Safety, Tolerability, and Plasma Exposure of Tiotropium Respimat<sup>®</sup> in Children and Adults with Cystic Fibrosis

Konstan, Michael W.; Sharma, Ashish; Moroni-Zentgraf, Petra; Wang, Fei; Koker, Paul

doi:10.1089/jamp.2013.1115

Cited by 7 publications

(2 citation statements)

References 13 publications

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“…Eighty adult patients with CF have been treated with a long-term tiotropium therapy and were included in this study. Tiotropium is well tolerated in patients with CF consistent with the known safety profile in COPD [ 25 , 34 ].…”

Section: Discussionmentioning

confidence: 85%

Impact of Long-Term Tiotropium Bromide Therapy on Annual Lung Function Decline in Adult Patients with Cystic Fibrosis

et al. 2016

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BackgroundChronic lung disease is the leading cause of death in patients with Cystic Fibrosis (CF) and is often treated with bronchodilators. It is not known whether long-term tiotropium bromide treatment may have a positive impact on lung function.MethodsThis retrospective cohort study estimated annual lung function decline utilizing longitudinal data for forced expiratory volume in 1 s (FEV1).ResultsA total of 160 adult patients with CF were analyzed. The subjects treated for 24 months with tiotropium bromide had a significantly slower decline of mean annual change of FEV1 (treated: -0.3±4.0%; control: -2.3±5.0%; p = 0.0130). In patients with FEV1 ≥70% predicted, long-term tiotropium bromide treatment was associated with greater improvements in annual lung function decline (FEV1 ≥70% predicted: treated: +0.5±4.7%; control: -4.0±6.3%; p = 0.0132; FEV1 50–69% predicted: treated: -0.5±4.4%; control: -0.8±3.8%; p = 0.7142; FEV1 ≤49% predicted: treated: -0.6±3.4%; control: -2.4±4.8%; p = 0.0898).ConclusionThis study suggests that long-term tiotropium bromide treatment may be associated with reduced annual decline of FEV1 in patients with CF, particularly in adults with a mild degree of severity.

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Section: Discussionmentioning

confidence: 85%

Impact of Long-Term Tiotropium Bromide Therapy on Annual Lung Function Decline in Adult Patients with Cystic Fibrosis

et al. 2016

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“…Tiotropium delivered by the Respimat SMI has been trialed in patients with stable CF bronchiectasis, although to date its routine use is not supported by existing Phase III trials. Although spirometric improvements have been noted in both children and adults, 47 , 48 these data have not been corroborated in larger Phase III trials, nor have any differences translated in clinically relevant outcomes. 49 Boehringer Ingelheim, in its prescribing information for UK prescribers, does not recommend the use of tiotropium Respimat SMI in patients with CF.…”

Section: Tiotropium Respimat Smi In Cfmentioning

confidence: 96%

Long-term safety of tiotropium delivered by Respimat<sup>®</sup> SoftMist™ Inhaler: patient selection and special considerations

Tan

Say

Geake

2016

TCRM

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Tiotropium bromide is a long-acting inhaled muscarinic antagonist used in patients with chronic respiratory disease. It has been available since 2002 as a single-dose dry powder formulation via the HandiHaler® dry powder inhaler (DPI) device, and since 2007 as the Respimat® SoftMist™ Inhaler (SMI). The latter is a novel method of medication delivery that utilizes a multidose aqueous solution to deliver the drug as a fine mist. Potential benefits include more efficient drug deposition throughout the respiratory tract, reduced systemic exposure, and greater ease of use and patient satisfaction compared with the use of HandiHaler DPI. Although tiotropium bromide delivered via the HandiHaler DPI has been clearly shown to improve lung function, dyspnea, and quality of life and to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD), there is accumulating evidence regarding the use of tiotropium HandiHaler in other respiratory diseases characterized by airflow limitation, such as asthma and cystic fibrosis. Developed more recently, tiotropium delivered via the Respimat SMI appears to have a similar efficacy and safety profile to the HandiHaler DPI, and early data raising the possibility of safety concerns with its use in COPD have been refuted by more recent evidence. The benefits over the HandiHaler DPI, however, remain unclear. This paper will review the evidence for tiotropium delivered via the Respimat SMI inhaler, in particular as an alternative to the HandiHaler DPI, and will focus on the safety profile for each of the chronic lung diseases in which it has been trialed, as well as an approach to appropriate patient selection.

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Long-acting inhaled bronchodilators for cystic fibrosis

Smith

Edwards²

2017

Cochrane Database of Systematic Reviews

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Neither long-acting beta-2 agonists nor long-acting muscarinic antagonist bronchodilators demonstrate improvement in our primary outcome of FEV. No difference was observed between intervention and placebo in terms of quality of life or adverse events. The quality of evidence for the use of beta-2 agonists was very low. The use of a long-acting inhaled bronchodilator may help to reduce the burden of treatment for people with cystic fibrosis as it is taken less often than a short-acting inhaled bronchodilator, but future trials would benefit from looking at the effects on our primary outcomes (spirometric changes from baseline, quality of life and adverse effects) in the longer term.

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Safety, Tolerability, and Plasma Exposure of Tiotropium Respimat^® in Children and Adults with Cystic Fibrosis

Abstract: Tiotropium 2.5 μg or 5 μg inhaled via the Respimat® Soft Mist™ Inhaler once daily was well tolerated in patients with CF.

Cited by 7 publications

References 13 publications

Impact of Long-Term Tiotropium Bromide Therapy on Annual Lung Function Decline in Adult Patients with Cystic Fibrosis

Impact of Long-Term Tiotropium Bromide Therapy on Annual Lung Function Decline in Adult Patients with Cystic Fibrosis

Long-term safety of tiotropium delivered by Respimat<sup>®</sup> SoftMist™ Inhaler: patient selection and special considerations

Long-acting inhaled bronchodilators for cystic fibrosis

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Safety, Tolerability, and Plasma Exposure of Tiotropium Respimat® in Children and Adults with Cystic Fibrosis

Abstract: Tiotropium 2.5 μg or 5 μg inhaled via the Respimat® Soft Mist™ Inhaler once daily was well tolerated in patients with CF.

Cited by 7 publications

References 13 publications

Impact of Long-Term Tiotropium Bromide Therapy on Annual Lung Function Decline in Adult Patients with Cystic Fibrosis

Impact of Long-Term Tiotropium Bromide Therapy on Annual Lung Function Decline in Adult Patients with Cystic Fibrosis

Long-term safety of tiotropium delivered by Respimat<sup>&reg;</sup> SoftMist&trade; Inhaler: patient selection and special considerations

Long-acting inhaled bronchodilators for cystic fibrosis

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Safety, Tolerability, and Plasma Exposure of Tiotropium Respimat^® in Children and Adults with Cystic Fibrosis

Long-term safety of tiotropium delivered by Respimat<sup>®</sup> SoftMist™ Inhaler: patient selection and special considerations