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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Lung Denervation | Active Comparator | active targeted lung denervation |
|
| Sham-Control | Sham Comparator | non-active targeted lung denervation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holairaâ„¢ Lung Denervation System with energy delivery | Device |
| ||
| Holairaâ„¢ Lung Denervation System without energy delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-6.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk-Jan Slebos, MD | University Medical Center Groningen | Principal Investigator |
| Arschang Valipour, MD | Otto-Wagner-Spital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH Allgemeines Krankenhaus der Stadt Linz GmbH | Linz | Austria | ||||
| Otto-Wagner-Spital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33177818 | Derived | 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. | |
| 31404499 |
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| Device |
|
| 6 months |
| Spirometry measures | Measures include: FEV1, FVC, FEV1/FVC | 3 years |
| Change in Functional testing: Cycle Ergometry & 6MWT | 3 years |
| Heath-related Quality of Life (SGRQ-C & EQ-5D) | 3 years |
| Procedure Success | Procedure Success is defined as device success without the report of an adverse event through hospital discharge. | Through discharge |
| Plethysmography measures | Measures include Raw, TLC, IC, ITGW | 3 years |
| CT Scan assessment | 3 years |
| Vienna |
| 1140 |
| Austria |
| CHU Saint Pierre | Brussels | 1000 | Belgium |
| University Hospital Leuven | Leuven | 3000 | Belgium |
| CHU de Grenoble | Grenoble | 38700 | France |
| CHU de Lille | Lille | 59000 | France |
| CHU de Paris - Hopital Bichat Claude Bernard | Paris | France |
| CHU de Reims | Reims | 51092 | France |
| CHU de Strasbourg | Strasbourg | 67000 | France |
| Charite-Universitatsmedizin Berlin | Berlin | 13353 | Germany |
| Universitatklinikum Bonn | Bonn | Germany |
| Ruhrlandklinik - West German Lung Center | Essen | 45239 | Germany |
| Asklepios-Fachkliniken | Gauting | 82131 | Germany |
| Thoraxklinik Heidelberg | Heidelberg | D-69126 | Germany |
| Klinikverbund Kempten-Oberallgaeu | Kempten | 87509 | Germany |
| Universtity Medical Center Groningen | Groningen | The Netherlands | 9700 | Netherlands |
| Academic Medical Center | Amsterdam | Netherlands |
| Royal Brompton | London | SW3,6NY | United Kingdom |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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