Pooled analysis of tiotropium Respimat® pharmacokinetics in cystic fibrosis

Ashish Sharma*, David E. Geller, Petra Moroni-Zentgraf, Sabine Kattenbeck, Marion Schmid, Katja Boland, Barbara Rapp, Michael W. Konstan, Felix Ratjen, J. Stuart Elborn, Paul Koker

*Corresponding author for this work

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Tiotropium is the first bronchodilator to be studied systematically in cystic fibrosis (CF). We investigated whether any intrinsic or extrinsic factors affected pharmacokinetic (PK) parameters of inhaled tiotropium delivered by Respimat® in adults and children with CF. Tiotropium PK in patients with CF was compared with that of healthy volunteers and patients with chronic obstructive pulmonary disease (COPD). This pooled analysis summarizes the PK parameters of inhaled tiotropium Respimat® across 9 early- and late-phase trials involving 27 healthy volunteers (1 trial), 409 patients with CF (3 trials), and 281 patients with COPD (5 trials). Patients with CF aged 5 to 11, 12 to 17, and ≥18 years had similar tiotropium plasma concentrations (geometric mean C0.083,ss,norm: 2.22pg/mL/μg; not determined for patients aged <5 years). The fraction excreted unchanged in the urine was 3.4-fold lower for patients aged 0.4 to <5 years than for those aged 5 to 11 years (fe0-4,ss: 1.19% vs 4.09%). Tiotropium PK parameters were similar between CF patients and COPD patients.

Original languageEnglish
Pages (from-to)217-223
Number of pages7
JournalPulmonary Pharmacology and Therapeutics
Volume29
Issue number2
Early online date24 Aug 2014
DOIs
Publication statusPublished - Dec 2014

Keywords

  • Cystic fibrosis
  • Pharmacokinetics
  • Respimat® inhaler
  • Tiotropium

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Pharmacology (medical)
  • Biochemistry, medical

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    Sharma, A., Geller, D. E., Moroni-Zentgraf, P., Kattenbeck, S., Schmid, M., Boland, K., Rapp, B., Konstan, M. W., Ratjen, F., Elborn, J. S., & Koker, P. (2014). Pooled analysis of tiotropium Respimat® pharmacokinetics in cystic fibrosis. Pulmonary Pharmacology and Therapeutics, 29(2), 217-223. https://doi.org/10.1016/j.pupt.2014.08.004