Randomized Trial of Once-Daily Fluticasone Furoate in Children with Inadequately Controlled Asthma

Oliver, Amanda J.; Covar, Ronina; Goldfrad, Caroline; Klein, Ryan M.; Pedersen, Søren; Sorkness, Christine A.; Tomkins, Susan A.; Villarán, César; Grigg, Jonathan

doi:10.1016/j.jpeds.2016.08.010

Cited by 8 publications

(6 citation statements)

References 22 publications

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“…An examination of the maximum concentration of FF achieved after dosing (C max ) from other pediatric studies [7][8][9] indicated that the average C max obtained in the current study (~ 12 pg/mL) was dose proportional with the values reported in the literature. The median C max observed in this study was also consistent with the predicted average C max in the pediatric population PK analysis (11.6 pg/mL for FF 50 μg) [7].…”

Section: Discussionsupporting

confidence: 55%

“…In the current study, plasma FF concentrations were measured using pre-dose and 30 min post-dose blood samples, since the median t max following inhaled administration of FF or FF/VI is around 0.5 h [5,23]. An examination of the maximum concentration of FF achieved after dosing (C max ) from other pediatric studies [7][8][9] indicated that the average C max obtained in the current study (~ 12 pg/mL) was dose proportional with the values reported in the literature. The median C max observed in this study was also consistent with the predicted average C max in the pediatric population PK analysis (11.6 pg/mL for FF 50 μg) [7].…”

Section: Discussionmentioning

confidence: 99%

“…The safety of inhaled FF in combination with the longacting β 2 -agonist vilanterol (VI) on the HPA axis in adult and adolescent (12-17 years of age) patients with asthma has been established [6]. A phase 2b, doseresponse, efficacy and safety study showed that FF was effective and well tolerated in children aged 5-11 years with uncontrolled asthma [7]. Two randomized, doubleblind, crossover studies of FF 100 µg or FF/VI 100/25 µg found no evidence of serum cortisol (SC) suppression in children (aged 5-11 years) with persistent asthma, suggesting this FF dose does not affect the HPA axis in this patient population [8,9].…”

Section: Introductionmentioning

confidence: 99%

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A randomized, double-blind, placebo-controlled, parallel-group study of once-daily inhaled fluticasone furoate on the hypothalamic–pituitary–adrenocortical axis of children with asthma

Bareille

Tomkins

Imber

et al. 2020

Allergy Asthma Clin Immunol

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Background: To evaluate the effects of fluticasone furoate on the hypothalamic-pituitary-adrenocortical axis, and the safety and tolerability of fluticasone furoate treatment in children with asthma. Methods: This was a randomized, double-blind, placebo-controlled, multicenter, stratified, parallel-group, noninferiority study of fluticasone furoate 50 µg inhalation powder administered once daily. The study enrolled children (aged 5-11 years inclusive) with a documented diagnosis of asthma for ≥ 6 months and a Childhood Asthma Control Test score of > 19. After a 7-14-day run-in period, eligible subjects were stratified by age and randomized to fluticasone furoate 50 µg once daily or placebo once daily via ELLIPTA for 6 weeks. The primary endpoint was the change from baseline (expressed as a ratio) in 0-24-h weighted mean serum cortisol at the end of the treatment period. Results: Fifty-six randomized subjects received fluticasone furoate 50 µg once daily and 55 received placebo. The primary analysis was performed in the serum cortisol population (n = 104) and demonstrated that fluticasone furoate 50 µg once daily was non-inferior to placebo (ratio = 0.93; 95% confidence interval 0.8096, 1.0620), as the lower limit of the 95% confidence interval for the geometric mean treatment ratio of fluticasone furoate 50 µg once daily versus placebo was greater than 0.80. Findings from the intent-to-treat population (n = 111) were similar. Conclusions: Six weeks of treatment with inhaled fluticasone furoate 50 µg once daily had no clinically relevant effect on the hypothalamic-pituitary-adrenocortical axis function of children, as measured by 24-h serum cortisol profiles. The primary analysis showed that fluticasone furoate 50 µg once daily was non-inferior to placebo. Fluticasone furoate 50 µg once daily was well tolerated and no new safety concerns emerged during the study.

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Section: Discussionsupporting

confidence: 55%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A randomized, double-blind, placebo-controlled, parallel-group study of once-daily inhaled fluticasone furoate on the hypothalamic–pituitary–adrenocortical axis of children with asthma

Bareille

Tomkins

Imber

et al. 2020

Allergy Asthma Clin Immunol

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show abstract

“…Com isso, é possível observar no Quadro 1 a composição final dessa revisão, com a titulação dos trabalhos, além dos autores, ano e país, os objetivos e resultados dos estudos selecionados. A asma não controlada em crianças é potencialmente preocupante, pois pode afetar diretamente a qualidade de vida desses pacientes, retardando seu crescimento, influenciando diretamente no sono, além da prática de exercícios físicos e ausência escolar (Oliver et al, 2016). Assim, é bem descrito nas diretrizes nacionais e internacionais a importância do uso de CI para o tratamento dessa enfermidade em crianças (Singh et al, 2016).…”

Section: Resultsunclassified

Efetividade e segurança da corticoterapia inalatória em crianças e adolescentes asmáticos

Oliveira¹,

Sousa²,

Carvalho³

et al. 2021

RSD

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O objetivo deste estudo foi investigar o uso de corticosteroides inalatórios (CI) no tratamento da asma, em crianças e adolescentes, com a finalidade de fornecer informações relevantes e atuais para assegurar um tratamento mais seguro e efetivo. Foi realizada uma revisão sistemática na literatura disponível nas bases de dados PubMed, Scielo e ScienceDirect, utilizando como descritores: asthma, corticosteroids, drug therapy e children. Foram incluídos artigos na categoria original, disponibilizados na íntegra, publicados nos idiomas português, inglês e espanhol, com intervalo de 2016 a 2021. Dos 233 estudos encontrados, 14 foram selecionados. Na pesquisa observou-se a influência que o tamanho de partícula tem sobre a efetividade e segurança do tratamento, alterando a disponibilidade do medicamento no órgão alvo e a dosagem administrada para promover o efeito desejado. Ademais, as particularidades dos CI disponíveis no mercado que podem ser utilizados isoladamente ou em combinações com β2-agonistas adrenérgicos, nas quais essas permitem uma redução da dose de CI usado, diminuindo assim a incidência de possíveis reações adversas à medicamentos (RAM). É importante ressaltar que a fluticasona mostrou-se como um dos medicamentos mais seguros quando foi analisada sua influência sobre o crescimento de crianças e adolescentes. Por último, apesar da gama de estudos na área, é necessário que novas pesquisas sobre esse tema sejam realizadas, principalmente aquelas que envolvam a influência do tamanho de partícula na efetividade e segurança do tratamento, bem como as principais RAM acerca do tema proposto.

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“…Our findings support the use of ELLIPTA DPI in pediatric patients with asthma. Fluticasone furoate (delivered via ELLIPTA DPI) has previously demonstrated improvements to lung function in pediatric patients with asthma, 17 and is approved for the treatment of patients ≥5 years of age in the US 10 . Research into the use of fluticasone furoate/vilanterol combination therapy, also delivered via ELLIPTA DPI, is ongoing.…”

Section: Discussionmentioning

confidence: 99%

The evaluation of the correct use and ease‐of use of the ELLIPTA DPI in children with asthma

Halverson

Liem²,

Heyes

et al. 2020

Pediatric Pulmonology

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Rationale Asthma studies show many children use inhalers incorrectly even after instruction. For two age groups of children with asthma, we determined the proportions who used the once‐daily ELLIPTA dry‐powder inhaler (DPI) correctly, and who found it easy to use. Methods This was a multicenter, single‐arm, stratified, open‐label, placebo study (NCT03478657). Children aged 5–7 and 8–11 years were trained in, and required to demonstrate, correct placebo ELLIPTA DPI use at their first clinic visit. The inhaler was used at home once daily for 28 ± 2 days. On returning to the clinic, children were randomized to an age‐appropriate, ease‐of‐use questionnaire that had been developed and validated previously, and which rated the inhaler as “easy” or “hard” to use. Following questionnaire completion, children were then asked to demonstrate correct inhaler use. Correct use and ease‐of use were assessed in each age group (co‐primary endpoints) and overall (secondary endpoints). Results Of 222 enrolled children, 221 completed the study. Among children aged 5–7 years, 92% (n = 81/88) demonstrated correct ELLIPTA use on their first attempt, compared with 93% (n = 124/133) aged 8–11 years. Of these children, 98% (5–7 years: n = 79/81; 8–11 years: n = 121/124) rated the inhaler easy to use. Overall, 93% (n = 205/221) demonstrated correct inhaler use on their first attempt, and 98% (n = 200/205) rated it easy to use. Conclusion ELLIPTA DPI was used correctly and easily by most children on their first attempt without additional training.

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Randomized Trial of Once-Daily Fluticasone Furoate in Children with Inadequately Controlled Asthma

Abstract: ClinicalTrials.gov:NCT01563029.

Cited by 8 publications

References 22 publications

A randomized, double-blind, placebo-controlled, parallel-group study of once-daily inhaled fluticasone furoate on the hypothalamic–pituitary–adrenocortical axis of children with asthma

A randomized, double-blind, placebo-controlled, parallel-group study of once-daily inhaled fluticasone furoate on the hypothalamic–pituitary–adrenocortical axis of children with asthma

Efetividade e segurança da corticoterapia inalatória em crianças e adolescentes asmáticos

The evaluation of the correct use and ease‐of use of the ELLIPTA DPI in children with asthma

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