Tiotropium Respimat® in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials

Felix Ratjen*, Paul Koker, David E. Geller, Berengere Langellier-Cocteaux, Florence Le Maulf, Sabine Kattenbeck, Petra Moroni-Zentgraf, J. Stuart Elborn

*Corresponding author for this work

Research output: Contribution to journalArticle

9 Citations (Scopus)
339 Downloads (Pure)

Abstract

Background: Tiotropium Respimat® improved lung function in a phase 2 trial in patients with cystic fibrosis (CF). We investigated its efficacy and safety in a phase 3 trial, including a pre-specified pooled analysis of the phase 2 and 3 trials. 

Methods: 12-week, randomized, double-blind, placebo-controlled trial of tiotropium Respimat® 5. μg once daily in patients with CF (N = 463). 

Results: Co-primary efficacy endpoints showed no statistical difference between tiotropium and placebo: percent-predicted forced expiratory volume in 1s (FEV1) area under the curve from 0-4h (AUC0-4h) (95% CI): 1.64% (0.27,3.55; p=0.092); percent-predicted trough FEV1 (95% CI) 1.40% (0.50,3.30; p=0.15). Adverse events were similar between groups. Pooled phase 2/3 trial results showed a treatment difference in favor of tiotropium: percent-predicted FEV1 AUC0-4h (95% CI): 2.62% (1.34,3.90). 

Conclusion: Tiotropium was well tolerated in patients with CF; lung function improvements compared with placebo were not statistically significant in the phase 3 trial. Clinical trials: These studies are registered with clinical trial identifier numbers NCT00737100 and NCT01179347NCT00737100NCT01179347. These studies are also registered with the EudraCT number: 2008-001156-43 and 2010-019802-17.

Original languageEnglish
Pages (from-to)608-614
Number of pages7
JournalJournal of Cystic Fibrosis
Volume14
Issue number5
Early online date26 Mar 2015
DOIs
Publication statusPublished - Sep 2015

Bibliographical note

Copyright © 2015. Published by Elsevier B.V.

Keywords

  • Bronchodilator
  • Cystic fibrosis
  • Respimat
  • Tiotropium

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Pediatrics, Perinatology, and Child Health

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