Tiotropium in asthmatic adolescents symptomatic despite inhaled corticosteroids: A randomised dose-ranging study

SummaryIntroductionTiotropium, a once-daily long-acting anticholinergic agent, has been shown to be an efficacious and safe add-on treatment for adults with symptomatic asthma, despite treatment with inhaled corticosteroids (ICS). A large proportion of asthmatic adolescents have symptomatic disease despite a wide range of therapeutic options. We investigated the efficacy and safety of three doses of tiotropium, administered in the evening (via Respimat® SoftMist™ inhaler), versus placebo in asthmatic adolescents symptomatic despite ICS treatment.MethodsThis randomised, double-blind, placebo-controlled, incomplete crossover study evaluated once-daily tiotropium 5 μg, 2.5 μg and 1.25 μg versus placebo in three 4-week treatment periods. Primary efficacy end point was change in peak forced expiratory volume in 1 s within 3 h post-dose from baseline (peak FEV1(0–3h)).ResultsFrom 139 enrolled patients, 105 were randomised to receive one of four treatment sequences. Peak FEV1(0–3h) response for tiotropium 5 μg was significantly greater versus placebo (p = 0.0043). Trough FEV1 responses were significantly greater for tiotropium 5 μg (p < 0.00001) and 1.25 μg (p = 0.0134) versus placebo, but not for 2.5 μg (p = 0.0975), while FEV1 area under the curve(0–3h) responses were significant for all doses (p = 0.00001–0.0398). Overall incidence of adverse events was balanced across treatment groups, with no dose-dependent observations. The majority of adverse events were mild to moderate in intensity.ConclusionThis first study of tiotropium in adolescents with symptomatic asthma demonstrates that tiotropium is well tolerated and efficacious as add-on to maintenance treatment with ICS.ClinicalTrials.gov identifier; NCT01122680

Presence of Human Bocavirus 1 in Hospitalised Children with Acute Respiratory Tract Infections in Latvia and Lithuania

Funding Information: This study was supported by Republic of China (Taiwan)-Republic of Latvia-Republic of Lithuania scientific collaboration project, "Establishing of the framework to track molecular epidemiology of Parvoviruses and to correlate sequence variability with different clinical manifestations" (Research Council of Latvia Nr. gr. 6-25/2012/0026, Research Council of Lithuania TAPLLT02/201) and by project Nr. RSU ZP 17/2013 "Epidemiology, pathogenicity of human Bocavirus (HBoV) species and possible association with lower respiratory tract illnesses and acute gastroenteritis in children". We are grateful to Rita Nikitenkiene and Irina Maksimova for technical help. Publisher Copyright: © 2016 by Zaiga Nora-Krūkle. Copyright: Copyright 2016 Elsevier B.V., All rights reserved.Human bocavirus 1 (HBoV1) is a parvovirus recently found to be a possible aetiologic agent of acute respiratory disease in children. We conducted the first clinical and molecular study on this virus in Latvia (LV) and Lithuania (LT). The aim of the study was to determine the occurrence of HBoV1 in respiratory tract samples taken from hospitalised children with acute respiratory tract infections in LV and LT. In total 186 children with age one to 50 months, and who fulfilled criteria of acute respiratory tract infection, including lower respiratory tract infections, with or without fever, were included in this study. A nasopharyngeal aspirate was obtained from each patient on admission. DNA was isolated and polimerase chain reaction (PCR) performed targeting the HBoV1 NS1sequence. HBoV1 positive samples were sequenced and phylogenetic analysis was performed. HBoV1 sequence was detected in 42 (32%) of 130 LV and in 8 (14%) of 56 LT samples. In LV the majority of patients with HBoV1 infection were observed in February while in LT in October. The phylogenetic tree for HBoV1 indicated that isolates of HBoV1 cluster closely and include almost all of the isolates in this study. HBoV1 is common in Latvia and Lithuania and might be a significant pathogen that contributes to acute respiratory tract infections in children.Peer reviewe