A Double-Blind Comparison of RU-41740 (‘Biostim’) and Placebo in Recurrent Upper Respiratory Tract Infections in Children with Cystic Fibrosis
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This study was designed to evaluate the prophylactic action of RU-41740 (‘Biostim’) on upper respiratory tract (URT) infections in a group of children with mild cystic fibrosis. RU-41740 is an immunomodulator of biological origin used against recurrent respiratory infections in adults and children over 1 year of age.
49 children aged 2 to 8 years were followed for 12 months. The RU-41740 patients (n = 25) were older, taller and more ill (lower Shwachmann score) than the control group (n = 24). However, the RU-41740 group had significantly fewer URT infections (2.16) than the placebo group (3.63) over the 12 months (p = 0.05). The total infection time was shorter (17.12 vs 25.54 days, p = 0.12) and the duration of antibiotic treatment significantly shorter (12.28 vs 23.5 days, p = 0.03). The clinical (particularly gastrointestinal) and laboratory tolerability of RU-41740 were good.
RU-41740 provided prophylactic treatment against URT infections in these cystic fibrosis patients in whom infection is a serious threat. Further investigations with this drug are warranted.
KeywordsCystic Fibrosis Cystic Fibrosis Patient Nasal Polyp Drug Invest Recurrent Respiratory Infection
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