Targeted Lung Denervation for Patients With Moderate to Severe COPD

NCT ID: NCT02058459

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-04
• Study Completion Date: 2020-06-16

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Targeted Lung Denervation

active targeted lung denervation

Group Type: ACTIVE_COMPARATOR

Holaira™ Lung Denervation System with energy delivery

Intervention Type: DEVICE

Sham-Control

non-active targeted lung denervation

Group Type: SHAM_COMPARATOR

Holaira™ Lung Denervation System without energy delivery

Intervention Type: DEVICE

Interventions

Holaira™ Lung Denervation System with energy delivery

Intervention Type: DEVICE

Holaira™ Lung Denervation System without energy delivery

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nuvaira, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirk-Jan Slebos, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Arschang Valipour, MD

Role: PRINCIPAL_INVESTIGATOR

Otto-Wagner-Spital

Locations

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

Universitatklinikum Bonn

Bonn, , Germany

Ruhrlandklinik - West German Lung Center

Essen, , Germany

Asklepios-Fachkliniken

Gauting, , 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

Countries

Austria; Belgium; France; Germany; Netherlands; United Kingdom

References

Valipour A, Shah PL, Herth FJ, Pison C, Schumann C, Hubner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Conway F, Duller M, Mayse M, Norman HS, Slebos DJ; AIRFLOW-2 Trial Study Group. Two-Year Outcomes for the Double-Blind, Randomized, Sham-Controlled Study of Targeted Lung Denervation in Patients with Moderate to Severe COPD: AIRFLOW-2. Int J Chron Obstruct Pulmon Dis. 2020 Nov 5;15:2807-2816. doi: 10.2147/COPD.S267409. eCollection 2020.

Reference Type: DERIVED

PMID: 33177818 (View on PubMed)

Slebos DJ, Shah PL, Herth FJF, Pison C, Schumann C, Hubner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Srikanthan K, Duller M, Valipour A; AIRFLOW-2 Study Group. Safety and Adverse Events after Targeted Lung Denervation for Symptomatic Moderate to Severe Chronic Obstructive Pulmonary Disease (AIRFLOW). A Multicenter Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Dec 15;200(12):1477-1486. doi: 10.1164/rccm.201903-0624OC.

Reference Type: DERIVED

PMID: 31404499 (View on PubMed)

Other Identifiers

AIRFLOW

Identifier Type: -

Identifier Source: org_study_id