Testing two different doses of tiotropium Respimat® in cystic fibrosis: Phase 2 randomized trial results
Data(s) |
04/09/2014
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Resumo |
<p>Background: Tiotropium is a once-daily, long-acting anticholinergic bronchodilator with the potential to alleviate airway obstruction in cystic fibrosis. Our objective was to evaluate the efficacy and safety of 2.5 and 5 μg once-daily tiotropium delivered via the Respimat Soft Mist Inhaler vs. placebo in people with cystic fibrosis. Methods: This phase 2, 12-week, randomized, double-blind, placebo-controlled parallel-group study of tiotropium Respimat as add-on to usual cystic fibrosis maintenance therapy included people with cystic fibrosis with pre-bronchodilator forced expiratory volume in 1 second (FEV<sub>1</sub>) ≥25% predicted. Co-primary efficacy end points were change from baseline in percent-predicted FEV<sub>1</sub>area under the curve from 0 to 4 hours (FEV<sub>1</sub>AUC<sub>0-4h</sub>), and trough FEV<sub>1</sub>at the end of week 12. Findings: A total of 510 subjects with cystic fibrosis aged 5-69 years were randomized. Both doses of tiotropium resulted in significant improvement compared with placebo in the co-primary efficacy end points at the end of week 12 (change from baseline in percent-predicted FEV<sub>1</sub>AUC<sub>0-4h</sub>: 2.5 μg: 2.94%, 95% confidence interval 1.19-4.70, p = 0.001; 5 μg: 3.39%, 95% confidence interval 1.67-5.12, p = 0.0001; in percent-predicted trough FEV<sub>1</sub>:2.5 μg: 2.24%, p = 0.2; 5 μg: 2.22%, p = 0.02). There was a greater benefit with tiotropium 5 vs. 2.5 μg. No treatment-related adverse events or unexpected safety findings were observed in patients taking tiotropium. Conclusions: Tiotropium significantly improved lung function in people with cystic fibrosis. The improvement was greater with the higher dose than the lower dose, with no difference in adverse events.</p> |
Formato |
application/pdf |
Identificador | |
Idioma(s) |
eng |
Direitos |
info:eu-repo/semantics/openAccess |
Fonte |
Bradley , J M , Koker , P , Deng , Q , Moroni-Zentgraf , P , Ratjen , F , Geller , D E & Elborn , S 2014 , ' Testing two different doses of tiotropium Respimat® in cystic fibrosis: Phase 2 randomized trial results ' PLoS ONE , vol 9 , no. 9 , e106195 , pp. 1-9 . DOI: 10.1371/journal.pone.0106195 |
Palavras-Chave | #/dk/atira/pure/subjectarea/asjc/1100 #Agricultural and Biological Sciences(all) #/dk/atira/pure/subjectarea/asjc/1300 #Biochemistry, Genetics and Molecular Biology(all) #/dk/atira/pure/subjectarea/asjc/2700 #Medicine(all) |
Tipo |
article |