Effects of montelukast versus inhaled beclomethasone on asthma control and immunoglobulin-E levels in asthmatic children

Afrah A A. Hasan; Zuhair M Al-Musawi; Haidar A N. Abood; Raghdah Maytham Hameed

doi:10.4103/MTSM.MTSM_26_20

ORIGINAL ARTICLE

Year : 2020 | Volume : 4 | Issue : 4 | Page : 112-115

Effects of montelukast versus inhaled beclomethasone on asthma control and immunoglobulin-E levels in asthmatic children

Afrah A A. Hasan¹, Zuhair M Al-Musawi², Haidar A N. Abood³, Raghdah Maytham Hameed⁴
¹ Department of Pediatrics, Kerbala Teaching Hospital for Pediatrics, Kerbala, Iraq
² Department of Pediatrics, University of Kerbala, Kerbala, Iraq
³ Department of Pharmacology, University of Kerbala, Kerbala, Iraq
⁴ Department of Medical Microbiology, University of Kerbala, Kerbala, Iraq

Date of Submission	16-Jul-2020
Date of Acceptance	04-Aug-2020
Date of Web Publication	9-Oct-2020

Correspondence Address:
Miss. Raghdah Maytham Hameed
Department of Medical Microbiology, University of Kerbala, Kerbala
Iraq

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/MTSM.MTSM_26_20

Abstract

Background: Beclomethasone dipropionate inhaler is a corticosteroid medication used as the controller of persistent asthma. Montelukast is a leukotriene receptor antagonist used as the second-line in controlling the symptoms of the asthmatic child. Objective: The objective of this study is to determine the comparison between the effects of beclomethasone dipropionate inhaler and montelukast on the total serum level of immunoglobulin E (IgE) and childhood asthma control test (C-ACT) in asthmatic children. Patients and Methods: A randomized clinical trial was done in Kerbala Teaching Hospital of pediatric from August 2014 to the end of October 2015, 97 patients were collected from asthma outpatient clinic aged 4 to 11 years with mild persistent asthma and randomly divided into beclomethasone group (51 patients) and montelukast group (46 patients), the total serum IgE was done before the initiation of treatment, and another reading was done after 3 months. The score of symptoms control was evaluated by C-ACT after 1 month of treatment, and another evaluation was done 2 months later. Results: There was a significant reduction in total serum IgE level (21% for montelukast group and 27% for beclomethasone group) after 3 months of treatment compared to baseline IgE, and there was significant improvement in childhood C-ACT scores (16% for montelukast group and 24% for beclomethasone group) after 3 months of treatment compared to the 1^st month of treatment. There was a significant improvement in the beclomethasone group compared to the montelukast group after 3 months of treatment. Conclusions: Both beclomethasone and montelukast are effective controllers for asthma symptoms and reducing the total serum IgE level. Beclomethasone is better than montelukast in improving C-ACT scores.

Keywords: Beclomethasone dipropionate, bronchial asthma, montelukast

How to cite this article:
A. Hasan AA, Al-Musawi ZM, N. Abood HA, Hameed RM. Effects of montelukast versus inhaled beclomethasone on asthma control and immunoglobulin-E levels in asthmatic children. Matrix Sci Med 2020;4:112-5

How to cite this URL:
A. Hasan AA, Al-Musawi ZM, N. Abood HA, Hameed RM. Effects of montelukast versus inhaled beclomethasone on asthma control and immunoglobulin-E levels in asthmatic children. Matrix Sci Med [serial online] 2020 [cited 2021 Jan 25];4:112-5. Available from: https://www.matrixscimed.org/text.asp?2020/4/4/112/297635

Introduction

Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role, in particular, mast cells, eosinophils, T-lymphocytes, macrophages, neutrophils, and epithelial cells. In susceptible individuals, this inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning. These episodes are usually associated with widespread, but variable airflow obstruction that is often reversible either spontaneously or with treatment. The inflammation also causes an associated increase in the existing bronchial hyperresponsiveness to a variety of stimuli.^[1]

Chronic airway inflammation is recognized as an important component of the disease in even the most mildly symptomatic patients. The recognition that chronic inflammatory changes begin at the onset of asthma symptoms has resulted in the increasing use of anti-inflammatory therapy.^[2] Inhaled corticosteroids (ICSs) are the most effective controller therapy for asthma in children of all ages. Corticosteroids are the most potent anti-inflammatory drugs currently available for the treatment of asthma.^[3] Leukotriene modifiers include leukotriene receptor antagonists (LTRA) and a 5-lipoxygenase inhibitor that are available as oral controller drugs for the treatment of pediatric asthma.^[4]

Immunoglobulin E (IgE) is involved in allergic inflammation, especially in early-phase response, but it also involved in late-phase allergic response and the development of chronic allergic diseases.^[5] In allergic asthma, total serum IgE level can be used as a biomarker for monitoring response to therapy.^[6] The childhood asthma control test (C-ACT) provides valuable information regarding asthma control and can discriminate children with different control levels of the disease. Several studies used the C-ACT to estimate asthma control in children.^[7] The test was also used by pharmacological studies to evaluate the responses to drug therapy.^[8] These make it necessary to examine the effects of beclomethasone dipropionate inhaler and montelukast on the total serum level of IgE and C-ACT in asthmatic children.

Aim of study

The aim of this study is to determine the comparison between the effects of beclomethasone dipropionate inhaler and montelukast on the total serum level of IgE and C-ACT in asthmatic children.

Ethical approval

The study protocol was approved by the Ethical Committee in the Iraqi Council for Medical Specialization on January 28, 2015, approval number 482. In addition, verbal approval was obtained from the patients and/or their parents before taking the sample.

Patients and Methods

Our study was done in Kerbala Teaching Hospital of Pediatrics from August 1, 2014, to the end of October 2015, and our patients were collected from asthma outpatient clinic of the hospital.

A randomized clinical study was done on 104 patients, seven of them did not complete the study (because of lack of contact), and assessment of asthma severity was done for each patient.

Patients selection

Inclusion criteria

Mild persistent asthmatic patients with age ranged from 4 to 11 years were included in the study.

Exclusion criteria

Patients on controller therapy, patients who received systemic corticosteroids therapy 1 week before this study, and patients with other chronic diseases were excluded from the study.

Study design

Our study included 97 patients randomly allocated into two groups:

Beclomethsone group: This group included 51 patients who received beclomethasone inhaler (500 microgram (mcg)/day) through spacer device according to the age (with or without face mask), we explained to the patients the procedure of using this inhaler with spacer and number of puffs/day, (dose: 250 mcg twice daily)
Montelukast group: This group included 46 patients, montelukast chewable tablet was given at night, the dose for patients <5 years is 4 mg and for patients aged 5 years or more is 5 mg.

Patients assessment and follow-up

Included the following:

IgE assessment: Determination of total serum IgE level was performed by TOSOH AIA-360 Analyzer (an automated immunoassay analyzer) using a ready-made kit (ST AIA-PACK IgE II) for this purpose
C-ACT: Asthma control test consists of 7 questions, 2 part questionnaire, with one part to be completed by the child (four questions referring to the present condition) and the other part to be answered by the parents (three questions referring to the past 4 weeks). An interview was done with each patient and parent separately. It was translated to the Arabic language, and then, the score was calculated for each patient.

Statistical analysis

Data were introduced into the Statistical Package for the Social Sciences (SPSS) software version 21 (Graph Pad Software, San Diego, California, USA) to do statistical analysis. The results were expressed as mean ± standard deviation. Comparisons between two means were performed using the t-test. The Chi-square test was used to compare between two categorical variables. P > 0.05 was considered to indicate nonstatistical significance while statistically significant if P < 0.01.

Results

Ninety-seven patients (their ages between 4 and 11 years) completed the study, 51 patients were received inhaled beclomethasone, and 46 patients received montelukast for 3 months. Seven patients (3 from beclomethasone group and 4 from montelukast group) did not complete the study.

Baseline characteristics for the patients who completed the study show no significant difference in both groups [Table 1].

Table 1: Patients baseline characteristics

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At the beginning of the study, serum levels of total IgE did not differ among the beclomethasone and montelukast groups (P > 0.05), whereas after 3 months of treatment, there was highly significant reduction (P < 0.01) in total serum IgE levels for patients treated with montelukast or inhaled beclomethasone (21% and 27% respectively), compared to baseline levels. There was no significant difference (P > 0.05) in total serum IgE levels between patients in montelukast and beclomethasone groups after treatment [as shown in [Table 2].

Table 2: Effects of treatment with inhaled beclomethasone and montelukast on total serum IgE levels in children with asthma

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At the end of the 1^st month of treatment, there was no significant difference (P > 0.05) in C-ACT scores between patients in montelukast and beclomethasone treatment groups. While, at the end of 3^rd month of treatment, there was a highly significant increase (P < 0.01) in the C-ACT score for patients treated with montelukast and beclomethasone (16% and 24% respectively), compared to score after 1 month. There was a highly significant difference (P < 0.01) in C-ACT between patients in montelukast and beclomethasone groups after treatment [as presented in [Table 3].

Table 3: Effects of treatment with beclomethasone and montelukast on childhood asthma control test scores in children with asthma during the treatment period

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Discussion

Children with persistent asthma are in need of controller therapy, currently ICSs had been widely recommended as the favorable treatment in patients with persistent asthma, including asthmatic children of different ages.^[9] The LTRAs considered as a successful substitute for the management of persistent asthma in children. Montelukast reported to be the first LTRA that approved by the food and drug administration to be used in young children with asthma.^[9]

The IgE is confirmed to play a fundamental role in allergic immune response; hence, the reduction of total and specific IgE level has been attractive goal in the management of allergic diseases.^[10]

The current study aimed to assess the effect of montelukast versus beclomethasone on the total serum IgE level and asthma control test in children aged 4–11 years, the age and gender distribution was not significantly different between both treatment groups (beclomethasone and montelukast) which indicated adequate randomization and assignment of patients to receive the medication.

Regarding the effects of treatment with montelukast and inhaled beclomethasone on the total serum IgE level in asthmatic children, the present study found that both treatments had significantly reduced the levels of total serum IgE compared to its level at baseline. The mean serum level of total IgE was significantly reduced to 27% in beclomethasone group, and significant reduction to 21% in montelukast group. However, despite the reduction was larger with inhaled beclomethasone than montelukast, the differences in the mean total serum IgE level were statistically insignificant between both groups neither at baseline nor after 3 months, these findings indicated that the effect of montelukast on the total serum IgE level was approximate that of inhaled beclomethasone. These findings agreed that reported in previous studies which compared the effect of these two drugs on the total serum IgE level, In an Italian study, Scaparrotta reported that ICSs and montelukast significantly reduced the serum levels of total and specific IgE in asthmatic children aged 5–11 years.^[9] Similar findings were also reported in an Iranian study was conducted by Razi and Mossave who found a significant improvement in the symptoms and reduction in the circulating total and allergen specific IgE level in asthmatic children aged 6–12 years.^[11]

The current study found a significant improvement in the C-ACT scores after 3 months of treatment (16% improvement in montelukast group and 24% improvement in beclomethasone group) compared to the 1^st month of treatment, on the other hand, a statistically significant difference between both groups had been found at 3 months, where the mean C-ACT score was significantly higher in beclomethasone group than in montelukast group [Table 3], In an Egyptian study, Ahmed et al. reported that both inhaled beclomethasone (the dose used was 600 mcg) and montelukast (the dose used was 5 mg) improved asthma symptoms score after 3 and 6 months of treatment and found that inhaled beclomethasone superior to montelukast at this point.^[12]

At another point of our study, there was parallel improvement in asthma control test in the patient who had reduced total serum IgE level after treatment in both groups, this indicates that the treatment which reduce total serum level of IgE would improve asthma control by improvement of IgE allergic reactions as reported in Ahmed et al.^[12]

Conclusions

Both chewable montelukast and inhaled beclomethasone had significantly improved asthma control after 3 months of treatment, and both drugs were effective in reducing the total serum IgE level in asthmatic children
Inhaled beclomethasone at dose of 500 mcg/day was significantly better than montelukast in improving asthma control.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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