Pharmacokinetics of tiotropium administered by Respimat® in asthma patients: Analysis of pooled data from Phase II and III clinical trials

Sharma, Ashish; Kerstjens, Huib A. M.; Aalbers, Rick; Moroni-Zentgraf, Petra; Weber, Benjamin; Dahl, Ronald

doi:10.1016/j.pupt.2016.12.003

Cited by 12 publications

(5 citation statements)

References 10 publications

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“…Compared with COPD patients, the peak plasma concentration in patients with asthma was approximately 52%, with no difference in exposure comparing the once daily and twice daily administration regimens. Age, allergic status, race, geographical region and smoking history did not appeared to influence the systemic exposure to tiotropium in patients with asthma [88]. In the numerous randomized clinical trials conducted in COPD [89], tiotropium showed an excellent and sustained bronchodilator effect [90], with proved efficacy in the reduction of static and dynamic volumes [91], in the reduction of the incidence of acute exacerbations [90], in the improvement of quality of life and symptoms [90], together with a good safety profile [91].…”

Section: Introductionmentioning

confidence: 99%

The evidence on tiotropium bromide in asthma: from the rationale to the bedside

Radovanovic

Santus

Blasi

et al. 2017

Multidiscip Respir Med

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Severe and poorly controlled asthma still accounts for a great portion of the patients affected. Disease control and future risk management have been identified by international guidelines as the main goals in patients with asthma. The need for new treatment approaches has led to reconsider anticholinergic drugs as an option for asthma treatment. Tiotropium is the first anticholinergic drug that has been approved for children and adults with poorly controlled asthma and is currently considered as an option for steps 4 and 5 of the Global Initiative for Asthma. In large randomized clinical trials enrolling patients with moderate to severe asthma, add-on therapy with tiotropium has demonstrated to be efficacious in improving lung function, decreasing risk of exacerbation and slowing the worsening of disease; accordingly, tiotropium demonstrated to be non inferior compared to long acting beta-agonists in the maintenance treatment along with medium to high inhaled corticosteroids. In view of the numerous ancillary effects acting on inflammation, airway remodeling, mucus production and cough reflex, along with the good safety profile and the broad spectrum of efficacy demonstrated in different disease phenotypes, tiotropium can represent a beneficial alternative in the therapeutic management of poorly controlled asthma. The present extensive narrative review presents the pharmacological and pathophysiological basis that guided the rationale for the introduction of tiotropium in asthma treatment algorithm, with a particular focus on its conventional and unconventional effects; finally, data on tiotropium efficacy and safety. from recent randomized clinical trials performed in all age categories will be extensively discussed.

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Section: Introductionmentioning

confidence: 99%

The evidence on tiotropium bromide in asthma: from the rationale to the bedside

Radovanovic

Santus

Blasi

et al. 2017

Multidiscip Respir Med

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“…A pharmacokinetic study in children aged 6–11 years old demonstrated that tiotropium bromide is rapidly absorbed following inhalation and then excreted into urine ( 21 ), confirming that systemic exposure of children to the medication is within the range observed in adults ( 22 ).…”

Section: Pharmacologic Characteristics Of Tiotropium Bromide and Its ...mentioning

confidence: 89%

Update on Long-Acting Anticholinergics in Children and Adolescents With Difficult and Severe Asthma

et al. 2022

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Tiotropium bromide is the only long-acting muscarinic antagonist (LAMA) approved for treatment of patients aged ≥6 years old who have symptoms of uncontrolled asthma. Results from several clinical trials have found that once-daily inhaled tiotropium bromide is safe and efficacious in 6- to 17-year-olds with symptomatic asthma despite treatment with inhaled corticosteroids, with or without other medications. There are still few available studies investigating the impact of tiotropium bromide treatment in preschool children with suboptimal control. In this narrative review, we summarize the pharmacological effects of the LAMA tiotropium bromide, provide an overview about current asthma studies at different pediatric ages, and describe future research needs.

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“…Pharmacokinetic parameters of tiotropium demonstrate its fast absorption and long elimination time, with maximum plasma concentrations reached within 5 minutes of post-inhalation and a half-life of approximately 30 hours 50. Furthermore, pharmacokinetics of tiotropium in adult patients with asthma are dose proportional up to 5 µg once daily 51…”

Section: Introductionmentioning

confidence: 99%

<p>Clinical efficacy and safety of anticholinergic therapies in pediatric patients</p>

Goldstein¹

2019

TCRM

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The burden of uncontrolled asthma in children and adolescents is high. Treatment options for pediatric patients (aged under 18 years) with asthma are largely influenced by the Global Initiative for Asthma recommendations. Algorithms for adolescents (12–18 years) and adults are identical, but recommendations for children aged under 6 years and 6–11 years differ. Although the goals of treatment for pediatric patients with asthma are similar to those for adults, relatively few new therapies have been approved for this patient population within the last decade. Designing clinical trials involving children presents several challenges, notably that children are often less able to perform lung function tests, and traditional endpoints used in clinical trials with adults, such as forced expiratory volume in 1 second, asthma exacerbations and questionnaires, have limitations associated with their use in children. There are also ethical considerations related to the performance of longer placebo-controlled exacerbation trials. This review considers additional clinical endpoints to those traditionally reported, including forced expiratory flow at 25%–75% of forced vital capacity, which may help shed light on which treatments are most effective for use in pediatric patients with asthma. The pros and cons of specific and potentially clinically relevant endpoints are considered, along with device considerations and patient preferences that may enhance adherence and quality of life. Recent advances in the management of children and adolescents, including the US Food and Drug Administration and European Medicines Agency approval of tiotropium in patients with asthma aged 6 years and over, are also discussed.

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Pharmacokinetics of tiotropium administered by Respimat® in asthma patients: Analysis of pooled data from Phase II and III clinical trials

Cited by 12 publications

References 10 publications

The evidence on tiotropium bromide in asthma: from the rationale to the bedside

The evidence on tiotropium bromide in asthma: from the rationale to the bedside

Update on Long-Acting Anticholinergics in Children and Adolescents With Difficult and Severe Asthma

<p>Clinical efficacy and safety of anticholinergic therapies in pediatric patients</p>

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