Jean-Marc Naccache, Stéphane Jouneau, Morgane Didier, Raphaël Borie, Marine Cachanado, Arnaud Bourdin, Martine Reynaud-Gaubert, Philippe Bonniaud, Dominique Israël-Biet, Grégoire Prévot, Sandrine Hirschi, François Lebargy, Sylvain Marchand-Adam, Nathalie Bautin, Julie Traclet, Emmanuel Gomez, Sylvie Leroy, Frédéric Gagnadoux, Frédéric Rivière, Emmanuel Bergot, Anne Gondouin, Elodie Blanchard, Antoine Parrot, François-Xavier Blanc, Alexandre Chabrol, Stéphane Dominique, Aude Gibelin, Abdellatif Tazi, Laurence Berard, Pierre Yves Brillet, Marie-Pierre Debray, Alexandra Rousseau, Mallorie Kerjouan, Olivia Freynet, Marie-Christine Dombret, Anne-Sophie Gamez, Ana Nieves, Guillaume Beltramo, Jean Pastré, Aurélie Le Borgne-Krams, Tristan Dégot, Claire Launois, Laurent Plantier, Lidwine Wémeau-Stervinou, Jacques Cadranel, Cécile Chenivesse, Dominique Valeyre, Bruno Crestani, Vincent Cottin, Tabassome Simon, Hilario Nunes
BACKGROUND: The use of cyclophosphamide in patients with acute exacerbation of idiopathic pulmonary fibrosis (IPF) is unknown. Our study was designed to evaluate the efficacy and safety of four cyclophosphamide pulses in addition to high-dose methylprednisolone in this population. METHODS: In this double-blind, placebo-controlled trial done in 35 departments across 31 hospitals in France, adult patients (≥18 years) with acute exacerbation of IPF and those with suspected acute exacerbation of IPF were randomly assigned in a 1:1 ratio using a web-based system to receive either intravenous pulses of cyclophosphamide (600 mg/m2 ) plus uromitexan as haemorrhagic cystitis prophylaxis (200 mg/m2 ) at the time of cyclophosphamide administration and then again, 4 h later, or placebo at days 0, 15, 30, and 60...
January 2022: Lancet Respiratory Medicine