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Original Article
COMPARATIVE STUDY ON THE EFFICACY OF MOMETASONE AND FLUTICASONE
NASAL SPRAYS FOR TREATMENT OF ALLERGIC RHINITIS
MAHSHID SADAT MIRMOEZZI
1
, MOHAMMAD SHURIDEH YAZDI
2
, OMID GHOLAMI
3*
1
Medical Student at the Faculty of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran,
2
Department of Otolaryngology-Head
and Neck Surgery, Faculty of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran,
3
Department of Physiology and
Pharmacology, Faculty of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran
Email: omidghphd@gmail.com
Received: 31 Oct 2016 Revised and Accepted: 30 Jan 2017
ABSTRACT
Objective: Allergic rhinitis is the most prevalent of allergic diseases in the world. Nasal corticosteroids are the most applicable drugs for the
treatment of allergic rhinitis. In this study, we compared the efficacy of fluticasone propionate (FP) and mometasone furoate (MF) nasal sprays in
the treatment of allergic rhinitis based on total nasal symptom score (TNSS) questionnaire.
Methods: For this study, 75 allergic rhinitis patients based on skin prick test and inclusion criteria were randomly assigned to two groups: FP and
MF groups. FP group received 200 µg dose of FP nasal spray (1 spray/nostril) daily and the MF group received 100 mg dose of MF nasal spray (1
spray/nostril) daily for 8 w. The effects of the two agents were compared based on TNSS questionnaire in 0, 4 and 8 w after the beginning of the
treatment.
Results: Results showed that patients in both groups exhibited significant improvement in their TNSS (P Value<0.001). A detailed TNSS analysis
showed MF to be more effective for relieving all symptoms than FP. The most difference is in decreasing postnasal discharge (PND) symptom.
However, the difference for relieving all symptoms is not significant (P value>0.05).
Conclusion: In conclusion, FP and MF are significantly effective in relieving of allergic rhinitis symptoms. Even though, the difference between the
two is not significant for 8 w therapy.
Keywords: Fluticasone Propionate, Mometaseone Furoate, Allergic Rhinitis, Total Nasal Symptom Score (TNSS) questionnaire
© 2016 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
DOI: http://dx.doi.org/10.22159/ijpps.2 017v9i3.15958
INTRODUCTION
Allergic rhinitis represents a global health problem that affects 10 to
20% of the population [1]. Allergic rhinitis is a type I hyper-
sensitivity reaction to exogenous substances like a plant or animal
allergens. In this type of reaction, the cutaneous, mucosal-cutaneous
or anaphylactic reaction occurs immediately or several minutes
after exposure. Diagnostic criteria of allergic rhinitis are recurrent
chronic nasal symptoms such as congestion, rhinorrhea (often
including postnasal drip), nasal itching, sneezing, and conjunctiva
irritation [2]. Allergic rhinitis causes sleep disturbance, impairs
psychosocial functioning, and reduces life quality [3].
Allergic rhinitis treatment includes allergen avoidance, pharma-
cotherapy, and immunotherapy. Intranasal corticosteroids are
recommended as first-line therapy for patients with moderate-to-
severe Allergic Rhinitis, especially when nasal congestion is a major
component of symptoms [4]. To compare the efficacy and safety
profile of different available Intranasal corticosteroids for the
treatment of Allergic Rhinitis, it is important to understand the
difference in chemical structures, their pharmacokinetic and
pharmacodynamics properties [4].
Chemical structure of fluticasone and mometasone are displayed in
fig. 1. Relative receptor affinity of MF is greater than FP (2244 vs.
1775) [4]. As pharmacokinetic properties, the bioavailability of MF
is more than FP (46% vs. 42%), and Fraction of unbound intranasal
FP in plasma is more than MF (0.1 vs. 0.01) [5]. Based on these
pharmacodynamics/pharmacokinetic properties, we respect to have
a better clinical outcome for MF than FP.
Fig. 1: Structure of mometasone (A) vs. fluticasone (B) [6]
Despite numerous articles about the efficacy of FP and MF nasal
spray exist, there is no research about the comparing of the
efficacy of these two drugs.
Based on these data, comparing the efficacy of FP and MF on
allergic rhinitis symptoms based on TNSS questionnaire is the aim
of this manuscript.
International Journal of Pharmacy and Pharmaceutical Sciences
ISSN- 0975-1491 Vol 9, Issue 3, 2017
Gholami et al.
Int J Pharm Pharm Sci, Vol 9, Issue 3, 211-214
212
MATERIALS AND METHODS
Participants
This study was conducted in the Division of Otolaryngology, Head
and Neck Surgery at Vasei Medical University Hospital, Sabzevar,
Iran, between August 2015 and March 2016. The study was
approved by the vice chancellor for research of Sabzevar University
of Medical Sciences and Iranian Registry for Clinical Trials
(IRCT2016031419240N2), and written consent was obtained prior
to commencement. The study did not receive the MF and FP
Corporate Support Grant.
The inclusion criteria were: 1) persistent of Allergic Rhinitis
(defined based on clinical examination and verified questionnaire)
2) a positive reaction confirmed by a skin-prick test response. In
positive skin-prick test responses, the skin becomes red and swollen
with a wheal>3 mm in diameter.
The exclusion criteria were: 1) infection in the 2 w preceding the
initial visit; 2) upper and lower respiratory tract infection within 2 w
prior to the study; 3) medication consumption that may affect
allergy symptoms (such as oral antihistamines, decongestants,
steroids, or leukotriene antagonists) within 2 w prior to the study or
during the study period; 4) intranasal corticosteroid use within 2 w
prior to the study; and 5) nasal polyp disease.
In total, 75 patients with allergic rhinitis met the inclusion criteria
for this study.
Study design
In the initial screening visit, comprehensive medical and allergy
histories were obtained for all participants. Daily-activity diaries
were provided to the participants, with instructions to record all
symptoms once treatment began. The diaries of patient activity for
the preceding 7 d were also reviewed.
The study design was randomised, prospective, single-blind and
controlled. The participants were randomly divided into two groups
each participant received a unique code. Of the 75 participants, 6
cases were excluded during the study (2 cases from FP group and 4
cases from MF group), 36 cases received FP nasal spray (FP group),
and 33 cases received MF nasal spray (MF group). FP group received
a 200 µg dose of FP nasal spray (1 spray/nostril) daily for 8 w, and
the remaining participants (MF group) received a 100 µg dose of MF
nasal spray (1 spray/nostril) daily for 8 w.
Total nasal symptom score (TNSS)
Rhinitis symptoms were measured using a 4-point scale. Scores as
follows: 0 denoted “none” (no noticeable symptoms); 1 denoted
“mild” (symptoms are noticeable but not bothersome); 2 denoted
“moderate” (symptoms are noticeable and occasionally bothersome
but do not disturb daily activities and sleep); and 3 denoted “severe”
(symptoms are generally bothersome and disturb daily activities
and sleep). The examiner recorded the patient scores for six nasal
symptoms (nasal congestion, rhinorrhea, postnasal drip (PND),
nasal itching, smelling disorder and sneezing). Baseline TNSS and
each symptom score were calculated as the mean of the scores after
0, 4 and 8 w of initiation of treatment [7].
Statistics
Statistical analysis was performed using IBM SPSS statistics
software. All data are expressed as mean±standard deviation. An
independent sample t-test was used to compare the improvement
rates of the mean TNSS for the two groups. A p value<0.05 was
considered statistically significant. A paired t-test was used to
compare the improvement rates of the mean TNSS for each group
from w0 to w4 and w8. A p value<0.001 was considered statistically
significant.
RESULTS
A total of 75 patients were enrolled in this study, with 36 patients
assigned to an FP group and 33 patients assigned to an MF group.
However, 6 patients with incomplete TNSS recordings during the
treatment period were subsequently excluded from this study. The
mean age of the patients was 21.46 (9.624) years (for FP group) and
20.136 (9.198) years (for MF group). No significant differences were
observed between the two groups for baseline demographics or
health characteristics (table 1).
Table 1: Demography of characteristics and baseline data of the both fluticasone propionate (FP) and mometasone furoate (MF) groups
Variables
FP group
MF group
Number
36
33
Gender
Male
17 (47.2%)
16 (48.5
%)
Female
19 (52.8%)
17 (51.5%)
Age (y)
21.46 (9.624)
20.136 (9.198)
Data are presented as n (%) or mean (standard deviation)
Fig. 2: Mean value of total nasal symptom score (TNSS) in W0,
W4 and W8 (**p<0.001)
For both the FP and MF groups, we analyzed the change in TNSS
from baseline (W 0) to Ws 4 and 8 of the treatment. The TNSS was
the sum of the six nasal symptom scores. No statistically significant
differences were observed between the two groups for baseline
(W0) TNSS scores (Baseline TNSS scores for FP group is 11.46 and
for MF group is 12.18).
The FP and MF groups experienced improvement in allergic rhinitis
nasal symptoms, with symptom improvements of nasal congestion,
rhinorrhea, PND, nasal itching, smelling disorder and sneezing
achieving statistical significance (p value<0.001) from w0 to w4 and
from w0 to w8. Improvement in nasal symptoms for MF group was
better than FP group, but this difference was not significant (p
value<0.05) (fig. 2 and table 2).
DISCUSSION
We found MF sprays to be more effective than FP sprays for
relieving nasal symptoms, as evidenced by the differences in TNSS
between the two groups. But this difference was not significant (p-
value ≤0.05). Some studies found that FP and MF are effective and
safe in allergic rhinitis [8-17]. Some of their results are consistent
with our results, and some of them are not.
Mandl et al. indicated that Mometasone furoate and fluticasone
propionate adequately controlled symptoms of perennial rhinitis
Gholami et al.
Int J Pharm Pharm Sci, Vol 9, Issue 3, 211-214
213
and were well tolerated [8]. Their results are in harmony with our
results. In a recent study, Yonezaki et al. found that fluticasone furoate
was significantly preferred over mometasone furoate in allergic
rhinitis [16]. Their results are not consistent with our results.
In another study, researchers found that following the 4-w therapy,
mometasone furoate (MF) nasal spray provided greater improvement
compared to fluticasone propionate (FP) nasal spray for symptoms
of childhood perennial allergic rhinitis.
Based on their Total Symptom Scores (TS Ss) questionnaire, the
MF group experienced more effecti ve relief of nasal symptoms,
where as the FP group experienced more effective relief of non-
nasal sym ptoms [2].
Table 2: Changes in total nasal symptom score from baseline (W 0) of individual symptoms
Fluticasone propionate group
Mometasone furoate group
Nasal Symptoms
Nasal
congestion
W0
-
W4
-
1.385 (0.815)
-
1.821 (0.548)
W0
-
W8
-
1.821 (0.79)
-
2.321 (0.67)
W4
-
W8
-
0.436 (0.502)
-
0.5 (0.509)
Rhinorrhea
W0
-
W4
-
1.513 (0.854)
-
1.679 (0.67)
W0
-
W8
-
1.795 (0.695)
-
1.964 (0.508)
W4
-
W8
-
0.282 (0.456)
-
0.286 (0.46)
PND
W0
-
W4
-
0.897 (0.598)
-
1.286 (0.6)
W0
-
W8
-
1.051 (0.605)
-
1.357 (0.559)
W4
-
W8
-
0.154 (0.366)
-
0.071 (0.262)
Nasal
itching
W0
-
W4
-
1.487 (0.823)
-
1.714 (0.713)
W0
-
W8
-
1.59 (0.818)
-
1.893 (0.786)
W4
-
W8
-
0.103 (0.307)
-
0.179 (0.39)
Smelling
disorder
W0
-
W4
-
1
.128 (0.656)
-
1.357 (0.731)
W0
-
W8
-
1.538 (0.822)
-
1.643 (0.911)
W4
-
W8
-
0.41 (0.549)
-
0.286 (0.46)
Sneezing
W0
-
W4
-
1.41 (0.85)
-
1.393 (0.685)
W0
-
W8
-
1.538 (0.822)
-
1.464 (0.744)
W4
-
W8
-
0.128 (0.339)
-
0.071 (0.262)
Data are presented as means±standard deviation
This study was subject to several limitations. First, recall bias
contributed to the inconsistent TNSS results. It is better to employ
various examinations, such as nasal peak expiratory flow rate
(nPEFR) and the eosinophil percentage in nasal smears, to reduce
questionnaire bias. Second, we did not classify the severity of
patients’ allergic rhinitis in this study; otherwise, the possible
response differences to treatment for mild persistent, severe-
intermittent, or severe persistent types of allergic rhinitis could have
been analyzed. At last, we lacked patient data on family member
smoking habits and household pets, which are factors that may
affect allergic rhinitis symptoms [9].
CONCLUSION
Our study results show that both intranasal corticosteroid sprays
(FP and MF) were effective for managing allergic rhinitis. FP and
MF treatment were associated with a significant improvement in
mean TNSS (P value<0.001). A further detailed analysis of TNSS
indicated that MF was more effective than FP for relieving nasal
symptoms (except sneezing, table 2), but this difference was not
significant.
In conclusion, the results of our 8-w treatment program showed
that FP and MF nasal sprays were effective for improving the
symptoms of allergic rhinitis significantly. Although the TNSS for
the FP and MF group did not show a significant difference between
them.
ACKNOWLEDGMENT
This study is part of Mahshid Sadat Mirmoezzi M. D. thesis titled:
“Comparison of Mometasone Furoate and Fluticasone Propionate Nasal
Sprays in the Treatment of Allergic Rhinitis”, which has been conducted
in the faculty of medicine, Sabzevar University of Medical Sciences.
This Research Project was fully sponsored by Vice Chancellor for
Research of Sabzevar University of Medical Sciences with grant
number “393010173”. The study did not receive the MF and FP
Corporate Support Grant.
The funding organization is a public institution and had no role in
the design and conduct of the study; collection, management, and
analysis of the data; or preparation, review, and approval of the
manuscript.
CONFLICTS OF INTERESTS
We certify that no actual or potential conflict of interest in relation
to this article exists.
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How to cite this article
• Mahshid Sadat Mirmoezzi, Mohammad Shurideh Yazdi, Omid
Gholami. Comparative study on the efficacy of mometasone and
fluticasone
nasal sprays for treatment of allergic rhinitis. Int J Pharm
Pharm Sci 2017;9(3):211-214.
