Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira® lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3)

Autor: Dirk-Jan Slebos, Bruno Degano, Arschang Valipour, Pallav L. Shah, Gaetan Deslée, Frank C. Sciurba, on behalf of the AIRFLOW-3 Trial Study Group
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: BMC Pulmonary Medicine, Vol 20, Iss 1, Pp 1-10 (2020)
Druh dokumentu: article
ISSN: 1471-2466
DOI: 10.1186/s12890-020-1058-5
Popis: 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
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