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

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

doi:10.1016/j.jcf.2015.03.004

Cited by 12 publications

(12 citation statements)

References 12 publications

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“…Other inhaled medications are used to provide bronchodilation, decrease inflammation, and facilitate mucus clearance. Tiotropium bromide did not demonstrate improvement in lung function compared to placebo . Inhalation of dry powder mannitol during pulmonary exacerbations did not lead to differences in lung function or clinical status, although there was a trend toward improvement in the lung clearance index .…”

Section: Therapiesmentioning

confidence: 70%

“…Tiotropium bromide did not demonstrate improvement in lung function compared to placebo. 86 Inhalation of dry powder mannitol during pulmonary exacerbations did not lead to differences in lung function or clinical status, although there was a trend toward improvement in the lung clearance index. 87 Glutathione has been shown to enhance the functional activity of different immune cells against oxidative stress-induced lung damage and is depleted in CF.…”

Section: Inhaled Medicationsmentioning

confidence: 85%

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Pediatric Pulmonologyyear in review 2015: Part 4

Savant

McColley

2016

Pediatr Pulmonol.

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Section: Therapiesmentioning

confidence: 70%

Section: Inhaled Medicationsmentioning

confidence: 85%

Pediatric Pulmonologyyear in review 2015: Part 4

Savant

McColley

2016

Pediatr Pulmonol.

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“…Adverse events were generally minor, with the most common being cough, pyrexia, and nasopharyngitis. 47 However, Ratjen et al 49 found a numerical, although not statistically significant, increase in the risk of infective exacerbations of CF in the tiotropium Respimat SMI group when compared to placebo. To the best of our knowledge, no studies have been performed to ascertain whether there is a similar signal with tiotropium HandiHaler DPI.…”

Section: Tiotropium Respimat Smi In Cfmentioning

confidence: 94%

“…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. 35…”

Section: Tiotropium Respimat Smi In Cfmentioning

confidence: 99%

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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“…With regard to CF, safety and efficacy of inhaled tiotropium were investigated in children and adults with CF in three randomized placebo-controlled multicenter trials with tiotropium treatment durations of ≤ 12 weeks [ 17 , 24 ]. Dosages of 2.5 and 5 μg inhaled tiotropium showed consistent improvement in lung function [ 24 , 25 ]. However, statistically significant differences in the measure of lung function were only reached in one study.…”

Section: Introductionmentioning

confidence: 99%

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

Cited by 12 publications

References 12 publications

Pediatric Pulmonologyyear in review 2015: Part 4

Pediatric Pulmonologyyear in review 2015: Part 4

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

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

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

Cited by 12 publications

References 12 publications

Pediatric Pulmonologyyear in review 2015: Part 4

Pediatric Pulmonologyyear in review 2015: Part 4

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

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

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