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Tiotropium

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Tiotropium in Peadeatric asthma
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  11/7/2014 www.medscape.com/viewarticle/834204_printhttp://www.medscape.com/viewarticle/834204_print 1/3 www.medscape.comOctober 31, 2014 AUSTIN — In children with poorly controlled asthma, once-daily tiotropium delivered with the Respimat inhaler improves lung function when added to inhaled corticosteroids, with no apparent change in adverse effects, newresearch has shown.The drug and device combination is approved for the treatment of chronic obstructive pulmonary disease (COPD), andthe manufacturer, Boehringer Ingelheim, is exploring US Food and Drug Administration approval for asthma. Anticholinergic medications have long been used to treat acute asthma attacks, but recent evidence suggests that theycould be useful as maintenance therapy in refractory patients. That got Boehringer Ingelheim interested in looking at the asthma part of this, not just COPD, said MarkVandewalker, MD, principal investigator for clinical research at The Ozarks in Columbia, Missouri. He presented theresearch here at CHEST 2014.In adults with asthma, the combination is an effective add-on to inhaled corticosteroids ( N Engl J Med  . 2012;367:1198-1207), so this study looked specifically at a pediatric population.The 48-week phase 3 trial involved adolescents who had asthma for at least 3 months, a forced expiratory volume in1 second (FEV ₁ ) predicted of 60% to 90%, and a score of at least 1.5 on the Asthma Control Questionnaire 6-pointscale.The age range was 12 to 17 years, 65% of the cohort was male, mean asthma duration was 7.86 years, and meanbaseline FEV ₁ % predicted was 82.8.Participants had not smoked in the previous year or had never smoked. They were randomized to receive once-dailytiotropium, either 5 μg or 2.5 μg, or placebo, all delivered with the Respimat inhaler. The drug was given as an add-onto inhaled corticosteroids, in doses of budesonide 200 to 400 µg or equivalent for 12- to 14-years-olds and 400 to800 µg for 14- to 17-years-olds.The primary end point was peak FEV ₁  in the 3 hours after dosing at week 24. The secondary end point was trough(predose) FEV ₁  at week 24, which was measured 10 minutes before receiving that day's dose. FEV ₁  peak in the 3hours after the dosing and trough responses were also measured at week 48. Table 1. Peak FEV ₁  for Tiotropium Compared With Placebo Variable Adjusted Mean Difference (mL)  P   ValueTiotropium 5 μg  Week 24 FEV ₁  area under the curve 174 .0005 Week 48 FEV ₁  3 hours after dosing 174 .0006 Tiotropium 2.5 μg  Week 24 FEV ₁  area under the curve 134 .0085 Week 48 FEV ₁  3 hours after dosing 176 .0007 Tiotropium Showing Promise in Pediatric Asthma Jim Kling  11/7/2014 www.medscape.com/viewarticle/834204_printhttp://www.medscape.com/viewarticle/834204_print 2/3   Table 2. Trough FEV ₁  for Tiotropium Compared With Placebo Trough FEV ₁  Adjusted Mean Difference (mL)  P   ValueTiotropium 5 μg  Week 24 117 .0320 Week 48 157 .0044 Tiotropium 2.5 μg  Week 24 — ns Week 48 137 .0154  The adverse-event profile was similar in all three groups, except there were some differences in drug-related adverseevents and headache. You might think dry mouth would be a concern, and so far it hasn't been, said Dr Vandewalker. My thought is thatthat's due to the Respimat device. We do see dry mouth with the older HandiHaler device. Table 3. Incidence of Adverse Events Adverse Events Tiotropium 5 μg (n = 134), % Tiotropium 2.5 μg (n = 125), % Placebo (n = 138), % One or more 62.7 63.2 59.4Severe 1.5 1.6 2.2Drug-related 3.0 0.8 0.7Headache 6.7 5.6 1.4  For children whose asthma is not under control, the drug could be a useful option. It looks like it was a beneficialtreatment. So far, the teenagers are responding in a manner similar to adults — in fact more robustly — which we kindof expect because they haven't had asthma quite as long, so have less damage to their airways. The safety profile hasbeen as good as, if not better than, that seen in adults, Dr Vandewalker added.The drug would be a welcome addition to pediatric asthma care, according to Chris Carroll, MD, from the University of Connecticut in Hartford, who attended the poster presentation. For children with refractory asthma who are on moderate steroids and not well controlled, it would be really nice tohave other options. It's great that they're doing pediatric studies because for a lot of medications, they don't bother, hetold Medscape Medical News .He said he finds the data reassuring. I don't have any specific concerns about safety for this medication, Dr Carrollsaid.  11/7/2014 www.medscape.com/viewarticle/834204_printhttp://www.medscape.com/viewarticle/834204_print 3/3 This study was funded by Boehringer Ingelheim. Dr Vandewalker has received research report from the company. Dr Carroll disclosed no relevant financial relationships. CHEST 2014: American College of Chest Physicians Meeting: Abstract 1994584. Presented October 29, 2014.Medscape Medical News © 2014 WebMD, LLC Send comments and news tips to news@medscape.net. Cite this article: Tiotropium Showing Promise in Pediatric Asthma. Medscape . Oct 31, 2014.
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