Safety and efficacy of tiotropium in children aged 1–5 years with persistent asthmatic symptoms: a randomised, double-blind, placebo-controlled trial

Vrijlandt, Elianne J.L.E.; Azzi, Georges El; Vandewalker, Mark; Rupp, Ned T.; Harper, Thomas B.; Graham, LeRoy M.; Szefler, Stanley J.; Moroni-Zentgraf, Petra; Sharma, Ashish; Vulcu, Sebastian D.; Sigmund, Ralf; Chawes, Bo; Engel, Michael; Bisgaard, Hans

doi:10.1016/s2213-2600(18)30012-2

Cited by 65 publications

(80 citation statements)

References 26 publications

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“…Our in vitro findings are confirmed by the results of the PK studies, in which exposure to tiotropium was comparable between age groups when normalized for body surface area, suggesting that children in the NinoTinA-asthma ® trial were not overexposed to tiotropium [21]. These findings support the safety evaluation in this age group, and also indicate adequacy of both exposure to tiotropium and dosing.…”

Section: Tablesupporting

confidence: 83%

“…Details of the study design and patient selection for NinoTinA-asthma ® have been described elsewhere [21]. In brief, NinoTinA-asthma ® was a randomized, double-blind, placebo-controlled, parallel-group, multicentre trial (NCT01634113) across 32 sites in 11 countries in Asia, Europe, and North America.…”

Section: Comparison Of Respimat ® With and Without Test Vhc Using A Cmentioning

confidence: 99%

“…Detailed results of NinoTinA-asthma ® have been published elsewhere [21]. In brief, 102 of the enrolled 129 patients were randomized to either tiotropium 2.5 μg (n = 36), tiotropium 5 μg (n = 32), or placebo (n = 34).…”

Section: Ninotina-asthma ® Efficacy and Safetymentioning

confidence: 99%

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In vitro and clinical characterization of the valved holding chamber AeroChamber Plus ® Flow-Vu ® for administrating tiotropium Respimat ® in 1–5-year-old children with persistent asthmatic symptoms

Wachtel

Nagel

Engel

et al. 2018

Respiratory Medicine

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Section: Tablesupporting

confidence: 83%

Section: Comparison Of Respimat ® With and Without Test Vhc Using A Cmentioning

confidence: 99%

See 1 more Smart Citation

In vitro and clinical characterization of the valved holding chamber AeroChamber Plus ® Flow-Vu ® for administrating tiotropium Respimat ® in 1–5-year-old children with persistent asthmatic symptoms

Wachtel

Nagel

Engel

et al. 2018

Respiratory Medicine

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“…placebo for the 5mcg dose. NinoTinA-asthma® [ 33 ] (NCT01634113) Vrijlandt EJLE, El Azzi G , Vandewalker M , et al Safety and efficacy of tiotropium in children aged 1–5 years with persistent asthmatic symptoms: a randomised, double-blind, placebo-controlled trial. Lancet Respir Med.…”

Section: Pharmacological Managementmentioning

confidence: 99%

What is New in the Management of Childhood Asthma?

2018

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Asthma still causes considerable morbidity and mortality globally and minimal improvement has been seen in key outcomes over the last decade despite increasing treatment costs. This review summarizes recent advances in the management of asthma in children and adolescents. It focuses on the need for personalized treatment plans based on heterogenous asthma pathophysiology, the use of the terminology ‘asthma attack’ over exacerbation to instill widespread understanding of severity, and the need for every attack to trigger a structured review and focused strategy. The authors discuss difficulties in diagnosing asthma, accuracy and use of Fractional exhaled nitric oxide both as second line test and as a method to monitor treatment adherence or guide the choice of pharmacotherapy. The authors discuss acute and long-term management of asthma. Asthma treatment goals are to minimize symptom burden, prevent attacks and (where possible) reduce risk and impact of progressive pathophysiology and adverse outcomes. The authors discuss pharmacological management; optimal use of short acting β2 agonists, long acting muscarinic antagonist (tiotropium), use of which is relatively new in pediatrics, allergen specific immunotherapy, biological monoclonal antibody treatment, azalide antibiotic azithromycin, and the use of vitamin D. They also discuss electronic monitoring and adherence devices, direct observation of therapy via mobile device, temperature controlled laminar airflow device, and the importance of considering when symptoms may actually result from dysfunctional breathing rather than asthma.

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“…Although daily or pre-emptive high-dose inhaled corticosteroids (ICS) as monotherapy have been identified as effective management strategies for preschool asthma,7 50% still require rescue OCS within 6 months 8–10. Yet, in case of treatment failure, there is no official recommendation for step-up therapy as there is only one published trial in preschool-aged children testing the benefit of adjunct therapy to ICS 11. The dearth in knowledge to manage high-morbidity preschoolers with ongoing exacerbations despite ICS monotherapy underlines the crucial need for new prevention strategies 12…”

Section: Introductionmentioning

confidence: 99%

Vitamin D in the prevention of exacerbations of asthma in preschoolers (DIVA): protocol for a multicentre randomised placebo-controlled triple-blind trial

et al. 2019

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IntroductionPreschoolers have the highest rate of emergency visits and hospitalisations for asthma exacerbations of all age groups, with most triggered by upper respiratory tract infections (URTIs) and occurring in the fall or winter. Vitamin D insufficiency is highly prevalent in Canadian preschoolers with recurrent asthma exacerbations, particularly in winter. It is associated with more URTIs and, in patients with asthma, more oral corticosteroid (OCS) use. Although evidence suggests that vitamin D supplements significantly decrease URTIs and asthma exacerbations requiring OCS, there is insufficient data in preschoolers. This study aims to determine the impact of vitamin D3 supplementation on exacerbations requiring OCS, in preschoolers with recurrent URTI-induced asthma exacerbations.Methods and analysisThis is a phase III, randomised, triple-blind, placebo-controlled, parallel-group multicentre trial of vitamin D3 supplementation in children aged 1–5 years, with asthma triggered by URTIs and a recent history of frequent URTIs and OCS use. Children (n=865) will be recruited in the fall and early winter and followed for 7 months. They will be randomised to either the (1) intervention: two oral boluses of 100 000 international unit (IU) vitamin D3 (3.5 months apart) with 400 IU vitamin D3 daily; or (2) control: identical placebo boluses with daily placebo. The primary outcome is the number of exacerbations requiring OCS per child, documented by medical and pharmacy records. Secondary outcomes include number of laboratory-confirmed viral URTIs, exacerbation duration and severity, parent functional status, healthcare use, treatment deintensification, cost and safety.Ethics and disseminationThis study has received ethical approval from all sites. Results will be disseminated via international conferences and manuscripts targeting paediatricians and respirologists, and to families of asthmatic children via our Quebec parents–partners outreach programme. If proven effective, findings may markedly influence the management of URTI-induced asthma in high-morbidity preschoolers and could be directly implemented into practice with an update to clinical guidelines.Trial registration numberNCT03365687.

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Safety and efficacy of tiotropium in children aged 1–5 years with persistent asthmatic symptoms: a randomised, double-blind, placebo-controlled trial

Cited by 65 publications

References 26 publications

In vitro and clinical characterization of the valved holding chamber AeroChamber Plus ® Flow-Vu ® for administrating tiotropium Respimat ® in 1–5-year-old children with persistent asthmatic symptoms

In vitro and clinical characterization of the valved holding chamber AeroChamber Plus ® Flow-Vu ® for administrating tiotropium Respimat ® in 1–5-year-old children with persistent asthmatic symptoms

What is New in the Management of Childhood Asthma?

Vitamin D in the prevention of exacerbations of asthma in preschoolers (DIVA): protocol for a multicentre randomised placebo-controlled triple-blind trial

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