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International Journal of

Int J Pharm Biomed Res 2011, 2(1), 43-47

PHARMACEUTICAL
AND BIOMEDICAL
RESEARCH
ISSN No: 0976-0350

Research article

A comparative pharmacotherapeutic study of inhalers used in the

management of asthma in south west Nigeria
M.K. Omole*, A. Adewumi
Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, University of Ibadan, Ibadan, Nigeria

Received: 11 Feb 2011 / Revised: 16 Feb 2011 / Accepted: 25 Mar 2011 / Online publication: 28 Mar 2011

ABSTRACT
This study was carried out at Oluyoro Catholic Hospital, Oke-Ofa, Ibadan, Nigeria. Retrospective and prospective
studies were carried out to compare the pharmacotherapeutic efficacy of three anti asthmatic inhalers. The retrospective study
involved 120 medical records of asthmatic patients studied. Seventy two (72) (60%) were in-patients while 48 (40%) were
out-patients. Eighty four (84) (70%) patients were on Inhalers with oral anti asthmatic drugs with 9 (10.7%) on Esiflo
Inhaler, 72 (85.7%) on Salbutamol inhaler and 3 (3.6%) were on Beclomethasone inhaler. Prospective study was carried out
with questionnaires administered to 40 asthmatic patients with 100% respondents. 28 (70%) were on oral anti asthmatic
drugs, while 12 (30%) were on inhalers combined with oral anti asthmatic drugs. Eighteen (18) of the 40 respondents
volunteered to participate in the retrospective study involving Salmeterol/Fluticasone, Salbutamol and Beclomethasone
inhalers. After 60 min, those on Esiflo inhaler had highest PEF values of 280L/min followed by those on Becotide inhaler
with PEF value of 240L/min and those on Ventolin with the least PEF value of 220L/min. After 24 h the patient on Esiflo
inhalers used the medication once with PEF increase to 320L/min followed by those on Becotide inhalers who used the
medication twice with PEF increased to 290L/min and patients on Ventolin inhalers used the medication twice with PEF
increased to 280L/min.
Key words: Pharmacotherapy, Asthma, Asthmatic Drugs, Out patient, South west Nigeria.

1. INTRODUCTION
Asthma is defined as chronic inflammatory disorder of
the airway in which many cells and cellular elements play a
role, in particular mast cells, eosinophils, T. lymphocytes,
macrophages, neutrophils and epithelial cells [1]. This
definition emphasizes that asthma is an inflammatory disease
of the airways and not simply a disease of smooth muscle
broncho-constriction as was once thought [2-4].
Asthma severity classifications were revised in 1997 by
the National Asthma Education and Prevention Programme
(NAEPP) of the National Institute of Health (NIH) in the
second expert panel report of the Heart, Lung, and Blood
Institute to include mild intermittent, mild persistent,
moderate persistent and severe persistent asthma [1,4]. A
patients severity classification plays an important role in
*Corresponding Author. Tel: +234 8064646359, Fax: 234 02 8103043
Email: kayodeomole06@yahoo.com

2011 PharmSciDirect Publications. All rights reserved.

determining the most appropriate pharmacotherapeutic

approach and is determined by the symptoms, treatment
requirements, objective measurements of the lung function
and frequency of nocturnal symptoms [1,2,5].
Histologic and morophologic changes occur in the
airways and lungs of a patient with asthma and these include
airway inflammation and epithelial damage as observed in all
degrees of asthma, including newly diagnosed cases. This
leads to airflow obstruction characterized by acute bronchoconstiction, production of excess mucus and airway
remodeling [6-8]. The fundamental problem in asthma
appears to be immunological. Eosinophils and Lymphocytes
play important role in pathogenesis of asthma [9-10]. The
number of Eosinophils present in the peripheral blood,
bronchial mucosa, broncho-alveolar lavage fluid and the
number of mast cells have been correlated with the degree of
bronchial hyper-responsiveness [11-12]. Lymphocytes
coordinate the inflammatory response by producing cytokines
which promote inflammation [9-13]. The goal of therapy is to
provide symptomatic control with normalization of lifestyle

M.K. Omole et al., Int J Pharm Biomed Res 2011, 2(1), 43-47

and to return pulmonary function as close to normal as

possible, prevent recurrent exacerbations of asthma and
minimize the need for emergency department visits or
hospitalization, and most importantly provide optimal
pharmacotherapy with least amount of adverse effects and
drug interaction [1,4,5]. The specific medical treatment
recommended to asthmatic patients depends on the severity
of their illness and the frequency of their symptoms. Specific
treatments for asthma are broadly classified as relievers,
preventers and emergency treatment [4,8].
Symptomatic control of episodes of wheezing and
shortness of breath is generally achieved with inhaled Betaadrenergic agonist such as Salbutamol, Levalbuterol,
Metaprotenol, Salmeterol which are bronchodilators and
inhaled Corticosteroid such as Beclomethasone, Budesonide,
Flunisolide and Fluticasone used to suppress inflammation of
the airway [14]. With the advent of combination products
containing both beta adrenergic agonists and corticosteroid in
a single preparation, treatment of asthma has improved and
well-controlled [15]. The aim of the study is to compare the
effectiveness of Esiflo which contains the combination of
Salmeterol and Fluticasone with Becotide which contains
Beclometasone, a corticosteroid and Ventolin which
contains Salbutamol, a beta adrenergic agonist in the
management of persistent asthma with the goal of providing
and promoting pharmaceutical care.
2. EXPERIMENTAL
120 case notes of asthmatic patients from the medical
record department of the Catholic Hospital Oluyoro, OkeOfa, Ibadan in Nigeria were selected and studied. 72 (60%)
were in-patients while 48 (40%) were out-patients. 50 (70%)
of the in-patients were admitted from the Emergency
Department.
Table 1
Gender and Age distribution of Asthmatic patients
Type
Gender
Male
Female
Total
Age (years)
Below 19
19-40
Below 40
Total

Frequency

Percentage %

73
47
120

60.3
39.7
100

58
48
14
120

48.3
40.0
11.7
100

Table 2
Side effects documented for the asthmatic patients
Side effects
Cough
Wheezing
Breathlessness
Rhonchi
Tinnitus
Upper respiratory tract infection
Other side effects
Total
* Multiple responses

*Frequency
32
37
20
29
27
21
48
214

Percentage %
15
17.3
9.3
13.6
12.6
9.8
22.4
100

44

Questionnaires were administered to 40 out-patients

volunteers in the hospital. The questionnaires were
administered to determine pharmacotherapeutic effectiveness
of the Inhalers the patients was administered to manage their
asthma. 18 (45%) of the 40 respondents consented to
participate in the retrospective study of the anti-asthmatic
Inhalers. Three (3) different anti-asthmatic Inhalers viz.,
Salmeterol Xinafoate 25mcg/Fluticasone Propionate 250mcg
(Esiflo), was administered to 8 (44.4%) patients,
Salbutamol (Ventolin) was administered to 6 (33.3%)
patients,
while
Beclomethasone
(Becotide)
was
administered to 4 (22.2%) patients. Peak flow meter was used
to determine their peak expiratory flow (PEF) before and
after the administration in 5 min, 15 min, 30 min, 60 min and
24 h. The data was analyzed using students t-test with
Microsoft Version 11.0. The Oluyoro Catholic Hospital
authority granted the approval to conduct this study.
3. RESULTS
Among 120 participant in the study 73 (60.3%) were
males 47 (39.7%) were females, 58 (48.3%) were children
below the age of 19. Forty eight (48) (40.0%) were between
19-40 years of age while 14 (11.7%) were above age of 40.
Patients who had wheezing as side effect were 37(17.3%),
followed by cough 32 (15.0%), rhonchi 29 (13.6%), tinnitus
27 (12.6%), upper respiratory tract infection 21 (9.8%)
breathlessness 20 (9.3%) and other side effects accounted for
16 (7.5%). Antibiotics prescribed as concomitant drugs were
Cotrimoxazole 33 (24.3%), Erythromcin 24 (17.6%),
Ciprofloxacin 24 (17.6%) Gentamycin 23 (16.9%)
Amoxicillin/Clavulate 19 (14%) Azithromyin 7 (5.2%) and
Cephalexin 6 (4.4%).
Among 18 of the 40 asthmatics, who volunteered to
participate both in retrospective and prospective studies, 28
(70%) were on oral antiasthmatic drugs while 12 (30%) were
on Inhalers combined with oral anti asthmatic drugs. The 18
responded the same way in 5 min after the administration of
the 3 inhalers, Esiflo, Ventolin and Becotide. After 60
min, patients on Esiflo had highest PEF value. After 24 h,
patients in Esiflo used it once while those on Ventolin
and Becotide used their medications twice.
4. DISCUSSION
The sample population reviewed were 73 (60.3%) males
and 47 (39.7%) females distributed as 58 (48.3%) children
below 19 years, 48 (40.0%) between 19-40 years old and 4
(11.7%) above 40 years (Table 1). They were presented with
cough 32 (15%), wheezing 37 (17.3%), breathlessness 20
(9.3%), rhonchi 29 (13.6%), rhinitus 27 (12.6%), respiratory
tract infection 2 (9.8%) and other side effects 16 (7.5%)
(Table 2). These were treated with prescribed antibiotics
which were Amoxicillin and Clavulate K 19 (14%)
Erythromycin 7 (5.1%), Cephalexin 6 (4.4%) Cotrimoxazole
33 (16.9%) and Cipro floxacin 24 (17.6%) (Table 3). None of

M.K. Omole et al., Int J Pharm Biomed Res 2011, 2(1), 43-47
Table 3
Antibiotics Prescribed as concomitant drugs for Asthmatic patients.
Antibiotics
Amoxicillin/Clavulate K.
Erythromycin
Azithromycin
Cephalexin
Cotrimoxazole
Gentamycin
Cipro floxacin
Total
* Multiple responses

*Frequency
19
24
7
6.
33
23
24
136

Percentage %
14
17.6
5.1
4.4
24.3
16.9
17.6
100

Table 4
Peak Expiratory flow (PEF) of asthmatic patients before the use of inhaler
compared with healthy volunteers
Patients

Healthy volunteers (L/min)

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18

420
450
480
290
420
300
330
370
430
390
320
300
420
400
400
450
320
300

Asthmatic Patients before

the use of inhaler (L/min)
100
60
60
120
80
90
100
80
70
100
60
120
100
80
70
80
130
90

these antibiotics interacted with the prescribed antiasthmatic

drugs [16]. The first line treatments of asthma exacerbation in
the asthmatic patients studied were by the administration of
Hydrocortisone IV and Ammophylline IV. Hydrocortisone
was given with dosage adjusted depending on the severity of
asthma and the age of the patient [17]. Aminophilline was
given slowly over a period of 15 20 min [18]. Other oral
anti asthmatic drugs were thereafter administered as the
patients became stable. Out of the 120 patients whose case
notes were studied, 72 (60%) used inhalers in combination
with oral anti asthmatic drugs, 12 (10%) were placed on
Salmeterol Xinafoate and Fluti-casone Propronate inhaler, 36
(30%) were on Nebulized Salbutamol. Twelve (12) (10%) of
the patients whose conditions were complicated with severe
hypoxia were placed on intranasal oxygen with Nebulized
Sal-butamol and other anti asthmatic drugs.
Prospective study was carried out whereby
questionnaires were administered to 40 asthmatic patients
with 100% respondents. 28 (70%) were on oral anti asthmatic
drugs while 12 (30%) were on inhalers combined with oral
anti asthmatic drugs. 70% who were on oral anti asthmatic
drugs believed that oral anti asthmatic drugs were better than
inhalers. They expressed the fear of getting addicted to
inhalers as well as fear of death in the situation where they
started the inhalers and because of economic reason, they
were unable to continue when there was an acute

45

exacerbation of asthma. These believe indicated the level of

understanding of most of the asthmatic patients. In case the
inhalers were prescribed to these patients they would
definitely not comply with their inhaler medications [19].
The mean time for asthmatic relieve for the 12 (30%)
asthmatic patients on inhalers such as Ventolin, Becotide
and Esiflo was 10 min while the mean time of asthmatic
relieve was 45 min for the 28 (70%) on oral anti asthmatic
drugs. This study confirms the therapeutic efficacy of
inhalers over oral anti asthmatic drugs and the importance of
patients education on the safe use of inhalers in the treatment
of asthma [20]. At each follow-up visit, the patient should
receive patient education on such subjects as adhering to
medication regimens and using an inhaler and peak flow
meter. Teaching patients self-management strategies such as
how to treat exacerbations, when to increase the frequency of
peak flow monitoring and when to contact the physician is
vital to achieving good asthma control. Giving the patient a
written self-management plan can improve both compliance
and satisfaction. The management of asthma pose a great
challenge both to asthmatic patients and the health care
providers, however, recent advances in the understanding of
the pathophysiology, diagnosis and monitoring of asthma has
helped physicians to optimize treatment strategies [21-22].
Contemporary treatment guidelines emphasize an aggressive
approach, with the prompt and liberal use of antiinflammatory medication to achieve long-term control of
inflammatory disease. It is increasingly recognized that
successful asthma treatment requires a commitment from
patients-physicians and the pharmacists. Patients education
empowers asthmatic patients to begin self-management of
their disease [23]. Such shared responsibility will help to
ensure a favorably clinical outcome and an enhanced quality
of life [24]. The use of a long acting -adrenergic agonist and
a corticosteroid in a single preparation greatly enhanced
compliance, as was shown in this study and this will help to
reduce occurrence of acute exacerbations of asthma which is
the main goal of pharmacotherapy [25]. Administering
medication by inhalation allows delivery directly to the site
of action. Inherent to this, is a lower dosage need, less risk of
systemic adverse effects, potential for improved efficacy and
a faster onset of action than with oral administration [26,27].
The eighteen (18) of the 40 respondents volunteered to
participate in the retrospective parmacotherapeutic efficacy
study involving Esiflo inhaler, Ventolin inhaler and
Becotide inhaler. Esiflo inhaler contains salmeterol
xinafoate, a long lasting B-agonist and fluticasone
proprionate,
a
corticosteoid.
Becotide
contains
Beclomethasone, a corticosteroid and Ventolin is a brand of
Salbutamol, a short acting B agonist. Table 4 shows the
PEF reading of the 18 asthmatic patients who volunteered to
use the inhalers before they were administered.
Eight (8) patients volunteered to be to be on Esiflo six
(6) patients volunteered to be on VentolinR while 4 patients
volunteered to be on Becotide. (Table 5) After 24 h, only 3
of the 18 asthmatic patients reported and the PEF values were

M.K. Omole et al., Int J Pharm Biomed Res 2011, 2(1), 43-47

46

Table 5
PEF readings of those on Esiflo 250, Becotide and Ventolin inhalers
Patients
Esiflo
1
2
3
4
5
6
7
8
Becotide
1
2
3
4
Ventolin
1
2
3
4
5
6

Before medication

5 min

15 min

30 min

60 min

100
60
120
80
90
100
80
70

150
140
150
110
120
150
120
120

150
160
160
120
130
180
130
120

200
180
200
170
180
200
160
150

260
280
280
280
270
260
240
250

80
130
90
120

120
150
120
150

180
170
180
150

180
180
180
170

240
220
240
200

100
60
120
100
80
70

100
120
150
140
110
140

120
180
160
160
130
140

140
180
160
180
150
140

220
220
240
220
210
200

24 h

320

290

260
280

Table 6
Comparing the PEF value of the healthy volunteers with PEF of Asthmatic patients
Group
N
Mean
Standard Deviation
Standard Error Mean
18
367.5000
65.76473
14.70544
PEF of healthy volunteers
PEF of Asthmatic patients
18
91.6667
21.21320
5.00000
Further using student t-test for independent samples (two tailed test). Equal variances assumed and at 36 degree of freedom gave a significance of 0.000. The
mean difference calculated was 276.8333 and the standard error difference calculated was 16.22886.

recorded. PEF with Esiflo was 320L/min, Becotide

290L/min and Ventolin 280L/min. (Table 5) The PEF value
of healthy volunteers was compared with the PEF values of
asthmatic volunteers using student t-test at P value 0.05, and
the result showed that there was statistical significant
(P>0.05) difference in their PEF value (Table 6) as the pvalue obtained is lower (0.000) than the assumed p-value of
0.05; Hull hypothesis was therefore rejected, thereby
confirming asthma in those asthmatic volunteers. In
comparison, there was no statistical difference in efficacy of
the 3 inhalers but there was a clinical difference in the
efficacy of the 3 inhalers studied. Esiflo is the only inhaler
of the three that combined two ingredients of salmeterol
xinafoate and corticosteroid. This is an added advantage in
the convenience of carrying two inhalers components in one.
5. CONCLUSIONS
Studies have shown that drugs with anti inflammatory
activity, specifically the inhaled corticosteroid are the
cornerstone of long term daily therapy for persistence
asthma. As monotherapy, the inhaled corticosteroid such as
beclomethasone (Becotide) are more effective than
Cromolyn, Leucotriene modifiers, Medocromil and
Theophylline in addition inhaled corticosteroids are the only
long term controller therapy that has been associated with a
reduce risk of dying from asthma [28]. Esiflo containing
both fluticasone proprionate, a corticosteroid and Salmeterol

Xinafoate, a bronchodialator has synergistic effect that makes

it clinically more effective than either Salbutamol
(Ventolin) and Beclomethasone (Becotide) as established
in this study.
6. ACKNOWLEDGEMENTS
We acknowledge the technical support of the
management of Oluyoro Catholic Hospital oke-offa Ibadan.
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