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Trial record 1 of 3 for:    Holaira
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Targeted Lung Denervation for Patients With Moderate to Severe COPD (AIRFLOW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02058459
Recruitment Status : Completed
First Posted : February 10, 2014
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
Nuvaira, Inc.

Tracking Information
First Submitted Date  ICMJE February 5, 2014
First Posted Date  ICMJE February 10, 2014
Last Update Posted Date April 13, 2022
Actual Study Start Date  ICMJE August 4, 2014
Actual Primary Completion Date January 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
Rate of Respiratory Adverse Events [ Time Frame: 6 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
  • 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.
  • 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.
  • Spirometry measures [ Time Frame: 3 years ]
    Measures include: FEV1, FVC, FEV1/FVC
  • Change in Functional testing: Cycle Ergometry & 6MWT [ Time Frame: 3 years ]
  • Heath-related Quality of Life (SGRQ-C & EQ-5D) [ Time Frame: 3 years ]
  • Procedure Success [ Time Frame: Through discharge ]
    Procedure Success is defined as device success without the report of an adverse event through hospital discharge.
  • Plethysmography measures [ Time Frame: 3 years ]
    Measures include Raw, TLC, IC, ITGW
  • CT Scan assessment [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
  • 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.
  • 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.
  • Spirometry measures [ Time Frame: 3 years ]
    Measures include: FEV1, FVC, FEV1/FVC
  • Change in Functional testing: Cycle Ergometery & 6MWT [ Time Frame: 3 years ]
  • Heath-related Quality of Life (SGRQ-C & EQ-5D) [ Time Frame: 3 years ]
  • Procedure Success [ Time Frame: 6 months ]
    Procedure Success is defined as device success without the report of an adverse event through hospital discharge.
  • Plethysmography measures [ Time Frame: 3 years ]
    Measures include Raw, TLC, IC, ITGW
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Targeted Lung Denervation for Patients With Moderate to Severe COPD
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Device: Holaira™ Lung Denervation System with energy delivery
  • Device: Holaira™ Lung Denervation System without energy delivery
Study Arms  ICMJE
  • Active Comparator: Targeted Lung Denervation
    active targeted lung denervation
    Intervention: Device: Holaira™ Lung Denervation System with energy delivery
  • Sham Comparator: Sham-Control
    non-active targeted lung denervation
    Intervention: Device: Holaira™ Lung Denervation System without energy delivery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2022)
128
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2014)
170
Actual Study Completion Date  ICMJE June 16, 2020
Actual Primary Completion Date January 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Netherlands,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02058459
Other Study ID Numbers  ICMJE AIRFLOW
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Nuvaira, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Nuvaira, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dirk-Jan Slebos, MD University Medical Center Groningen
Principal Investigator: Arschang Valipour, MD Otto-Wagner-Spital
PRS Account Nuvaira, Inc.
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP