paris, France

CHU de Reims

Reims, France

CHU de Strasbourg

Strasbourg, France

Charite-Universitatsmedizin Berlin

Berlin, Germany

Key Dates

Start Date

August 4, 2014

Primary Completion Date

January 26, 2018

Completion Date

June 16, 2020

Last Updated

April 13, 2022

Enrollment

128

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Holaira™ Lung Denervation System with energy delivery

DEVICE

Holaira™ Lung Denervation System without energy delivery

DEVICE

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

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Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

Mindful-Breath for People With COPD

NCT07195838

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Targeted Lung Denervation for Patients With Moderate to Severe COPD

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A