A multicenter, prospective, single-arm clinical investigation of a modified staged treatment algorithm using the AeriSeal system - The STAGE trial.

Abstract

INTRODUCTION:

Treatment with AeriSeal is an alternate treatment option to achieve lung volume reduction in patients with severe COPD and emphysema who are not eligible for valve treatment. This study aimed to assess the safety and mode of action of a modified staged treatment algorithm with a staged treatment with lower dose of AeriSeal.

METHODS:

We performed a prospective, multicenter feasibility study. AeriSeal was administered during two sequential bronchoscopies: 2 subsegments of a lobe treated with two 5 mL doses, followed by two 10 mL doses in a contralateral lobe after 6 weeks.

RESULTS:

A total of 14 patients (36% male, mean FEV1 28.4% ± 6.7% of predicted) were enrolled. Ten patients completed both treatments, four were treated unilaterally. AeriSeal treatment resulted in significant TLVR (median 220.5 mL) at 3 months follow up. There were no significant changes from baseline at 12 months in lung function, exercise capacity and quality of life. During the 3-month post-treatment period, respiratory SAEs included 5 COPD exacerbations in 4 (28.6%) subjects, post-treatment acute inflammatory response (PAIR) in 2 (14.3%) subjects, and 1 respiratory failure event in 1 (7.1%) subject.

CONCLUSION:

The staged and lower dosed administration of AeriSeal does not impact the overall safety profile in terms of reducing the type and frequency of respiratory SAEs previously reported for a single-stage treatment. A larger volume of AeriSeal than used in this study may be necessary to provide meaningful clinical benefits.

• Authors: T David Koster, Ralf Eberhardt, Ralf-Harto Huebner, Arschang Valipour, Felix Herth, Karin Klooster, Narinder S Shargill, Sri Radhakrishnan, Dirk-Jan Slebos
• Journal: Respiratory medicine (Respir Med) Vol. 203 Pg. 106989 (11 2022) ISSN: 1532-3064 [Electronic] England
• PMID: 36166995 (Publication Type: Multicenter Study, Journal Article)
• Copyright: Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Chemical References

• AeriSeal

Topics

• Humans
• Male
• Female
• Quality of Life
• Prospective Studies
• Treatment Outcome
• Pulmonary Emphysema
• Bronchoscopy (methods)
• Pneumonectomy (methods)
• Pulmonary Disease, Chronic Obstructive (drug therapy, etiology)
• Algorithms
• Forced Expiratory Volume (physiology)