ASTHMA CONTROL STATUS IN PATIENTS TREATED WITH ADD-ON MONTELUKAST (XYFLO): A REAL-WORLD OBSERVATIONAL STUDY
Main Article Content
Keywords
Asthma, Montelukast, ACT, Leukotriene, Xyflo, Bangladesh
Abstract
Introduction: Asthma remains a major global non-communicable disease affecting approximately 339 million individuals worldwide. Despite pharmacological advances and evidence-based guidelines, population-level asthma control remains suboptimal. Montelukast, a selective cysteinyl leukotriene receptor-1 (CysLT1) antagonist, is approved as add-on controller therapy in patients inadequately controlled on inhaled corticosteroids (ICS) alone. The Asthma Control Test (ACT) is a validated, patient-reported outcome instrument for quantifying real-world disease control.
Aim of the Study: To describe the distribution of ACT-derived asthma control categories and to examine the associations of treatment duration and biological sex with asthma control status in a real-world cohort of patients receiving add-on montelukast (Xyflo).
Methods: A multi-centre, department-based, prospective observational study was conducted over two years across five tertiary and general hospitals in Bangladesh. A total of 875 patients of all age groups (0–82 years) with physician-diagnosed persistent asthma receiving add-on montelukast (Xyflo) were enrolled. The primary outcome measure was ACT total score; secondary analyses examined the association of biological sex and treatment duration with ACT category (uncontrolled ≤15, partially controlled 16–19, well controlled ≥20) using an independent-samples t-test.
Results: Of 875 enrolled patients (mean age 36.79 ± 21.90 years; 58.1% male), the mean ACT total score was 17.80 ± 4.04. Based on ACT categories, 42.4% of patients achieved well-controlled asthma (ACT ≥20), 41.0% were partially controlled (ACT 16–19), and 16.6% remained uncontrolled (ACT ≤15); overall, 83.4% attained at least partial asthma control. The mean duration of montelukast (Xyflo) use was 3.60 ± 10.40 months. Independent-samples t-test revealed no statistically significant difference in mean ACT scores between male and female patients (p = 0.588). Binary logistic regression demonstrated that age (adjusted OR 1.001, 95% CI 0.993–1.009; p = 0.874), sex (adjusted OR 0.904, 95% CI 0.628–1.302; p = 0.588), and duration of montelukast use (adjusted OR 1.004, 95% CI 0.985–1.024; p = 0.656) were not independently associated with achieving asthma control.
Conclusion: Add-on montelukast (Xyflo) was associated with a high rate of asthma control in this real-world Bangladeshi cohort, with 83.4% of patients achieving at least partial ACT-defined control. Sex and treatment duration did not independently predict asthma control outcomes, supporting the broader applicability of leukotriene receptor antagonist therapy across patient subgroups in routine clinical practice.
References
2. Nathan RA, Sorkness CA, Kosinski M, et al. Development of the Asthma Control Test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004;113(1):59–65. doi:10.1016/j.jaci.2003.09.008.
3. Reddel HK, Bateman ED, Becker A, et al. A summary of the new GINA strategy: a roadmap to asthma control. Eur Respir J. 2015;46(3):622–639. doi:10.1183/13993003.00853-2015.
4. Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REALISE survey. NPJ Prim Care Respir Med. 2014;24:14009. doi:10.1038/npjpcrm.2014.9.
5. Peters-Golden M, Henderson WR Jr. Leukotrienes. N Engl J Med. 2007;357(18):1841–1854. doi:10.1056/NEJMra071371.
6. Dahlen SE, Hedqvist P, Hammarstrom S, Samuelsson B. Leukotrienes are potent constrictors of human bronchi. Nature. 1980;288(5790):484–486. doi:10.1038/288484a0.
7. Drazen JM, Israel E, O'Byrne PM. Treatment of asthma with drugs modifying the leukotriene pathway. N Engl J Med. 1999;340(3):197–206. doi:10.1056/NEJM199901213400306.
8. Reiss TF, Chervinsky P, Dockhorn RJ, Shingo S, Seidenberg B, Edwards TB. Montelukast, a once-daily leukotriene receptor antagonist, in the treatment of chronic asthma: a multicentre, randomised, double-blind trial. Arch Intern Med. 1998;158(11):1213–1220. doi:10.1001/archinte.158.11.1213.
9. Joos S, Miksch A, Szecsenyi J, et al. Montelukast as add-on therapy to inhaled corticosteroids in mild-to-moderate asthma: a systematic review. Thorax. 2008;63(5):453–462. doi:10.1136/thx.2007.081596.
10. Cazzola M, Calzetta L, Bettoncelli G, et al. Asthma management in Italy: is the unmet need driven by the disease or by the physician? Respir Med. 2013;107(8):1170–1177. doi:10.1016/j.rmed.2013.04.009.
11. Braman SS. The global burden of asthma. Chest. 2006;130(1 Suppl):4S–12S. doi:10.1378/chest.130.1_suppl.4S.
12. Sultana S, Islam MS, Hossain MA, et al. Prevalence, severity, and determinants of asthma control among adult asthmatic patients attending tertiary care hospitals in Dhaka, Bangladesh. J Asthma. 2019;56(7):724–731. doi:10.1080/02770903.2018.1493602.
13. Partridge MR, van der Molen T, Myrseth SE, Busse WW. Attitudes and actions of asthma patients on regular maintenance therapy: the INSPIRE study. BMC Pulm Med. 2006;6:13. doi:10.1186/1471-2466-6-13.
14. Wenzel SE. Asthma phenotypes: the evolution from clinical to molecular approaches. Nat Med. 2012;18(5):716–725. doi:10.1038/nm.2678.
15. Tantisira KG, Lima J, Sylvia J, Klanderman B, Weiss ST. 5-lipoxygenase pharmacogenetics in asthma: overlap with Cys-leukotriene receptor antagonist loci. Pharmacogenet Genomics. 2009;19(3):244–247. doi:10.1097/FPC.0b013e328325a9c8.
16. Chauhan BF, Ducharme FM. Addition to inhaled corticosteroids of long-acting beta2-agonists versus anti-leukotrienes for chronic asthma. Cochrane Database Syst Rev. 2014;(1):CD003137. doi:10.1002/14651858.CD003137.pub5.
17. Szefler SJ, Phillips BR, Martinez FD, et al. Characterization of within-subject responses to fluticasone and montelukast in childhood asthma. J Allergy Clin Immunol. 2005;115(2):233–242. doi:10.1016/j.jaci.2004.11.014.
18. Liu AH, Zeiger R, Sorkness C, et al. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007;119(4):817–825. doi:10.1016/j.jaci.2006.12.662.
19. Dolan CM, Fraher KE, Bleecker ER, et al. Design and baseline characteristics of the Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study: a large cohort of patients with severe or difficult-to-treat asthma. Ann Allergy Asthma Immunol. 2004;92(1):32–39. doi:10.1016/S1081-1206(10)61707-3.
20. Miranda C, Busacker A, Balzar S, Trudeau J, Wenzel SE. Distinguishing severe asthma phenotypes: role of age at onset and eosinophilic inflammation. J Allergy Clin Immunol. 2004;113(1):101–108. doi:10.1016/j.jaci.2003.10.041.
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All articles published in JPTCP are licensed under Copyright Creative Commons Attribution-NonCommercial 4.0 International License.
Prof. Dr. Shamsul Arefeen Khan
Professor, Department of Respiratory Medicine, Kumudini Women's Medical College & Hospital, Tangail, Bangladesh;
Prof. Dr. Toufiqur Rahman Faruque
Professor, Department of Cardiology, National Institute of Cardiovascular Diseases (NICVD), Dhaka, Bangladesh;
Dr. Mr. Minhaz Uddin Ahmed
Associate Professor, Department of Internal Medicine, Dhaka Medical College & Hospital, Dhaka, Bangladesh;
Dr. Md. Akram Hossain
Associate Professor, Department of Cardiology, 250 Bedded General Hospital, Chattogram, Bangladesh;
Dr. Md. Sanwar Nawaz Khan
Assistant Professor, Department of Respiratory Medicine, 250 Bedded General Hospital, Pabna, Bangladesh;
Dr. Tanni Kundu Tanu
Department of Public Health, North South University, Dhaka, Bangladesh;
Matrika Saha Roy
Department of Pharmacy, Jahangirnagar University, Dhaka, Bangladesh;
Mahin Hossain
Department of Pharmacy, North South University, Dhaka, Bangladesh;
Md. Rakibul Hasan
Department of Pharmacy, North South University, Dhaka, Bangladesh;
