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Randomized, single blind, controlled trial of inhaled glutathione vs placebo in patients with cystic fibrosis

2014; Elsevier BV; Volume: 14; Issue: 2 Linguagem: Inglês

10.1016/j.jcf.2014.09.014

1873-5010

Cecilia Calabrese, Antonella Tosco, Pasquale Abete, Vincenzo Carnovale, Christian Basile, A. Magliocca, Serena Quattrucci, Stefania De Sanctis, F. Alatri, Gennaro Mazzarella, L. De Pietro, Carlos del Risco Turiño, Enrico Melillo, Paolo Buonpensiero, A. Di Pasqua, Valeria Raia,

Inhalation and Respiratory Drug Delivery

BackgroundIn cystic fibrosis (CF) the defective CF transmembrane conductance regulator protein may be responsible for the impaired transport of glutathione (GSH), the first line defense of the lung against oxidative stress. The aim of this single-blind, randomized, placebo-controlled trial was to evaluate the effect of inhaled GSH in patients with CF.Methods54 adult and 51 pediatric patients were randomized to receive inhaled GSH or placebo twice daily for 12 months.ResultsTwelve month treatment with inhaled GSH did not achieve our predetermined primary outcome measure of 15% improvement in FEV1%. Only in patients with moderate lung disease, 3, 6 and 9 months therapy with GSH resulted in a statistically significant increase of FEV1 values from the baseline. Moreover GSH therapy improved 6-minute walking test in pediatric population. GSH was well tolerated by all patients.ConclusionsInhaled GSH has slight positive effects in CF patients with moderate lung disease warranting further study.Trial registryClinicalTrials.gov; No.: NCT01450267; URL: www.clinicaltrialsgov.