Nebulised liposomal-amphotericin-B as maintenance therapy in allergic bronchopulmonary aspergillosis : a randomised, multicentre trial - CNRS - Centre national de la recherche scientifique Accéder directement au contenu
Article Dans Une Revue European Respiratory Journal Année : 2022

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

1 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
2 UBO - Université de Brest
3 DMIP - Brest - Département de Médecine Interne et Pneumologie [Brest]
4 CHRU Tours - Centre Hospitalier Régional Universitaire de Tours
5 UT - Université de Tours
6 CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
7 UGA - Université Grenoble Alpes
8 CHU Angers - Centre Hospitalier Universitaire d'Angers
9 Hôpital Haut-Lévêque [CHU Bordeaux]
10 PHERE (UMR_S_1152 / U1152) - Physiopathologie et Epidémiologie des Maladies Respiratoires
11 Centre Hospitalier René Dubos [Pontoise]
12 HUS - Les Hôpitaux Universitaires de Strasbourg
13 CHU Amiens-Picardie
14 AGIR - Agents infectieux, résistance et chimiothérapie - UR UPJV 4294
15 PhyMedExp - Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046]
16 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
17 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
18 CIIL - Centre d’Infection et d’Immunité de Lille - INSERM U 1019 - UMR 9017 - UMR 8204
19 CHU Rouen
20 CHIC - Centre Hospitalier Intercommunal de Créteil
21 Service de pneumologie [Toulouse]
22 Hôpital d'instruction des Armées Percy
23 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
24 Pôle des Cardiopathies Congénitales du Nouveau-Né à L'adulte - Centre Constitutif Cardiopathies Congénitales Complexes M3C, Groupe Hospitalier Paris Saint-Joseph, Hôpital Marie-Lannelongue, Inserm U999, Université Paris-Saclay
25 UCA - Université Clermont Auvergne
26 Service de Pneumologie [CHU Clermont-Ferrand]
27 CHU Nantes - Centre Hospitalier Universitaire de Nantes
28 Centre Hospitalier Le Mans (CH Le Mans)
29 AP-HP - Hopital Saint-Louis [AP-HP]
30 Service de Pneumologie, oncologie thoracique et allergologie respiratoire [CHRU Besançon]
31 CIC 1402 - CIC Poitiers – Centre d'investigation clinique de Poitiers
32 Hôpital Foch [Suresnes]
33 CRCTB - Centre de recherche Cardio-Thoracique de Bordeaux [Bordeaux]
34 CHU Tenon [AP-HP]
Stéphane Dominique
  • Fonction : Auteur
Jacques Cadranel

Résumé

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 a 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%) of 65 patients in nebulised liposomal-amphotericin-B group and 38 (51.3%) of 74 in placebo group (absolute difference −0.6%, 95% CI −16.8% to +15.6%, odds ratio 0.98, 95% CI 0.50 to 1.90; p=0.95). The median time-to-first severe clinical exacerbation was longer in liposomal-amphotericin-B group, 337 days (IQR, 168 to 476) versus 177 (64 to 288). At the end of maintenance therapy, total immunoglobulin-E and Aspergillus precipitins were significantly decreased in 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.
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hal-03427245 , version 1 (07-11-2022)

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Cendrine Godet, Francis Couturaud, Sylvain Marchand-Adam, Christophe Pison, Frédéric Gagnadoux, et al.. Nebulised liposomal-amphotericin-B as maintenance therapy in allergic bronchopulmonary aspergillosis : a randomised, multicentre trial. European Respiratory Journal, 2022, 59 (6), pp.2102218. ⟨10.1183/13993003.02218-2021⟩. ⟨hal-03427245⟩
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