Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
COPD, Targeted Lung Denervation, Intervention, Lung Function, Safety, Device
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.
Interventions
DEVICEHolaira™ Lung Denervation System with energy delivery
DEVICEHolaira™ Lung Denervation System without energy delivery
Sponsors
Nuvaira, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 6.5 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Device Success | 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 | 3 years | Measures include: FEV1, FVC, FEV1/FVC |
| Change in Functional testing: Cycle Ergometry & 6MWT | 3 years | — |
| Adverse events over 3 years | 3 years | The assessment of safety will be based on reporting of adverse events, particularly those adverse events that are respiratory in origin. |
| Procedure Success | Through discharge | Procedure Success is defined as device success without the report of an adverse event through hospital discharge. |
| Plethysmography measures | 3 years | Measures include Raw, TLC, IC, ITGW |
| CT Scan assessment | 3 years | — |
| Heath-related Quality of Life (SGRQ-C & EQ-5D) | 3 years | — |
Countries
Austria, Belgium, France, Germany, Netherlands, United Kingdom
Outcome results
None listed