Clinical trial NCT02058459: Targeted Lung Denervation for Patients With Moderate to Severe COPD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Targeted Lung Denervation
Intervention
Lung Function
Safety
Device
Lead sponsor: Nuvaira, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-10
Enrollment: 128
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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;

Primary outcomes:
measure: AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 6.5 months
timeFrame: 3-6.5 months
Secondary outcomes:
measure: Adverse events over 3 years
timeFrame: 3 years
measure: Device Success
timeFrame: 6 months
measure: Spirometry measures
timeFrame: 3 years
measure: Change in Functional testing: Cycle Ergometry & 6MWT
timeFrame: 3 years
measure: Heath-related Quality of Life (SGRQ-C & EQ-5D)
timeFrame: 3 years
measure: Procedure Success
timeFrame: Through discharge
measure: Plethysmography measures
timeFrame: 3 years
measure: CT Scan assessment
timeFrame: 3 years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: AKH Allgemeines Krankenhaus der Stadt Linz GmbH
city: Vienna
country: Austria
facility: Otto-Wagner-Spital
city: Brussels
country: Belgium
facility: CHU Saint Pierre
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: CHU de Lille
city: Paris
country: France
facility: CHU de Paris - Hopital Bichat Claude Bernard
city: Reims
country: France
facility: CHU de Reims
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Berlin
country: Germany
facility: Charite-Universitatsmedizin Berlin
city: Bonn
country: Germany
facility: Universitatklinikum Bonn
city: Essen
country: Germany
facility: Ruhrlandklinik - West German Lung Center
city: Gauting
country: Germany
facility: Asklepios-Fachkliniken
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Kempten
country: Germany
facility: Klinikverbund Kempten-Oberallgaeu
city: Groningen
country: Netherlands
facility: Universtity Medical Center Groningen
state: The Netherlands
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: London
country: United Kingdom
facility: Royal Brompton
Study officials:
affiliation: University Medical Center Groningen
name: Dirk-Jan Slebos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Otto-Wagner-Spital
name: Arschang Valipour, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.