Abstract
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 (FEV1) ≥25% predicted. Co-primary efficacy end points were change from baseline in percent-predicted FEV1area under the curve from 0 to 4 hours (FEV1AUC0-4h), and trough FEV1at 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 FEV1AUC0-4h: 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 FEV1:2.5 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.
Original language | English |
---|---|
Article number | e106195 |
Pages (from-to) | 1-9 |
Number of pages | 9 |
Journal | PLoS ONE |
Volume | 9 |
Issue number | 9 |
DOIs | |
Publication status | Published - 04 Sep 2014 |
ASJC Scopus subject areas
- Agricultural and Biological Sciences(all)
- Biochemistry, Genetics and Molecular Biology(all)
- Medicine(all)
Fingerprint
Dive into the research topics of 'Testing two different doses of tiotropium Respimat® in cystic fibrosis: Phase 2 randomized trial results'. Together they form a unique fingerprint.Profiles
-
Judy Bradley
- School of Medicine, Dentistry and Biomedical Sciences - Director of Clinical Research Facility
- Wellcome Wolfson Institute for Experimental Medicine
Person: Academic