Digital Journal of Clinical Medicine

Volume 6 Issue 2 Article 5

2024

To Compare the Efficacy of Oral Deflazacort, Oral Prednisolone

and Inhaled Budesonide in the Treatment of Salbutamol
Refractory Acute Asthma in Children
Santosh Kondekar
TNMC and BYL Nair Hospital Mumbai, [email protected]

Unmesh Dev M
TNMC and BYL Nair Hospital, Mumbai, [email protected]

Surbhi Rathi
TNMC and BYL Nair Hospital Mumbai, [email protected]

Gulrej N. Shaikh
TNMC and BYL Nair Hospital, Mumbai, [email protected]

Corresponding Author:
Dr. Unmesh Dev M
[email protected]

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Recommended Citation
Kondekar S, M UD, Rathi S, Shaikh GN. To Compare the Efficacy of Oral Deflazacort, Oral Prednisolone and
Inhaled Budesonide in the Treatment of Salbutamol Refractory Acute Asthma in Children. Digital Journal
of Clinical Medicine. 2024; 6(2): -. doi: https://doi.org/10.55691/2582-3868.1174

This Original Research is brought to you for free and open access by Research Connect. It has been accepted for
inclusion in Digital Journal of Clinical Medicine by an authorized editor of Research Connect.
To Compare the Efficacy of Oral Deflazacort, Oral Prednisolone and Inhaled
Budesonide in the Treatment of Salbutamol Refractory Acute Asthma in Children

Abstract
Abstract

Background: A 22-month open-label randomized comparative study was conducted at tertiary care centre
attached to medical college in metropolitan city in Maharashtra from Dec 2011 to Oct 2013, aiming to
compare the effectiveness of three corticosteroid treatments - oral deflazacort, oral prednisolone, and
inhaled budesonide in managing salbutamol-refractory asthma in children aged 1-14 years.

Methods: 90 afebrile children were equally allocated to the different treatment arms. Treatment arm A
received oral Deflazacort (1mg/kg/day alternate day), treatment arm B received oral prednisolone (1mg/
kg/day), and treatment arm C received budesonide inhaler (100 mcg/puff twice a day) for seven days,
along with salbutamol inhalations twice a day. The primary outcome measured was the change in FEV1
and PEFR as a percentage of the predicted value from baseline, and secondary outcomes included
changes in FVC, wheeze frequency, VCD, and FEV1/FVC.

Results: Wheeze varied across treatment arms on day 3 (A: 16.3%, B: 26.7%, C: 70.0%), day 7 (A: 10.0%, B:
0.0%, C: 10.0%), and day 28 (A: 16.7%, B: 0.0%, C: 16.7%). Mean PEFR values on days 1, 3, 7, and 28 were
140.67, 180, 202.67, 216.67 for Treatment Arm A; 141.43, 190, 203, 221 for Treatment Arm B; and 151.00,
179.33, 187.33, 202.00 for Treatment Arm C, respectively. FEV1 and FEV1/FVC scores showed no
significant differences across the three treatment arms.

Conclusion: In treating salbutamol-refractory asthma in children, all three medications displayed

comparable efficacy, aiding clinicians in treatment selection and improving outcomes. Future research
should prioritize long-term effects and safety for optimal management.

Keywords
Asthma, Deflazacort, Prednisolone, Budesonide, Salbutamol

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iss2/5
 Kondekar et al.: To Compare the Efficacy of Oral Deflazacort, Oral Prednisolone an

Introduction

According to the World Health Organisation (WHO), one hundred million individuals

suffer from asthma worldwide. Asthma is the most prevalent chronic condition among children.

It is a global health concern, affecting several countries. Several studies in India have reported

varying prevalence rates, ranging from 3.5% to 29.5%1. Asthma often goes undiagnosed and

under treated, burdening individuals and families and potentially limiting their lifelong

activities1. Bronchial Asthma is increasingly prevalent among children in India, with rates

rising faster than previously understood. The rising rate of asthma can be attributed to a

combination of environmental, genetic and lifestyle factors. Increased exposure to air pollution,

allergens, tobacco smoke and occupational hazards can trigger and exacerbate asthma2,3. An

acute asthma exacerbation is characterised by coughing, wheezing (especially at night or early

morning), breathlessness, or chest tightness4.

Asthma-related morbidity and mortality rates are rising despite the advanced

understanding of its pathophysiology and treatment. The primary drug therapy for acute asthma

exacerbation involves bronchodilators and steroids. The choice and dosage of drugs depend

largely on the severity of the attack. Mild acute attacks typically respond well to bronchodilator

therapy. When wheezing persists after three consecutive nebulisation, it is considered

Salbutamol refractory acute asthma (SRAA), potentially leading to respiratory failure5.

Numerous studies have shown that steroid use in acute asthma treatment reduces symptom

duration, hospitalisations, re-consultations, and exacerbations 6,7.

In India, where many patients come from a poor socioeconomic background and cannot

afford inhaled steroids, systemic prednisolone is recommended for acute exacerbations and

moderate asthma not controlled with SABA (Short-Acting Beta-Agonist). Various studies have

compared different steroid molecules and their administration modes in adults and children.

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For instance, oral prednisone has shown greater efficacy in severe acute asthma in children,

while high-dose inhaled Budesonide has proven equally effective as oral corticosteroids in

severe adult asthma8,9. Deflazacort, a derivative of prednisolone with a better safety profile and

fewer effects on glucose and bone metabolism, is well absorbed when administered orally10,11.

Inhaled Budesonide reduces airway inflammation, improving lung function and alleviating

asthma and COPD symptoms. Side effects include minor throat irritation and, rarely, systemic

effects with high, prolonged use 12,13.

Objectives

The aim of the study is to compare the efficacy of three corticosteroid treatments - oral

prednisolone, oral deflazacort, and inhaled budesonide in Indian children with salbutamol-

refractory asthma (SRAA), aged between 1 to 14 years. The rationale for this study is rooted

in the necessity to optimise the management of SRAA in paediatric patients, aiming to improve

outcomes and enhance their quality of life.

Materials and Methods

Patient Population: The study was conducted at a tertiary care centre attached to a medical

college in a metropolitan city in Maharashtra from Dec 2011 to Oct 2013, focusing on afebrile

children aged 1-14 exhibiting wheezing and unresponsiveness to three consecutive inhalations

of salbutamol. Exclusions encompassed those with recent systemic corticosteroid use, specific

medical conditions such as diabetes, tuberculosis, bronchopulmonary dysplasia, cystic fibrosis,

kidney or liver disease, congenital heart disease, shingles, chickenpox, psychopathological

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disorders, fungal infections, severe acute asthma, recent respiratory issues and uncooperative

parents.

Sample Size: A sample size of 90 was taken up by purposive sampling, considering a

prevalence of asthma of 6.3 % in central India14.

Study Design: An open-labelled, randomised, controlled study was conducted over 22 months.

The study was initiated after approval from the institutional ethics committee. Patients who

presented with wheezing and were unresponsive to three consecutive inhalations of salbutamol,

not on any chronic asthma medications, were selected for the study. They were divided into

two groups: <6 years and 6 years or older. Using computerised stratified block randomisation,

children were then randomised into one of the three treatment arms. Treatment arm A patients

received oral deflazacort tablets (1mg/kg/day alternate day), treatment arm B patients received

oral prednisolone tablets (1mg/kg/day), and treatment arm C patients given budesonide inhaler

MDI with spacer (100 mcg/puff twice a day) for 7 days. All the patients received salbutamol

MDI inhalations with spacer twice a day for the same period as per institutional asthma care.

The parents were requested to provide written informed consent.

Outcome Measures: The primary outcome was the change in FEV1 from baseline and PEFR.

Secondary outcomes were the changes in the forced vital capacity (FVC), wheeze frequency,

VCD, and FEV1/FVC. Lung-function measurements were made with a portable spirometer

(MIR Spiro lab III made by MIR via del Maggiolino,12500155 Rome) for children aged above

6 years. The highest value was accepted for analysis. Clinical assessment and patient diary

recordings were used wherever spirometry was not feasible. Recordings were taken on days 1,

3, 7, and 28 days. All patients were given a patient diary and were followed up on days 3, 7,

and 28.

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Data Analysis: Data were analysed using SPSS Software (version 15) and Sigma Plot (version

11). Quantitative data were presented using mean, standard deviation, median, and IQR.

Statistical tests (Kruskal-Wallis or One-way ANOVA) compared study treatment arms.

Qualitative data were shown in frequency and percentage tables, with associations assessed via

the Chi-Square test (p < 0.05).

RESULT

Study Demographics: During the study period, 590 children with acute exacerbations of

asthma were seen, with 240 not responding to salbutamol. Only consenting patients among

these 240 were included in the study. After dropouts 90 children were assigned randomly to

each treatment arm. Treatment arm A had 16 male patients and 14 female patients. Treatment

arm B also had 16 male patients and 14 female patients. Treatment arm C had 14 male patients

and 16 female patients.

Table 1 presents FEV1 values for study treatment arms at days 1, 3, 7, and 28. No

significant differences were noted between treatment arms for FEV1 on these days (p > 0.05)

as per Kruskal-Wallis or one-way ANOVA tests.

Table 1: Comparison of FEV1 on Day 1, 3, 7 & 28 of visit among the study treatment

arms

FEV1 1 N Mean Median Kruskal Wallis Test

Chi-Square P Value
Treatment arm 15 1.17 1.15
A

Treatment arm 14 1.18 1.11 0.073 0.964

B

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Treatment arm 15 1.19 1.15

C

FEV1 3 One way ANOVA test

F value P Value
Treatment arm 15 1.39 1.28
A

Treatment arm 14 1.43 1.40 0.616 0.545

B

Treatment arm 15 1.31 1.22

C

FEV1 7 Kruskal Wallis Test

Chi-Square P Value
Treatment arm 15 1.44 1.49
A

Treatment arm 14 1.50 1.47 1.246 0.536

B

Treatment arm 15 1.43 1.40

C

FEV1 28 Kruskal Wallis Test

Chi-Square P Value
Treatment arm 15 1.51 1.40
A

Treatment arm 14 1.54 1.50 0.409 0.815

B

Treatment arm 15 1.48 1.44

C

Note: Normality Test (Shapiro-Wilk) failed (p < 0.05). Thus, Kruskal Wallis Test was applied.

Table 2 illustrates the PEFR comparison on Days 1, 3, 7, and 28 for the three treatment

arms. One-way ANOVA revealed no significant differences in mean PEFR across treatment

arms on each day (p > 0.05) as per One way ANOVA test.

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Table 2: Comparison of PEFR on Day 1, 3, 7 & 28 of visit among the three treatment

arms

PEFR 1 N Mean Median One way ANOVA test

F value P Value

Treatment arm A 15 140.67 150.00

Treatment arm B 14 141.43 145.00 0.682 0.511

Treatment arm C 15 151.00 150.00

PEFR 3

Treatment arm A 15 180 175

Treatment arm B 14 190.00 200 0.474 0.626

Treatment arm C 15 179.33 180.00

PEFR 7

Treatment arm A 15 202.67 200.00

Treatment arm B 14 203.21 200.00 1.205 0.310

Treatment arm C 15 187.33 180.00

PEFR 28

Treatment arm A 15 216.67 220.00

Treatment arm B 14 221.07 220.00 1.353 0.270

Treatment arm C 15 202.00 190.00

Table 3 shows wheeze frequency in study treatment arms on days1, 3, 7, and 28.

Wheeze was assessed by independent pediatrician managing the asthma OPD. Treatment arm

A significantly reduced from 63.3% on day 3 to 10.0% on day 7, slightly increasing to 16.7%

by day 28. Treatment arm B had no wheeze on days 7 and 28, starting with 26.7% on day 3,

while Treatment arm C demonstrated consistent percentages (70.0%, 10.0%, and 16.7% on day

3, 7, and 28, respectively).

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Table 3: Comparison of a wheeze on day 3, 7 & 28 of visit among the study treatment

arms

Wheeze Wheeze
Wheeze on Day on Day
on Day 3 7 28
Study Treatment Chi- P Df
arm Count Count Count Square Value Value
(%) (%) (%) Value

Treatment arm A 19 3 5 (16.7%) 13.125 0.001* 2

(63.3%) (10.0%)

Treatment arm B 8 (26.7%) 0 (0.0%) 0 (0.0%) 3.214 0.200 2

Treatment arm C 21 3 5 (16.7%) 5.625 0.060 2

(70.0%) (10.0%)

P=<0.05*, significant.

FEV1/FVC ratios were compared on Days 1, 3, 7, and 28 across study treatment arms (Table

4). Day 3 showed a borderline significant difference, but no significant variations were

observed on Days 7 and 28 as per One way ANOVA test or Kruskal Wallis Test.

Table 4: Comparison of FEV1/FVC on Day 1, 3, 7 & 28 of visit among the study treatment

arms

FEV1/ FVC 1 N Mean Median One way ANOVA test

F value P Value

Treatment arm A 15 64.73 62.00

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Treatment arm B 14 65.43 64.50 0.456 0.637

Treatment arm C 15 66.80 66.00

FEV1/ FVC 3 Kruskal Wallis Test

Chi- P Value
Square

Treatment arm A 15 77.20 77.00

Treatment arm B 14 78.71 79.00 5.136 0.077

Treatment arm C 15 73.93 75.00

FEV1/ FVC 7 Kruskal Wallis Test

Chi- P Value
Square

Treatment arm A 15 82.00 82.00

Treatment arm B 14 81.79 83.00 0.879 0.644

Treatment arm C 15 80.53 80.00

FEV1/ FVC 28 Kruskal Wallis Test

Chi- P Value
Square

Treatment arm A 15 83.93 84.00

Treatment arm B 14 83.86 85.00 0.204 0.903

Treatment arm C 15 83.00 85.00

Note: Normality Test (Shapiro-Wilk) failed (p < 0.05). Thus, Kruskal Wallis Test applied.

DISCUSSION

The present study compared the effectiveness of three corticosteroid treatments - oral

deflazacort, oral prednisolone, and inhaled budesonide in managing salbutamol-refractory

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asthma in children aged 1-14 years. The wheeze prevalence, representing a prominent asthma

symptom, differed notably among the different treatment arms on days 1, 3, 7, and 28. This

variation suggests that the treatments had diverse impacts on managing wheezing symptoms at

different stages of the study. It suggests that certain treatments may be more effective in

alleviating wheezing at specific points during the treatment duration.

PEFR, a vital parameter for evaluating airway obstruction, exhibited no significant

differences among the three treatment groups on days 1, 3, 7, and 28. This suggests that the

choice of corticosteroid may not significantly influence immediate airflow improvement in

salbutamol-refractory asthma in children.

FEV1 values, a fundamental measure of lung function, did not differ significantly

among the three treatment arms on days 1, 3, 7, and 28. This implies that all three

corticosteroids had a comparable effect on lung function improvement. The choice of

corticosteroid may not significantly influence immediate lung function improvement in this

context.

FEV1/FVC ratio, an important indicator of airway obstruction, demonstrated no

significant variation among the three treatment arms on days 1, 3, 7, and 28. This indicates that

all three corticosteroids had a similar impact on mitigating airway obstruction. The choice of

corticosteroid may not significantly influence this specific aspect of lung function in this

context.

Our study findings are consistent with the study done by Gartner S, et al. where

researchers compared oral deflazacort and prednisolone for treating moderate asthma in

children aged 6 to 14. Both medications demonstrated comparable efficacy in improving lung

function and alleviating symptoms. No significant differences were found in outcomes or

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adverse effects between the two groups, suggesting both are viable options for managing acute

moderate asthma in paediatric patients9.

A study conducted by Luca Parente et al. showed deflazacort's favourable

pharmacological properties and safety, proposing a unique dose-conversion table comparing it

to other corticosteroids. Deflazacort's flexibility in dosing and safety makes it suitable for

diverse populations. The provided conversion table is a practical tool for clinicians in

prescribing appropriate deflazacort doses15.

A review by Nayak S showed that deflazacort, approved for inflammatory diseases in

several countries, is believed to offer comparable anti-inflammatory efficacy to prednisolone

with potentially milder adverse effects on bone, metabolism, growth, and gastrointestinal

tract16.

The present study sheds light on the best treatment approach for salbutamol refractory

acute asthma in children. The study highlights the importance of using alternative medications

to reduce unnecessary breathing treatments, making the treatment phase easier for children and

their families. Some limitations of the study include the inability of parents to track their child’s

symptoms regularly and describe the symptoms on their child’s behalf, which might be

inaccurate. Also, some families stopped participating in the study, making our results less

certain.

Furthermore, using machines or devices to measure and record symptoms would be

helpful, making the information more accurate and reliable. Additionally, including more

children in the study and following them for a longer period will provide a stronger

understanding of how these medicines work overtime and for different age groups.

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Conclusion

This study provides crucial insights into salbutamol-refractory asthma in paediatric patients.

While the three corticosteroids showed overall comparable effectiveness, variations in

symptom control at different stages emphasise the importance of tailored treatment based on

symptoms and severity. This nuanced approach, considering both lung function and symptom

control, can optimise treatment strategies for paediatric experiencing salbutamol-refractory

acute asthma.

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