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Montelukast in the treatment of perennial allergic rhinitis in paediatric Japanese patients; an open-label clinical trial

Background: This study was conducted to evaluate the safety and tolerability, and population pharmacokinetics (PPK) of montelukast as well as efficacy in the treatment of perennial allergic rhinitis (PAR) in paediatric Japanese patients aged between 1 and 15 years. Methods: In this multi-centre, ope...

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Autores principales: Okubo, Kimihiro, Inoue, Yoichi, Numaguchi, Hirotaka, Tanaka, Kumi, Saito, Itori, Oshima, Nobuyuki, Matsumoto, Yuki, Prohn, Marita, Mehta, Anish, Nishida, Chisato, Philip, George
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5040008/
https://www.ncbi.nlm.nih.gov/pubmed/27785374
http://dx.doi.org/10.1080/21556660.2016.1209507
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author Okubo, Kimihiro
Inoue, Yoichi
Numaguchi, Hirotaka
Tanaka, Kumi
Saito, Itori
Oshima, Nobuyuki
Matsumoto, Yuki
Prohn, Marita
Mehta, Anish
Nishida, Chisato
Philip, George
author_facet Okubo, Kimihiro
Inoue, Yoichi
Numaguchi, Hirotaka
Tanaka, Kumi
Saito, Itori
Oshima, Nobuyuki
Matsumoto, Yuki
Prohn, Marita
Mehta, Anish
Nishida, Chisato
Philip, George
author_sort Okubo, Kimihiro
collection PubMed
description Background: This study was conducted to evaluate the safety and tolerability, and population pharmacokinetics (PPK) of montelukast as well as efficacy in the treatment of perennial allergic rhinitis (PAR) in paediatric Japanese patients aged between 1 and 15 years. Methods: In this multi-centre, open-label trial, 87 paediatric Japanese patients with PAR received montelukast 4 mg oral granules (OG) for 4 weeks (1–5-year-olds, N = 15), 4 mg OG for 12 weeks (1–5-year-olds, N = 36), 5 mg chewable tablets (CT) for 12 weeks (6–9-year-olds, N = 18), or 5 mg CT for12 weeks (10–15-year-olds, N = 18). Clinical exams and laboratory assessments were conducted at study visits, and adverse events (AE) were monitored throughout the study up to 14 days after the last visit. Population pharmacokinetic approach was used to estimate AUC(0–∞), C(max), T(max) and apparent elimination half-life in each age group. Efficacy was assessed based on global evaluations by the subject’s caregiver. Results: There were no serious AEs and one discontinuation due to an AE. The most common AEs in any of the treatment groups were nasopharyngitis, pharyngitis, and acute sinusitis. Montelukast exposure (AUC(0–∞)) was similar in the 1–5-year-old group and the 6–9-year-old group, but 19% lower in the 10–15-year-old group. Among all patients, the total proportion of patients whose global evaluation was “very much better” was 5.7% (week 2), 11.5% (week 4), and 16.9% (week 12) reflecting improvement in symptoms over time. Conclusion: Montelukast was generally well tolerated in Japanese children with PAR. AUC(0–∞)was similar in 1–5 and 6–9-year-olds, while a lower exposure was observed in the 10–15-year-old group likely due to differences in bodyweight. The exposure in Japanese paediatric patients was generally consistent with that in non-Japanese paediatric and adult patients. As assessed by the patients’ caregivers, montelukast also demonstrated symptomatic improvement based on global evaluations of PAR.
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spelling pubmed-50400082016-10-26 Montelukast in the treatment of perennial allergic rhinitis in paediatric Japanese patients; an open-label clinical trial Okubo, Kimihiro Inoue, Yoichi Numaguchi, Hirotaka Tanaka, Kumi Saito, Itori Oshima, Nobuyuki Matsumoto, Yuki Prohn, Marita Mehta, Anish Nishida, Chisato Philip, George J Drug Assess Original Article Background: This study was conducted to evaluate the safety and tolerability, and population pharmacokinetics (PPK) of montelukast as well as efficacy in the treatment of perennial allergic rhinitis (PAR) in paediatric Japanese patients aged between 1 and 15 years. Methods: In this multi-centre, open-label trial, 87 paediatric Japanese patients with PAR received montelukast 4 mg oral granules (OG) for 4 weeks (1–5-year-olds, N = 15), 4 mg OG for 12 weeks (1–5-year-olds, N = 36), 5 mg chewable tablets (CT) for 12 weeks (6–9-year-olds, N = 18), or 5 mg CT for12 weeks (10–15-year-olds, N = 18). Clinical exams and laboratory assessments were conducted at study visits, and adverse events (AE) were monitored throughout the study up to 14 days after the last visit. Population pharmacokinetic approach was used to estimate AUC(0–∞), C(max), T(max) and apparent elimination half-life in each age group. Efficacy was assessed based on global evaluations by the subject’s caregiver. Results: There were no serious AEs and one discontinuation due to an AE. The most common AEs in any of the treatment groups were nasopharyngitis, pharyngitis, and acute sinusitis. Montelukast exposure (AUC(0–∞)) was similar in the 1–5-year-old group and the 6–9-year-old group, but 19% lower in the 10–15-year-old group. Among all patients, the total proportion of patients whose global evaluation was “very much better” was 5.7% (week 2), 11.5% (week 4), and 16.9% (week 12) reflecting improvement in symptoms over time. Conclusion: Montelukast was generally well tolerated in Japanese children with PAR. AUC(0–∞)was similar in 1–5 and 6–9-year-olds, while a lower exposure was observed in the 10–15-year-old group likely due to differences in bodyweight. The exposure in Japanese paediatric patients was generally consistent with that in non-Japanese paediatric and adult patients. As assessed by the patients’ caregivers, montelukast also demonstrated symptomatic improvement based on global evaluations of PAR. Taylor & Francis 2016-09-19 /pmc/articles/PMC5040008/ /pubmed/27785374 http://dx.doi.org/10.1080/21556660.2016.1209507 Text en © 2016 Merck & Co., Inc., Kenilworth, N.J., U.S.A. Published by Informa UK Ltd, trading as Taylor & Francis Group. https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits the sharing of the work, in whole or in part, for non commercial purposes, and without derivatives, provided the original work is properly cited. Permission is granted subject to the terms of the License under which the work was published. Please check the License conditions for the work which you wish to reuse. Full and appropriate attribution must be given. This permission does not cover any third party copyrighted material which may appear in the work requested. Merck & Co., Inc., Kenilworth, N.J., U.S.A. reserves the right to redact proprietary information and retains copyright of the protocol on which this article is based. Any further use of the protocol, including these critical sections, will require our permission. Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033 U.S.A.
spellingShingle Original Article
Okubo, Kimihiro
Inoue, Yoichi
Numaguchi, Hirotaka
Tanaka, Kumi
Saito, Itori
Oshima, Nobuyuki
Matsumoto, Yuki
Prohn, Marita
Mehta, Anish
Nishida, Chisato
Philip, George
Montelukast in the treatment of perennial allergic rhinitis in paediatric Japanese patients; an open-label clinical trial
title Montelukast in the treatment of perennial allergic rhinitis in paediatric Japanese patients; an open-label clinical trial
title_full Montelukast in the treatment of perennial allergic rhinitis in paediatric Japanese patients; an open-label clinical trial
title_fullStr Montelukast in the treatment of perennial allergic rhinitis in paediatric Japanese patients; an open-label clinical trial
title_full_unstemmed Montelukast in the treatment of perennial allergic rhinitis in paediatric Japanese patients; an open-label clinical trial
title_short Montelukast in the treatment of perennial allergic rhinitis in paediatric Japanese patients; an open-label clinical trial
title_sort montelukast in the treatment of perennial allergic rhinitis in paediatric japanese patients; an open-label clinical trial
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5040008/
https://www.ncbi.nlm.nih.gov/pubmed/27785374
http://dx.doi.org/10.1080/21556660.2016.1209507
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