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Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira (R) lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3)
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Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira.pdf | Published version | 1.2 MB | Adobe PDF | View/Open |
Title: | Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira (R) lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3) |
Authors: | Slebos, D-J Degano, B Valipour, A Shah, PL Deslee, G Sciurba, FC |
Item Type: | Journal Article |
Abstract: | Background Targeted lung denervation (TLD) is a bronchoscopically delivered ablation therapy that selectively interrupts pulmonary parasympathetic nerve signaling. The procedure has the potential to alter airway smooth muscle tone and reactivity, decrease mucous secretion, and reduce airway inflammation and reflex airway hyperresponsiveness. Secondary outcome analysis of a previous randomized, sham-controlled trial showed a reduction in moderate-to-severe exacerbations in patients with COPD after TLD treatment. A pivotal trial, AIRFLOW-3 has been designed to evaluate the safety and efficacy of TLD combined with optimal medical therapy to reduce moderate or severe exacerbations throughout 1 year, compared with optimal medical therapy alone. Methods The study design is a multicenter, randomized, full sham bronchoscopy controlled, double-blind trial that will enroll 400 patients (1:1 randomization). Key inclusion criteria are FEV1/FVC < 0.7, FEV1 30 to 60% of predicted, post-bronchodilator, ≥ 2 moderate or 1 severe COPD exacerbations in the prior year, and COPD assessment test (CAT) ≥ 10. Primary objective will be the comparison of moderate or severe COPD exacerbations through 12 months of TLD therapy with optimal medical therapy versus optimal medical therapy alone. The sham group will be allowed to cross over at 1 year. Patients will be followed for up to 5 years. Discussion The multicenter, randomized, full sham bronchoscopy controlled, double-blind AIRFLOW-3 trial will evaluate the efficacy of TLD to reduce moderate or severe COPD exacerbations beyond optimal medical therapy alone. The target population are patients with COPD, who suffer persistent symptoms and exacerbations despite optimal treatment, defining an unmet medical need requiring novel therapeutic solutions. This trial is registered at clinicaltrials.gov: NCT03639051. |
Issue Date: | 13-Feb-2020 |
Date of Acceptance: | 23-Jan-2020 |
URI: | http://hdl.handle.net/10044/1/78005 |
DOI: | 10.1186/s12890-020-1058-5 |
ISSN: | 1471-2466 |
Publisher: | BioMed Central |
Start Page: | 1 |
End Page: | 10 |
Journal / Book Title: | BMC Pulmonary Medicine |
Volume: | 20 |
Issue: | 1 |
Copyright Statement: | © The Author(s). 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
Keywords: | Science & Technology Life Sciences & Biomedicine Respiratory System COPD Nerves Targeted lung denervation Acetylcholine Anticholinergic Bronchoscopy EXACERBATIONS PREVENTION TIOTROPIUM Acetylcholine Anticholinergic Bronchoscopy COPD Nerves Targeted lung denervation AIRFLOW-3 Trial Study Group Science & Technology Life Sciences & Biomedicine Respiratory System COPD Nerves Targeted lung denervation Acetylcholine Anticholinergic Bronchoscopy EXACERBATIONS PREVENTION TIOTROPIUM 1102 Cardiorespiratory Medicine and Haematology Respiratory System |
Publication Status: | Published |
Article Number: | ARTN 41 |
Online Publication Date: | 2020-02-13 |
Appears in Collections: | National Heart and Lung Institute |