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Targeted Lung Denervation for Patients With Moderate to Severe COPD (AIRFLOW)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Holaira™ Lung Denervation System with energy delivery
Holaira™ Lung Denervation System without energy delivery
Sponsored by
Nuvaira, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Targeted Lung Denervation, Intervention, Lung Function, Safety, Device

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • AKH Allgemeines Krankenhaus der Stadt Linz GmbH
  • Otto-Wagner-Spital
  • CHU Saint Pierre
  • University Hospital Leuven
  • CHU de Grenoble
  • CHU de Lille
  • CHU de Paris - Hopital Bichat Claude Bernard
  • CHU de Reims
  • CHU de Strasbourg
  • Charite-Universitatsmedizin Berlin
  • Universitatklinikum Bonn
  • Ruhrlandklinik - West German Lung Center
  • Asklepios-Fachkliniken
  • Thoraxklinik Heidelberg
  • Klinikverbund Kempten-Oberallgaeu
  • Universtity Medical Center Groningen
  • Academic Medical Center
  • Royal Brompton

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Targeted Lung Denervation

Sham-Control

Arm Description

active targeted lung denervation

non-active targeted lung denervation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse events over 3 years
The assessment of safety will be based on reporting of adverse events, particularly those adverse events that are respiratory in origin.
Device Success
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
Measures include: FEV1, FVC, FEV1/FVC
Change in Functional testing: Cycle Ergometry & 6MWT
Heath-related Quality of Life (SGRQ-C & EQ-5D)
Procedure Success
Procedure Success is defined as device success without the report of an adverse event through hospital discharge.
Plethysmography measures
Measures include Raw, TLC, IC, ITGW
CT Scan assessment

Full Information

First Posted
February 5, 2014
Last Updated
April 11, 2022
Sponsor
Nuvaira, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02058459
Brief Title
Targeted Lung Denervation for Patients With Moderate to Severe COPD
Acronym
AIRFLOW
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 4, 2014 (Actual)
Primary Completion Date
January 26, 2018 (Actual)
Study Completion Date
June 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nuvaira, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Targeted Lung Denervation, Intervention, Lung Function, Safety, Device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Targeted Lung Denervation
Arm Type
Active Comparator
Arm Description
active targeted lung denervation
Arm Title
Sham-Control
Arm Type
Sham Comparator
Arm Description
non-active targeted lung denervation
Intervention Type
Device
Intervention Name(s)
Holaira™ Lung Denervation System with energy delivery
Intervention Type
Device
Intervention Name(s)
Holaira™ Lung Denervation System without energy delivery
Primary Outcome Measure Information:
Title
AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 6.5 months
Description
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.
Time Frame
3-6.5 months
Secondary Outcome Measure Information:
Title
Adverse events over 3 years
Description
The assessment of safety will be based on reporting of adverse events, particularly those adverse events that are respiratory in origin.
Time Frame
3 years
Title
Device Success
Description
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.
Time Frame
6 months
Title
Spirometry measures
Description
Measures include: FEV1, FVC, FEV1/FVC
Time Frame
3 years
Title
Change in Functional testing: Cycle Ergometry & 6MWT
Time Frame
3 years
Title
Heath-related Quality of Life (SGRQ-C & EQ-5D)
Time Frame
3 years
Title
Procedure Success
Description
Procedure Success is defined as device success without the report of an adverse event through hospital discharge.
Time Frame
Through discharge
Title
Plethysmography measures
Description
Measures include Raw, TLC, IC, ITGW
Time Frame
3 years
Title
CT Scan assessment
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk-Jan Slebos, MD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arschang Valipour, MD
Organizational Affiliation
Otto-Wagner-Spital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AKH Allgemeines Krankenhaus der Stadt Linz GmbH
City
Linz
Country
Austria
Facility Name
Otto-Wagner-Spital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
CHU Saint Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38700
Country
France
Facility Name
CHU de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CHU de Paris - Hopital Bichat Claude Bernard
City
Paris
Country
France
Facility Name
CHU de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Charite-Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitatklinikum Bonn
City
Bonn
Country
Germany
Facility Name
Ruhrlandklinik - West German Lung Center
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Asklepios-Fachkliniken
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Thoraxklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69126
Country
Germany
Facility Name
Klinikverbund Kempten-Oberallgaeu
City
Kempten
ZIP/Postal Code
87509
Country
Germany
Facility Name
Universtity Medical Center Groningen
City
Groningen
State/Province
The Netherlands
ZIP/Postal Code
9700
Country
Netherlands
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Royal Brompton
City
London
ZIP/Postal Code
SW3,6NY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33177818
Citation
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.
Results Reference
derived
PubMed Identifier
31404499
Citation
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.
Results Reference
derived

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Targeted Lung Denervation for Patients With Moderate to Severe COPD

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