Efficacy and tolerability of basic treatment with montelukast and fluticasone propionate in school-age children with asthma combined with allergic rhinitis
DOI:
https://doi.org/10.15574/SP.2025.1(145).914Keywords:
children, asthma, allergic rhinitis, montelukast, fluticasone propionateAbstract
Conducting post-marketing studies to study the effectiveness and safety of the use of leukotriene antagonists, in particular montelukast, in alternative treatment regimens for children with comorbid asthma remains important for personalized therapy.
Aim - to study the effectiveness and tolerability of basic therapy with the use of montelukast 5 mg and fluticasone propionate 125 mcg in children with comorbid mild asthma and comorbid moderate asthma, combined with mild persistent allergic rhinitis (AR).
Materials and methods. The clinical effectiveness and tolerability of two basic treatment regimens were prospectively analyzed: montelukast 5 mg monotherapy (group I, n=28, patients with mild asthma and RA) and combined use with fluticasone propionate 125 mcg per day (group II, n=20, patients with moderate asthma and mild persistent AR) for 12 weeks in children aged 6-11 years. The controllability of asthma symptoms was assessed using the validated Children's Asthma Control Test (C-AСT) questionnaire, and the symptoms of asthma were assessed using the visual analog scale (VAS).
Results. Basic therapy with the use of montelukast had a positive effect on the controllability of asthma and AR symptoms in the both groups of children, which was evidenced by a probable (p=0.000) increase in the C-AСT test index with a higher score in children of the II group (p=0.006). Against the background of treatment, the total VAS index in children of the groups I and II decreased by 2.8 times. Monitoring of adverse events against the background of treatment in the studied groups of children testified to the good tolerability of the applied treatment regimens. Only 1 (3.6%) child of the group I had minor abdominal pain.
Conclusions. Monotherapy with montelukast and combined use with fluticasone propionate effectively controls the symptoms of mild and moderate asthma combined with mild persistent RA in children, and is well tolerated.
The study was carried out in accordance with the principles of the Declaration of Helsinki. The study protocol was approved by the Committee on bioethics and deontology of these institutions. The informed consent of the children's parents was obtained for the research.
No conflict of interests was declared by the authors.
References
Akin O, Yavuz ST. (2018). Effects of Inhaled Corticosteroids and Montelukast on Growth and BMI in Children with Asthma. ESPE Abstracts. 89: P-P2-278.
Alanazi F, Alruwaili M, Alanazy S, Alenezi M. (2024). Efficacy of montelukast for adenoid hypertrophy in paediatrics: A systematic review and meta-analysis. Clin Otolaryngol. 49(4): 417-428. https://doi.org/10.1111/coa.14169; PMid:38700144
Al-Shamrani A, Alharbi S, Kobeisy S, AlKhater SA et al. (2022). Adverse Drug Reactions (ADRs) of Montelukast in Children. Children (Basel). 9(11): 1783. https://doi.org/10.3390/children9111783; PMid:36421233 PMCid:PMC9688958
Antipkin YG, Umanets TR, Lapshyn VF, Pustovalova OI, Chumachenko NG. (2016). Effectiveness of montelukast use in preschool and school-age children with mild persistent bronchial asthma. Asthma and allergy. 1: 73-77.
Baruah B, Gupta A, Kumar A, Kumar A. (2023). The Role of Montelukast Sodium in Children with Adenoid Hypertrophy - A Comparative Study. Indian J Otolaryngol Head Neck Surg. 75(2): 306-310. https://doi.org/10.1007/s12070-022-03167-1; PMid:37275091 PMCid:PMC10235367
Bousquet J, Schünemann HJ, Togias A, Bachert C et al. (2020). Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence. J Allergy Clin Immunol. 145(1): 70-80.e3. https://doi.org/10.1016/j.jaci.2019.06.049; PMid:31627910
Caimmi D, Baiz N, Tanno LK, Demoly P et al. (2017). Validation of the MASK-rhinitis visual analogue scale on smartphone screens to assess allergic rhinitis control. Clin Exp Allergy. 47(12): 1526-1533. https://doi.org/10.1111/cea.13025; PMid:28886234
Chu F, Kappel N, Akel M, Press VG et al. (2023). Validity of the Childhood Asthma Control Test in diverse populations: A systematic review. Pediatr Pulmonol. 58(5): 1322-1336. https://doi.org/10.1002/ppul.26342; PMid:36718492 PMCid:PMC10121871
Dykewicz MS, Wallace DV, Amrol DJ, Baroody FM et al. (2020). Rhinitis 2020: A practice parameter update. J Allergy Clin Immunol. 146(4): 721-767. https://doi.org/10.1016/j.jaci.2020.07.007; PMid:32707227
GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. (2017). Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 390: 1211-1259. https://doi.org/10.1016/S0140-6736(17)32154-2; PMid:28919117
Global Initiative for Asthma (GINA). (2024). Global Strategy for Asthma Management and Prevention. URL: http://ginasthma.org/.
Hardas A, Singh N, Mohanty A, Sahu SK. (2022). Efficacy of montelukast in preventing seasonal recurrence of vernal keratoconjunctivitis in children. Eye (Lond). 36(5): 978-984. https://doi.org/10.1038/s41433-021-01484-3; PMid:33947979 PMCid:PMC9046287
Ji T, Lu T, Qiu Y, Li X et al. (2021). The efficacy and safety of montelukast in children with obstructive sleep apnea: a systematic review and meta-analysis. Sleep Med. 78: 193-201. https://doi.org/10.1016/j.sleep.2020.11.009; PMid:33465554
Lee M, Boyce JA, Barrett NA. (2025, Jan). Cysteinyl Leukotrienes in Allergic Inflammation. Annu Rev Pathol. 20(1): 115-141. Epub 2025 Jan 2. PMCID: PMC11759657. https://doi.org/10.1146/annurev-pathmechdis-111523-023509; PMid:39374430
Mayoral K, Lizano-Barrantes C, Zamora V, Pont A et al. (2023). Montelukast in paediatric asthma and allergic rhinitis: a systematic review and meta-analysis. Eur Respir Rev. 32(170): 230124. https://doi.org/10.1183/16000617.0124-2023; PMid:37852659 PMCid:PMC10582929
Mayoral K, Lizano-Barrantes C, Zamora V, Pont A, Miret C, Barrufet C et al. (2023). Montelukast in paediatric asthma and allergic rhinitis: a systematic review and meta-analysis. Eur Respir Rev. 32(170): 230124. https://doi.org/10.1183/16000617.0124-2023; PMid:37852659 PMCid:PMC10582929
Naqi SA, Ashfaq AH, Umar MA, Karmani JK, Arshad N. (2021). Clinical outcome of Montelukast Sodium in Children with Adenoid Hypertrophy. Pak J Med Sci. 37(2): 362-366. https://doi.org/10.12669/pjms.37.2.2670
Nur Husna SM, Tan HT, Md Shukri N et al. (2022). Allergic rhinitis: a clinical and pathophysiological overview. Front Med. 9: 874114. https://doi.org/10.3389/fmed.2022.874114; PMid:35463011 PMCid:PMC9021509
Okhotnikova OM. (2016). The effectiveness of the use of an anti-inflammatory drug with anti-leukotriene action - montelukast sodium as a means of control therapy of bronchial asthma and allergic rhinitis in children. Child's Health. 4(72). 19-28.
Open Prescribing. Montelukast (0303020G0). (2020). URL: https://openprescribing.net/chemical/0303020G0/.
Rana P, Roy V. (2015). Generic medicines: issues and relevance for global health. Fundam Clin Pharmacol. 29(6): 529-542. https://doi.org/10.1111/fcp.12155; PMid:26405851
Shirasaki H, Himi T. (2016). Role of Cysteinyl Leukotrienes in Allergic Rhinitis. Adv Otorhinolaryngol. 77: 40-45. https://doi.org/10.1159/000441871; PMid:27115997
Umanets TR, Lapshyn VF, Matveeva SYu, Pustovalova OI. (2016). Efficacy of montelukast in children with allergic rhinitis. Sovremennaya pediatriya. 4(76): 57-61. https://doi.org/10.15574/SP.2016.76.57
Wei Z, Li S. (2023). An efficacy and safety evaluation of montelukast + fluticasone propionate vs. fluticasone propionate in the treatment of cough variant asthma in children: a meta-analysis. BMC Pulm Med. 23(1): 489. https://doi.org/10.1186/s12890-023-02721-z; PMid:38053076 PMCid:PMC10696880
Wise SK, Damask C, Roland LT et al. (2023). International consensus statement on allergy and rhinology: Allergic rhinitis. Int Forum Allergy Rhinol. 13: 293-859. https://doi.org/10.1002/alr.23090; PMid:36878860
Wu Q, Wang L, Wu M, Lin H. (2023). Effect of Montelukast Combined with Budesonide on Inflammatory Response and Pulmonary Function in Children with Cough Variant Asthma: A Meta-analysis. J Coll Physicians Surg Pak. 33(9): 1040-1049. https://doi.org/10.29271/jcpsp.2023.09.1040; PMid:37691368
Yang S, He X, Zhang R. (2024). Clinical efficacy of montelukast sodium combination therapy for cough variant asthma in children: a meta-analysis. Pediatr Pulmonol. 59: 1541-1551. https://doi.org/10.1002/ppul.26960; PMid:38501316
Zuberi FF, Haroon MA, Haseeb A, Khuhawar SM. (2020). Role of Montelukast in Asthma and Allergic rhinitis patients. Pak J Med Sci. 36(7): 1517-1522. https://doi.org/10.12669/pjms.36.7.2657
Downloads
Published
Issue
Section
License
Copyright (c) 2025 Modern pediatrics. Ukraine
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The policy of the Journal “MODERN PEDIATRICS. UKRAINE” is compatible with the vast majority of funders' of open access and self-archiving policies. The journal provides immediate open access route being convinced that everyone – not only scientists - can benefit from research results, and publishes articles exclusively under open access distribution, with a Creative Commons Attribution-Noncommercial 4.0 international license (СС BY-NC).
Authors transfer the copyright to the Journal “MODERN PEDIATRICS. UKRAINE” when the manuscript is accepted for publication. Authors declare that this manuscript has not been published nor is under simultaneous consideration for publication elsewhere. After publication, the articles become freely available on-line to the public.
Readers have the right to use, distribute, and reproduce articles in any medium, provided the articles and the journal are properly cited.
The use of published materials for commercial purposes is strongly prohibited.
