Targeted Lung Denervation for Patients With Moderate to Severe COPD

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Device: Holaira™ Lung Denervation System with energy delivery; Device: Holaira™ Lung Denervation System without energy delivery

• Registration Number: NCT02058459
• Lead Sponsor: Nuvaira, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-10
• Study Start: 2014-08-04
• Primary Completion: 2018-01-26
• Study Completion: 2020-06-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Targeted Lung Denervation	Holaira™ Lung Denervation System with energy delivery	active targeted lung denervation
Sham-Control	Holaira™ Lung Denervation System without energy delivery	non-active targeted lung denervation

Primary Outcome Measures

Name	Time	Method
AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 6.5 months	3-6.5 months	Respiratory adverse events is defined as: worsening bronchitis, worsening dyspnea, common cold, COPD exacerbation, influenza, pneumonia, respiratory infection, respiratory failure, tachypnea and wheezing. Subjects may have reported more than one type of respiratory adverse event.

Secondary Outcome Measures

Name	Time	Method
Device Success	6 months	Device success is defined as ability to deliver the test device to its intended locations, provide complete circumferential treatment and removal of the test device without the report of an adverse event during the procedure.
Spirometry measures	3 years	Measures include: FEV1, FVC, FEV1/FVC
Procedure Success	Through discharge	Procedure Success is defined as device success without the report of an adverse event through hospital discharge.
Adverse events over 3 years	3 years	The assessment of safety will be based on reporting of adverse events, particularly those adverse events that are respiratory in origin.
CT Scan assessment	3 years
Change in Functional testing: Cycle Ergometry & 6MWT	3 years
Heath-related Quality of Life (SGRQ-C & EQ-5D)	3 years
Plethysmography measures	3 years	Measures include Raw, TLC, IC, ITGW

Trial Locations

Locations (18)

Otto-Wagner-Spital; 🇦🇹 Vienna, Austria

AKH Allgemeines Krankenhaus der Stadt Linz GmbH; 🇦🇹 Linz, Austria

CHU de Strasbourg; 🇫🇷 Strasbourg, France

Charite-Universitatsmedizin Berlin; 🇩🇪 Berlin, Germany

University Hospital Leuven; 🇧🇪 Leuven, Belgium

CHU de Lille; 🇫🇷 Lille, France

CHU Saint Pierre; 🇧🇪 Brussels, Belgium

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU de Reims; 🇫🇷 Reims, France

CHU de Paris - Hopital Bichat Claude Bernard; 🇫🇷 Paris, France

Asklepios-Fachkliniken; 🇩🇪 Gauting, Germany

Universitatklinikum Bonn; 🇩🇪 Bonn, Germany

Ruhrlandklinik - West German Lung Center; 🇩🇪 Essen, Germany

Thoraxklinik Heidelberg; 🇩🇪 Heidelberg, Germany

Klinikverbund Kempten-Oberallgaeu; 🇩🇪 Kempten, Germany

Universtity Medical Center Groningen; 🇳🇱 Groningen, The Netherlands, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Royal Brompton; 🇬🇧 London, United Kingdom