Lung Deposition Using the Respimat® Soft Mist™ Inhaler Mono and Fixed-Dose Combination Therapies: An In Vitro/In Silico Analysis

Ciciliani, Anna-Maria; Denny, Mark W.; Langguth, Peter; Voshaar, Thomas; Wachtel, H.

doi:10.1080/15412555.2020.1853091

Cited by 10 publications

(9 citation statements)

References 41 publications

(68 reference statements)

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“…6 In this study, clinically significant lung function improvement was seen in all subgroups, from <45 L/min to ≥80 L/min. Several studies of various inhaler types have extrapolated in vivo and in vitro modeling data to assume improvements in lung function at different inspiratory flow rates, 10,28,30,31 but clinical data to support these assumptions are limited. The efficacy of single bronchodilator therapy delivered via a handheld device in patients with different inhalation abilities has previously been reported, 32 but to our knowledge, this is the first study to investigate the relationship between PIF and efficacy in the context of dual bronchodilator therapy delivered via a handheld device.…”

Section: Discussionmentioning

confidence: 99%

“…This supports in vitro data from Ciciliani et al, which found high lung deposition in patients using the Respimat SMI, regardless of PIF. 28 Low PIF is a patient-related factor associated with suboptimal use of DPIs, 6,8,30,33 but there is limited evidence regarding its effect on lung function in patients with COPD. According to the GOLD 2021 strategy report, regular inhaler assessment is recommended and healthcare professionals should select the inhaler device that matches FEV 1 AUC 0-3h analyzed using an analysis of covariance model including the fixed categorical effects of treatment and the fixed continuous effect (FEV 1 ) of baseline.…”

Section: Discussionmentioning

confidence: 99%

“…21,[25][26][27] In vitro/in silico data suggest that the SMI delivers high lung deposition even at low modeled flow rates and across moderate-to-severe COPD inhalation profiles. 28 However, there are no data on the efficacy of tiotropium/olodaterol SMI in patients with COPD of different inhalation abilities. We anticipate no difference in outcomes according to PIF status.…”

Section: Introductionmentioning

confidence: 99%

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TRONARTO: A Randomized, Placebo-Controlled Study of Tiotropium/Olodaterol Delivered via Soft Mist Inhaler in COPD Patients Stratified by Peak Inspiratory Flow

Mahler

Ludwig-Sengpiel²,

Ferguson³

et al. 2021

COPD

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Background: Inhaled bronchodilator therapy is currently the mainstay of treatment for patients with chronic obstructive pulmonary disease (COPD). Some inhalers require patients to achieve certain inhalation efforts either to activate the device or to deliver medication to the site of action. For dry powder inhalers, low peak inspiratory flow (PIF) can result in poor medication delivery but the clinical significance of this is not well understood. Methods: TRONARTO was a 4-week, randomized, double-blind, placebo-controlled, multicenter, parallel-group study which stratified patients with moderate-to-severe COPD according to their PIF against medium-low resistance at screening. Patients were randomized to receive tiotropium/olodaterol (5 μg/5 μg) or matched placebo delivered via the Respimat ® Soft Mist™ inhaler (SMI). After 4 weeks of treatment, we assessed change from baseline in forced expiratory volume in 1 second (FEV 1 ) area under the curve 0-3 hours (FEV 1 AUC 0-3h ) and trough FEV 1 . Results: Overall, 213 patients were randomized, of whom 106 received tiotropium/olodaterol (PIF <60 L/min, 55; PIF ≥60 L/min, 51) and 107 received placebo (PIF <60 L/min, 55; PIF ≥60 L/min, 52). For FEV 1 AUC 0-3h , the adjusted mean change from baseline versus placebo was 336 mL (95% confidence interval [CI] 246-425 mL; P<0.0001) in the PIF <60 L/min group and 321 mL (95% CI 233-409 mL; P<0.0001) in the PIF ≥60 L/min group. For trough FEV 1 , the adjusted mean change from baseline versus placebo was 201 mL (95% CI 117-286 mL; P<0.0001) in the PIF <60 L/min group and 217 mL (95% CI 135-299 mL; P<0.0001) in the PIF ≥60 L/min group. Conclusion:In the TRONARTO study, which included patients with moderate-to-severe COPD and varying inspiratory flow abilities, treatment with tiotropium/olodaterol resulted in significant lung function improvements versus placebo. This SMI can be used irrespective of the PIF that a patient can generate.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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TRONARTO: A Randomized, Placebo-Controlled Study of Tiotropium/Olodaterol Delivered via Soft Mist Inhaler in COPD Patients Stratified by Peak Inspiratory Flow

Mahler

Ludwig-Sengpiel²,

Ferguson³

et al. 2021

COPD

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“…Моделирование потока в дыхательных путях больных астмой показало, что по уровню легочной депозиции Респимат существенно превосходит такие ингаляторы, как Бризхалер, Дженуэйр и Эллипта [19][20][21] (рис. 3).…”

Section: рисунок 1 конструкция респиматаunclassified

“…В одном из последних исследований депозиции Спиривы Респимата и Спиолто Респимата in silico [20] Рисунок 2. Распределение препарата (в % от дозы) в легких и ротоглотке у больных хронической обструктивной болезнью легких после ингаляции через дозированный аэрозольный ингалятор (ДАИ), порошковый ингалятор Турбухалер и Респимат Actual in pulmonology было показано, что тяжесть бронхообсрукции у больных ХОБЛ не влияет на степень доставки препарата через Респимат (рис.…”

Section: рисунок 1 конструкция респиматаunclassified

Respimat as the new standard for inhalation therapy devices

Архипов

2021

Medicinskij sovet

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The effectiveness of inhalation therapy can be significantly reduced by a number of problems. For example, inhalation technique errors can reduce the dose delivered by 22-95% compared to the optimal value in patients with technical errors in the use of the inhaler. Sub-optimal inspiratory flow rates in a number of patients with chronic obstructive pulmonary disease and asthma are often the cause of technical errors during inhalation. Patient education does not produce the expected results, as the underlying cause of reduced flow is high hyperinflation and weakening of the respiratory musculature. The use of technologically outdated inhalers is another significant cause of reduced therapy effectiveness. Patient education and even conversion to a different inhaler do not always increase the effectiveness of therapy. Respimat, a brand new delivery agent introduced in 2004, allows 39% to 67% of the nominal dose to be delivered to the airways, while the degree of pulmonary deposit is independent of inspiratory flow and pulmonary drug deposit does not decrease with increasing obstruction. Compared to powder inhalers, Respimat creates less resistance to airflow on inhalation. In addition, Respimat is an active device that requires no effort on the part of the patient to move the aerosol particles. These features make Respimat the new standard for inhalation therapy. This review aims to familiarise readers with the main features of the Respimat and the latest research findings

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Effect of Nasal Inhalation on Drug Particle Deposition and Size Distribution in the Upper Airway: With Soft Mist Inhalers

Sadeghi,

Fatehi,

Pakzad

2024

Ann Biomed Eng

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Lung Deposition Using the Respimat^® Soft Mist™ Inhaler Mono and Fixed-Dose Combination Therapies: An In Vitro/In Silico Analysis

Cited by 10 publications

References 41 publications

TRONARTO: A Randomized, Placebo-Controlled Study of Tiotropium/Olodaterol Delivered via Soft Mist Inhaler in COPD Patients Stratified by Peak Inspiratory Flow

TRONARTO: A Randomized, Placebo-Controlled Study of Tiotropium/Olodaterol Delivered via Soft Mist Inhaler in COPD Patients Stratified by Peak Inspiratory Flow

Respimat as the new standard for inhalation therapy devices

Effect of Nasal Inhalation on Drug Particle Deposition and Size Distribution in the Upper Airway: With Soft Mist Inhalers

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