Indian Medical Gazette — FEBRUARY 2013 63

Comparative Study

Comparative Efficacy and Outcome Between Metered Dose

Inhaled Corticosteroids and Oral Montelukast in Mild
Persistent Childhood Asthma
Gauranga Biswas, RMO cum Clinical Tutor,
Dept.of Paediatrics, Malda Medical College, Malda.
Erina Saha, RMO cum Clinical Tutor,
Anil Kumar, RMO cum Clinical Tutor,
Prabhabati Banerjee, Professor
— Dept.of Paediatrics, Calcutta Medical College, Kolkata.

Abstract persons of all ages showing increase in prevalence both in

Asthma is a chronic relapsing inflammatory disorder
characterized by hyper reactive airways, leading to episodic,
reversible bronchi constriction, owing to increased
responsiveness of the tracheobronchial tree to various
stimuli1. Specific objectives of the study to compare the
clinical efficacy of oral montelukast with metered dose
inhaled steroids. The results of the study suggests that
metered dose inhaled steroids are superior than oral
montelukast in mild persistent childhood asthma.
Keywords
metered dose steroids, montelukast, childhood asthma
Introduction
Mild persistent asthma is defined as the asthmatic attack
occurs>2/week, but<1/day and>2/month, FEV1 or
PEF>80% of predicted and PEF variability 20-30%.Asthma
is an inflammatory disease, in children it is associated with
allergies2, with generation of IgE in response to external
allergen1, 3. Asthma strongly runs in the family, genes and
environment contribute approximately to the disease4, it is
the most common chronic inflammatory disease that affects
Address for correspondence: Dr Gauranga Biswas, RMO cum Clinical Tutor, Dept.of Paediatrics, Malda Medical College, Malda.
E-mail : biswasgrgkdoc@gmail.com
developed and developing countries.
In this study we tried to compare the clinical efficacy
of oral montelukast with MDI steroids.
Materials and Methods
1. Study area- Asthma clinic, Calcutta Medical College,
Kolkata.
2. Study population- Mild persistent childhood asthma
aged 2-12 years of both sexes diagnosed on the
basis of history, clinical examination, PEF
monitoring and spirometry.
3. Study period- was May 2009 to June 2010.
4. Sample size- 100 cases aged 2-12 years.
5. Sample design- by convenience sampling method.
Inclusion criteria- Children of both sexes with
diagnosed case of mild persistent childhood asthma
once a week in asthma clinic and all cases in
pediatric indoor.
Exlusion criteria- other chronic respiratory illness,
chronic congenital heart disease.
64 Indian Medical Gazette — FEBRUARY 2013

6. Study design- Randomized follow up prospective

parallel group comparative study.

7. Parameters were studied- History, clinical

examination by pulmonary scoring <5years,
spirometry and assessment of FEV1 by
PEF>5years.

8. Study technique- History, clinical examination by

pulmonary scoring system, clinical categorization
of asthma, by PEF monitoring and spirometry,
treatment of study population by two different
drugs therapy and comparative assessment
clinically between two study population.

9. Statistical analysis- Data was analyzed by

appropriate statistical tests like student’ t test, paired
t test and some statistical software like SPSS and
Epi Info etc.

One hundred children aged 2-12 years were enrolled in

the study with 50 children in each group designated as A
for oral montelukast and B for metered dose inhaled steroids
as they met inclusion criteria. Most of the children were
between 2-6years of age.

Results and Analysis

One hundred children were enrolled of which sixty five
(65%) of these 100 children were males and 35% were
females. When two groups were compared according to
age, no significant differences were found.
When two groups were compared according to history
of allergy and family history of allergy in 1st degree
relatives(rhinitis, eczema, urticaria, foods, drugs others)
and known trigger factors no obvious differences were
found as shown in Tables 1 & 2.
When two groups were compared according to base
line and demographic characteristics no significant
differences were observed and all were statistically
insignificant after doing independent sample-t test as shown
in Table 3.
One hundred children were studied over six months
period by 1st visit after 3 months 2nd visit and 3rd visit 3
months after the 2nd visit. Here we compared the patients
of group-A versus group-B between 1st visit and 3rd visit
in our clinic in respect of age and sex distribution and
different variables ie. mPI (modified Pulmonary Index)
score, PEF(Peak Expiratory Flow) variability%, FEV1
(Forced Expiratory Volume in 1 second) or PEF% of
predicted normal.There were significant differences of
secondary variables between group-A & group-B (from
1st visit and 3rd visit ) within each group which was highly
statistically significant by using pared-t test as depicted in
Tables 4 & 5.
Hence in our study, after analyzing all the results, it was
obviously revealed that in mild persistent childhood asthma,
metered inhaled steroids are much superior than the oral
montelukast.
Discussion
Mild persistent asthma is defined as the asthmatic attack
occurs >2/week, but <1/day and >2/month, FEV1 or
PEF>80% of predicted and PEF variability 20-30%.
Indian Medical Gazette — FEBRUARY 2013 65

Recommendations for Treating Mild Persistent Low-dose inhaled corticosteroids Children <5:
Asthma cromolyn, L TRA s (Leukotrienes Receptors Antagonists)

Guideline of Daily Controller Medication Alternative Children >5: cromolyn, L TRA s, nedocromil, sustained
Treatment release theophylline

National Asthma Education and Prevention Program Global Initiative of Asthma (GINA)8
(NAE PP)9 Low-dose inhaled corticosteroids All children: Sustained
66
released theophylline, Cromolyn, L TRA s
British Thoracic Society14
Inhaled steroids All children: L TRA s, theophylline
Our study has attempted to verify the efficacy of
metered dose inhaled steroids in mild persistent asthma and
compare the benefit of oral montelukast among children
with persistent cough, wheezing and respiratory distress
with or without family history of atopy or asthma.So
primarily the study was focusing on proper diagnosis and
categorization of mild persistent asthma and attempts were
made to exclude other chronic respiratory illness and
chronic congenital heart disease.The use of metered dose
inhaled steroids, oral montelukast to treat the child with
mild persistent asthma separately after grouping(A&B) of
the same category patients. Our study was to compare
between two drugs and to assess the outcome. According
to NAEPP9 guidelines controller therapy can be considered
for children who present with frequent exacerbations (at
least two exacerbations occurring <6wk apart).
Inhaled corticosteroids (ICS) therapy is recommended
as preferred therapy for all levels of asthma severity. ICS
are the most potent and effective medications used to
treat the acute and chronic manifestations of asthma.
ICS therapy has been shown to reduce asthma symptoms,
increased lung function. The interest of inhaled steroids
have been significant owing to :
Indian Medical Gazette — FEBRUARY 2013
1. Corticosteroids, decreased airway hyper
responsiveness, decreased “rescue” medication use
and most important decreased urgent care visits
and hospitalization.
2. ICS therapy may lower the risk of death due to
asthma, it can achieve all of the goals of asthma
management and as a result is viewed as the first
line management for persistent asthma.
Leukotriene receptor antagonists (LTRAs) are
considered alternative controllers for mild persistent
asthmatics 7. Montelukast is a potent specific LTRA
administered once daily in tablet form, montelukast reduces
the signs and symptoms of persistent asthma in children
as young as two years of age, with tolerability profile similar
to that of placebo 5,6.GINA8 guideline clearly recommend
the use of LTRAs montelukast as single drug prophylaxis
in mild persistent asthma.This trial was for study to evaluate
the efficacy and out come of montelukast in children with
mild persistent asthma in comparison with long term inhaled
corticosteroids therapy.Analysis of results revealed that the
children in both the groups had similar clinical profile at
the inclusion in the study . After 3rd visit ie. 6 months of
study groups of patients of both metered dose inhaled
steroids and oral montelukast showed significant
improvement in mPI score, PEF variability%, FEV1 or
PEF % of predicted , rescue medications use, emergency
visits, hospitalization and additional medication use.
Indian Medical Gazette — FEBRUARY 2013
However, in the study by Garcia Garcia et al 12.
Significantly better results were observed with ICS
compared to oral montelukast on several secondary
measures including mPI score, PEF variability %, FEV1 or
PEF % predicted.Result from a 12 –weeks study of children
2 to 12 years of age with mild persistent asthma (on the
basis of the requirement for subjects to have a base line
FEV1 >80% of predicted).
Ostrom et al 13 showed significantly better results the
ICS fluticasone (50 micro gram twice daily) than for
montelukast. The results of the current study and other
comparative trials of ICS versus LTRA suggests that ICS
are the most effective single agent controller medication
for pre- school and school- age children with persistent
asthma, even of mild persistent severity. Better outcomes
were observed for inhaled steroids versus oral montelukast
on the rate of asthma exacerbations requiring additional
asthma medications over the changes from baseline in PEF
value and FEV1 and PEF % predicted.
Kerstin Malstrom et al 11 in1999 showed that over the
12-week treatment period, the average change from baseline
in daytime symptom score was 20.62 for beclomethasone,
20.41 for montelukast(P , 0.01 for beclomethasone
compared with montelukast). Each agent improved PEF
and quality of life, reduced nocturnal awakenings and asthma
attacks, increased the number of asthma-control days, and
decreased the number of days with asthma exacerbations
(P, 0.01 for beclomethasone compared with montelukast
for each end point).
In this study by NG DKK et al 10 in 2007, Budesonide
provided significant greater improvement in FEV-1 compared
to montelukast after 4 weeks and 6 weeks of treatment
(p=0.031 and p=0.027 respectively). Montelukast group
had more asthmaexacerbation than the budesonide group
(p=0.0419). Budesonide achieves faster improvement of
FEV-1 and less asthma exacerbation than montelukast.
Yoshihara Shigmi 15 in 2010 suggested that early
intervention with ICS remains most effective medication
for controlling asthma of the currently available drugs for
all ages.
Sobane Patric O et al 16 in 2008 said that ICSs
effectively and reproducibly suppress the inflammatory
process in the airways of most asthmatics.
67
Handerson John et al 17 in 2008 showed that ICSs
are more effective than montelukast incontrolling asthma
in school children with recurrent wheeze.
Oguzulgen I Kilvim et al 18 in 2001 showed that
montelukast can provide a second option in add-on therapy
to ICS in mild persistent childhood asthma.
In conclusion, the results of the current study revealed
that both MDI steroid and montelukast are effective and
well tolerated as long- term controller medications in
children 2 to 12 years of age with mild persistent asthma,
with potentially greater benefits with regard to efficacy and
asthma control for MDI steroid than for oral montelukast.
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