en
Scientific article
English

Nebulised liposomal amphotericin-B as maintenance therapy in allergic bronchopulmonary aspergillosis: a randomised, multicentre trial

Published inEuropean respiratory journal, vol. 59, no. 6, 2102218
Publication date2022-06
First online date2022-06-16
Abstract

Background: In allergic bronchopulmonary aspergillosis (ABPA), prolonged nebulised antifungal treatment may be a strategy for maintaining remission.

Methods: We performed a randomised, single-blind, clinical trial in 30 centres. Patients with controlled ABPA after 4-month attack treatment (corticosteroids and itraconazole) were randomly assigned to nebulised liposomal amphotericin-B or placebo for 6 months. The primary outcome was occurrence of a first severe clinical exacerbation within 24 months following randomisation. Secondary outcomes included the median time to first severe clinical exacerbation, number of severe clinical exacerbations per patient, ABPA-related biological parameters.

Results: Among 174 enrolled patients with ABPA from March 2015 through July 2017, 139 were controlled after 4-month attack treatment and were randomised. The primary outcome occurred in 33 (50.8%) out of 65 patients in the nebulised liposomal amphotericin-B group and 38 (51.3%) out of 74 in the placebo group (absolute difference -0.6%, 95% CI -16.8- +15.6%; OR 0.98, 95% CI 0.50-1.90; p=0.95). The median (interquartile range) time to first severe clinical exacerbation was longer in the liposomal amphotericin-B group: 337 days (168-476 days) versus 177 days (64-288 days). At the end of maintenance therapy, total immunoglobulin-E and Aspergillus precipitins were significantly decreased in the nebulised liposomal amphotericin-B group.

Conclusions: In ABPA, maintenance therapy using nebulised liposomal amphotericin-B did not reduce the risk of severe clinical exacerbation. The presence of some positive secondary outcomes creates clinical equipoise for further research.

Trial registration: ClinicalTrials.gov NCT02273661.

eng
Keywords
  • Amphotericin B / adverse effects
  • Antifungal Agents / therapeutic use
  • Aspergillosis, Allergic Bronchopulmonary / drug therapy
  • Aspergillus
  • Humans
  • Single-Blind Method
Affiliation Not a UNIGE publication
Citation (ISO format)
GODET, Cendrine et al. Nebulised liposomal amphotericin-B as maintenance therapy in allergic bronchopulmonary aspergillosis: a randomised, multicentre trial. In: European respiratory journal, 2022, vol. 59, n° 6, p. 2102218. doi: 10.1183/13993003.02218-2021
Main files (1)
Article (Published version)
accessLevelRestricted
Secondary files (2)
Identifiers
ISSN of the journal0903-1936
26views
0downloads

Technical informations

Creation03/13/2023 8:21:52 AM
First validation05/25/2023 5:13:14 AM
Update time05/25/2023 5:13:14 AM
Status update05/25/2023 5:13:14 AM
Last indexation05/06/2024 3:58:04 PM
All rights reserved by Archive ouverte UNIGE and the University of GenevaunigeBlack