Two-Year Outcomes for the Double-Blind, Randomized, Sham-Controlled Study of Targeted Lung Denervation in Patients with Moderate to Severe COPD: AIRFLOW-2.
COPD
COPD exacerbation
bronchoscopy
targeted lung denervation
Journal
International journal of chronic obstructive pulmonary disease
ISSN: 1178-2005
Titre abrégé: Int J Chron Obstruct Pulmon Dis
Pays: New Zealand
ID NLM: 101273481
Informations de publication
Date de publication:
2020
2020
Historique:
received:
12
06
2020
accepted:
07
10
2020
entrez:
12
11
2020
pubmed:
13
11
2020
medline:
29
6
2021
Statut:
epublish
Résumé
COPD exacerbations are associated with worsening clinical outcomes and increased healthcare costs, despite use of optimal medical therapy. A novel bronchoscopic therapy, targeted lung denervation (TLD), which disrupts parasympathetic pulmonary innervation of the lung, has been developed to reduce clinical consequences of cholinergic hyperactivity and its impact on COPD exacerbations. The AIRFLOW-2 study assessed the durability of safety and efficacy of TLD additive to optimal drug therapy compared to sham bronchoscopy and optimal drug therapy alone in subjects with moderate-to-severe, symptomatic COPD two years post randomization. TLD was performed in COPD patients (FEV Eighty-two subjects (FEV In a randomized trial, TLD demonstrated a durable effect of significantly lower risk of severe AECOPD over 2 years. Further, lung function and quality of life remained stable following TLD. NCT02058459.
Identifiants
pubmed: 33177818
doi: 10.2147/COPD.S267409
pii: 267409
pmc: PMC7652218
doi:
Banques de données
ClinicalTrials.gov
['NCT02058459']
Types de publication
Case Reports
Clinical Trial
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
2807-2816Informations de copyright
© 2020 Valipour et al.
Déclaration de conflit d'intérêts
DJS reports grant, consultancy fees paid to the institution, and nonfinancial support from Nuvaira, Inc. during the conduct of the study. HSN reports employment with Nuvaira, Inc. MM reports consultancy fees and employment with Nuvaira, Inc. during the conduct of the study. MM owns stock from Nuvaira, Inc in exchange for multiple patents with Nuvaira. AV reports speaker fees from Nuvaira during the conduct of the study. PLS reports personal fees from Nuvaira during the conduct of the study; personal fees for consultancy from Olympus, PneumRX/BTG, Creo Medical, and from CSA medical outside the submitted work. FJH reports personal fees for serving at the advisory board for Olympus, Pumonx, and Uptake outside the submitted work. Christophe Pison reports grants, personal fees, non-financial support, and fees to CHUGA to conduct RCT IPSII, AF2 and AF3 from Nuvaira during the conduct of the study; grants, personal fees, non-financial support in the field of COPD and Asthma from GSK France, Boehringer Ingelheim, Chiesi, and AstraZeneca outside the submitted work. PIB reports non-financial support from Nuvaira during the conduct of the study. RK reports grants, personal fees from Nuvaira during the conduct of the study. WG reports personal fees as speaker and receives travel supports from PulmonX and Astra Zeneca, and travel support from PneumRX outside the submitted work. TP reports costs of clinical trial from Holaira-Nuvaira during the conduct of the study; personal fees served in the COPD advisory board from Novartis, Chiesi, and Boehringer Ingelheim, grants for clinical research from Astra Zeneca outside the submitted work. GD reports personal fees from Nuvaira during the conduct of the study; personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, BTG-PneumRx, and Novartis outside the submitted work. RG was scientific advisory board member for Nuvaira until 2019; reports grants from Boehringer Ingelheim, Aquilo, Novartis, and Chiesi outside the submitted work. The authors report no other conflicts of interest in this work.
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