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

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ClinicalTrials.gov Identifier: NCT02058459
Recruitment Status : Active, not recruiting
First Posted : February 10, 2014
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Device: Holaira™ Lung Denervation System with energy delivery Device: Holaira™ Lung Denervation System without energy delivery Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Active Comparator: Targeted Lung Denervation
active targeted lung denervation
Device: Holaira™ Lung Denervation System with energy delivery
Sham Comparator: Sham-Control
non-active targeted lung denervation
Device: Holaira™ Lung Denervation System without energy delivery



Primary Outcome Measures :
  1. AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 6.5 months [ Time Frame: 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 :
  1. Adverse events over 3 years [ Time Frame: 3 years ]
    The assessment of safety will be based on reporting of adverse events, particularly those adverse events that are respiratory in origin.

  2. Device Success [ Time Frame: 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.

  3. Spirometry measures [ Time Frame: 3 years ]
    Measures include: FEV1, FVC, FEV1/FVC

  4. Change in Functional testing: Cycle Ergometry & 6MWT [ Time Frame: 3 years ]
  5. Heath-related Quality of Life (SGRQ-C & EQ-5D) [ Time Frame: 3 years ]
  6. Procedure Success [ Time Frame: Through discharge ]
    Procedure Success is defined as device success without the report of an adverse event through hospital discharge.

  7. Plethysmography measures [ Time Frame: 3 years ]
    Measures include Raw, TLC, IC, ITGW

  8. CT Scan assessment [ Time Frame: 3 years ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058459


Locations
Austria
AKH Allgemeines Krankenhaus der Stadt Linz GmbH
Linz, Austria
Otto-Wagner-Spital
Vienna, Austria, 1140
Belgium
CHU Saint Pierre
Brussels, Belgium, 1000
University Hospital Leuven
Leuven, Belgium, 3000
France
CHU de Grenoble
Grenoble, France, 38700
CHU de Lille
Lille, France, 59000
CHU de Paris - Hopital Bichat Claude Bernard
Paris, France
CHU de Reims
Reims, France, 51092
CHU de Strasbourg
Strasbourg, France, 67000
Germany
Charite-Universitatsmedizin Berlin
Berlin, Germany, 13353
Universitatklinikum Bonn
Bonn, Germany
Ruhrlandklinik - West German Lung Center
Essen, Germany, 45239
Asklepios-Fachkliniken
Gauting, Germany, 82131
Thoraxklinik Heidelberg
Heidelberg, Germany, D-69126
Klinikverbund Kempten-Oberallgaeu
Kempten, Germany, 87509
Netherlands
Universtity Medical Center Groningen
Groningen, The Netherlands, Netherlands, 9700
Academic Medical Center
Amsterdam, Netherlands
United Kingdom
Royal Brompton
London, United Kingdom, SW3,6NY
Sponsors and Collaborators
Nuvaira, Inc.
Investigators
Principal Investigator: Dirk-Jan Slebos, MD University Medical Center Groningen
Principal Investigator: Arschang Valipour, MD Otto-Wagner-Spital

Responsible Party: Nuvaira, Inc.
ClinicalTrials.gov Identifier: NCT02058459     History of Changes
Other Study ID Numbers: AIRFLOW
First Posted: February 10, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: February 2017

Keywords provided by Nuvaira, Inc.:
Chronic obstructive pulmonary disease, targeted lung denervation, intervention, device, safety, lung function, Holaira

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases