NCT02058459

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
6 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

August 4, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2018

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2020

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

3.5 years

First QC Date

February 5, 2014

Last Update Submit

April 11, 2022

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDTargeted Lung DenervationInterventionLung FunctionSafetyDevice

Outcome Measures

Primary Outcomes (1)

  • AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 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.

    3-6.5 months

Secondary Outcomes (8)

  • Adverse events over 3 years

    3 years

  • Device Success

    6 months

  • Spirometry measures

    3 years

  • Change in Functional testing: Cycle Ergometry & 6MWT

    3 years

  • Heath-related Quality of Life (SGRQ-C & EQ-5D)

    3 years

  • +3 more secondary outcomes

Study Arms (2)

Targeted Lung Denervation

ACTIVE COMPARATOR

active targeted lung denervation

Device: Holaira™ Lung Denervation System with energy delivery

Sham-Control

SHAM COMPARATOR

non-active targeted lung denervation

Device: Holaira™ Lung Denervation System without energy delivery

Interventions

Holaira™ Lung Denervation System with energy deliveryDEVICE
Targeted Lung Denervation
Holaira™ Lung Denervation System without energy deliveryDEVICE
Sham-Control

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

AKH Allgemeines Krankenhaus der Stadt Linz GmbH

Linz, Austria

Location

Otto-Wagner-Spital

Vienna, 1140, Austria

Location

CHU Saint Pierre

Brussels, 1000, Belgium

Location

University Hospital Leuven

Leuven, 3000, Belgium

Location

CHU de Grenoble

Grenoble, 38700, France

Location

CHU de Lille

Lille, 59000, France

Location

CHU de Paris - Hopital Bichat Claude Bernard

Paris, France

Location

CHU de Reims

Reims, 51092, France

Location

CHU de Strasbourg

Strasbourg, 67000, France

Location

Charite-Universitatsmedizin Berlin

Berlin, 13353, Germany

Location

Universitatklinikum Bonn

Bonn, Germany

Location

Ruhrlandklinik - West German Lung Center

Essen, 45239, Germany

Location

Asklepios-Fachkliniken

Gauting, 82131, Germany

Location

Thoraxklinik Heidelberg

Heidelberg, D-69126, Germany

Location

Klinikverbund Kempten-Oberallgaeu

Kempten, 87509, Germany

Location

Universtity Medical Center Groningen

Groningen, The Netherlands, 9700, Netherlands

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Royal Brompton

London, SW3,6NY, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 33177818DERIVED

  • 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.

    PMID: 31404499DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dirk-Jan Slebos, MD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

  • Arschang Valipour, MD

    Otto-Wagner-Spital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 10, 2014

Study Start

August 4, 2014

Primary Completion

January 26, 2018

Study Completion

June 16, 2020

Last Updated

April 13, 2022

Record last verified: 2022-04

Locations

NL(2)DE(6)AU(2)GB(1)FR(5)BE(2)