Trial record 1 of 3 for:
Holaira
Targeted Lung Denervation for Patients With Moderate to Severe COPD (AIRFLOW)
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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 |
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Recruitment Status :
Completed
First Posted : February 10, 2014
Last Update Posted : April 13, 2022
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Sponsor:
Nuvaira, Inc.
Information provided by (Responsible Party):
Nuvaira, Inc.
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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 | Not Applicable |
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) |
| Actual Enrollment : | 128 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. |
| Actual Study Start Date : | August 4, 2014 |
| Actual Primary Completion Date : | January 26, 2018 |
| Actual Study Completion Date : | June 16, 2020 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Targeted Lung Denervation
active targeted lung denervation
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Device: Holaira™ Lung Denervation System with energy delivery |
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Sham Comparator: Sham-Control
non-active targeted lung denervation
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Device: Holaira™ Lung Denervation System without energy delivery |
Primary Outcome Measures :
- 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 :
- 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 ]
Information from the National Library of Medicine
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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
Show 18 study locations
Sponsors and Collaborators
Nuvaira, Inc.
Investigators
| Principal Investigator: | Dirk-Jan Slebos, MD | University Medical Center Groningen | |
| Principal Investigator: | Arschang Valipour, MD | Otto-Wagner-Spital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nuvaira, Inc. |
| ClinicalTrials.gov Identifier: | NCT02058459 |
| Other Study ID Numbers: |
AIRFLOW |
| First Posted: | February 10, 2014 Key Record Dates |
| Last Update Posted: | April 13, 2022 |
| Last Verified: | April 2022 |
Keywords provided by Nuvaira, Inc.:
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COPD Targeted Lung Denervation Intervention |
Lung Function Safety Device |
Additional relevant MeSH terms:
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Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases |