Targeted Lung Denervation for Patients With Moderate to Severe COPD

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— AIRFLOW  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058459
• Other study ID #: AIRFLOW
• Status: Completed
• Phase: N/A
• Start date: August 4, 2014
• Est. completion date: June 16, 2020

Study information

• Verified date: April 2022
• Source: Nuvaira, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 16, 2020
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Holaira™ Lung Denervation System with energy delivery

• Holaira™ Lung Denervation System without energy delivery

Locations

Country	Name	City	State
Austria	AKH Allgemeines Krankenhaus der Stadt Linz GmbH	Linz
Austria	Otto-Wagner-Spital	Vienna
Belgium	CHU Saint Pierre	Brussels
Belgium	University Hospital Leuven	Leuven
France	CHU de Grenoble	Grenoble
France	CHU de Lille	Lille
France	CHU de Paris - Hopital Bichat Claude Bernard	Paris
France	CHU de Reims	Reims
France	CHU de Strasbourg	Strasbourg
Germany	Charite-Universitatsmedizin Berlin	Berlin
Germany	Universitatklinikum Bonn	Bonn
Germany	Ruhrlandklinik - West German Lung Center	Essen
Germany	Asklepios-Fachkliniken	Gauting
Germany	Thoraxklinik Heidelberg	Heidelberg
Germany	Klinikverbund Kempten-Oberallgaeu	Kempten
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Universtity Medical Center Groningen	Groningen	The Netherlands
United Kingdom	Royal Brompton	London

Sponsors (1)

Lead Sponsor	Collaborator
Nuvaira, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	6 months
Secondary	Spirometry measures	Measures include: FEV1, FVC, FEV1/FVC	3 years
Secondary	Change in Functional testing: Cycle Ergometry & 6MWT		3 years
Secondary	Heath-related Quality of Life (SGRQ-C & EQ-5D)		3 years
Secondary	Procedure Success	Procedure Success is defined as device success without the report of an adverse event through hospital discharge.	Through discharge
Secondary	Plethysmography measures	Measures include Raw, TLC, IC, ITGW	3 years
Secondary	CT Scan assessment		3 years