Nebulised liposomal amphotericin-B as maintenance therapy in allergic bronchopulmonary aspergillosis: a randomised, multicentre trial.
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Godet Cendrine, Couturaud Francis, Marchand-Adam Sylvain, Pison Christophe, Gagnadoux Frédéric, Blanchard Elodie, Taillé Camille, Philippe Bruno, Hirschi Sandrine, Andréjak Claire, Bourdin Arnaud, Chenivesse Cécile, Dominique Stéphane, Bassinet Laurence, Murris-Espin Marlène, Rivière Frédéric, Garcia Gilles, Caillaud Denis, Blanc François-Xavier, Goupil François, Bergeron Anne, Gondouin Anne, Frat Jean-Pierre, Flament Thomas, Camara Boubou, Priou Pascaline, Brun Anne-Laure, Laurent François, Ragot Stéphanie, Cadranel Jacques, NebuLamB study group and GREPI network, Godet C, Couturaud F, Cadranel J, Frat J-P, Brun A-L, Laurent F, Marchand-Adam S, Pison C, Gagnadoux F, Blanchard E, Taillé C, Philippe B, Hirschi S, Andréjak C, Chenivesse C, Dominique S, Bassinet L, Murris-Espin M, Rivière F, Garcia G, Caillaud D, Blanc F-X, Goupil F, Gondouin A, Flament T, Camara B, Priou P, Ragot S
Аннотация
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.