Evaluation of fluticasone (flixonase) nasal spray versus beclomethasone (beconase) nasal spray in the treatment of allergic rhinitis


Farid, R.; Farid, F.; Ghaffari, J.; Jabbari, F.; Rahimzadeh, M.

Iranian Journal of Allergy, Asthma, and Immunology 2(4): 193-196

2007


Although response to intranasal steroid therapy has been reported in patients with allergic rhinitis, efficacy of some nasal steroids is noteworthy.This study was undertaken to evaluate the efficacy of a two-week course of Fluticasone (Flixonase) nasal spray vs. Beclomethasone (beconase) nasal spray in patients with symptoms of allergic rhinitis referred to our clinic. This study reviewed sixty randomized studies with symptoms of allergic rhinitis which supported common aeroallergens with skin prick test. Patients received a total daily dose of nasal spray of Fluticasone (Flixonase) 100 mcg bid (N=30) compared with patients with allergic rhinitis who received a total daily dose of Beclomethasone (Beconase) 50mcg 2 puffs bid (N=30). Patients were visited before and after therapy, and efficacy of Flixonase and Beconase was evaluated by the change in nasal symptoms including: nasal discharge, nasal obstruction, nasal itching, and sneezing. After two weeks of treatment nasal symptoms of blockage, discharge, sneezing and itching were significantly better in the group treated with Fluticasone nasal spray (65%, 82%, 67%, 79% respectively (p<0.001) but after treatment with beconase nasal spray lower benefits in the nasal symptoms includes: 50%, 71%, 51%, 57% respectively. After two weeks of treatment no deleterious changes consequent to therapy were observed in nasal symptoms. 100 mcg bid Flixonase (Fluticasone) intranasal spray is more effective than 50 mcg 2 puffs bid Beconase (Beclomethasone) intranasal spray. Like asthma, allergic rhinitis is an inflammatory disease and should be managed with anti-inflammatory medication.

Evaluation
of
Fluticasone
(Flixonase)
Nasal
Spray
Versus
Beclomethasone
(Beconase)
Nasal
Spray
in
the
Treatment
of
Allergic
Rhinitis
Reza
Farid,
Farhad
Farid,
Javad
Ghaffari,
Farahzad
Jabbari,
and
Mahnaz
Rahimzadeh
Bu-Ali
Immunology
Allergy
Center,
Mashhad
University
of
Medical
Sciences,
Mashhad,
Iran
ABSTRACT
Although
response
to
intranasal
steroid
therapy
has
been
reported
in
pa-
tients
with
allergic
rhinitis,
efficacy
of
some
nasal
steroids
is
noteworthy.
This
study
was
undertaken
to
evaluate
the
efficacy
of
a
two-week
course
of
Fluticasone
(Flixonase)
nasal
spray
vs.
Beclomethasone
(beconase)
nasal
spray
in
patients
with
symptoms
of
allergic
rhinitis
referred
to
our
clinic.
This
study
reviewed
sixty
randomized
studies
with
symptoms
of
allergic
rhinitis
which
sup-
ported
common
aeroallergens
with
skin
prick
test.
Patients
received
a
total
daily
dose
of
nasal
spray
of
Fluticasone
(Flixonase)
100
mcg
bid
(N=30)
compared
with
patients
with
allergic
rhinitis
who
received
a
total
daily
dose
of
Beclomethasone
(Beconase)
50mcg
2
puffs
bid
(N=30).
Patients
were
visited
before
and
after
therapy,
and
efficacy
of
Flixonase.
and
Beconase
was
evaluated
by
the
change
in
nasal
symptoms
including:
nasal
discharge,
nasal
obstruction,
nasal
itching,
and
sneezing.
After
two
weeks
of
treatment
nasal
symptoms
of
blockage,
discharge,
sneezing
and
itching
were
significantly
better
in
the
group
treated
with
Fluticasone
nasal
spray
(65%,
82%,
67%,
79%
respectively
(p<0.001)
but
after
treatment
with
beconase
nasal
spray
lower
benefits
in
the
nasal
symptoms
includes:
50%,
71%,
51%,
57%
respectively.
After
two
weeks
of
treatment
no
deleterious
changes
consequent
to
therapy
were
observed
in
nasal
symptoms.
100
mcg
bid
Flixonase
(Fluticasone)
intranasal
spray
is
more
effective
than
50
mcg
2
puffs
bid
Beconase
(Beclomethasone)
intranasal
spray.
Like
asthma,
allergic
rhinitis
is
an
inflammatory
disease
and
should
be
managed
with
anti-in-
flammatory
medication.
Key
words:
Allergic
Rhinitis,
Nasal
Spray,
Treatment.
INTRODUCTION
Allergic
rhinitis
symptoms
include
nasal
conges-
tion,
rhinorrhea,
nasal
itching,
sneezing
and
associ-
ated
symptoms
including
ocular
burning,
ocular
itch-
ing,
sleep
disruption,
fatigue,
headache,
and
restless-
ness
which
promote
irritability
and
impairment
in
con-
Corresponding
Author:
Dr.
Reza
Farid,
Bu-Ali
Immunology,
Allergy
Center,
Mashhad
University
of
Medical
Sciences,
Mashhad,
Iran.
Tel:
(+98
511)
840001-9,
Fax:
(+98
511)
7610681
centration.
2
'
4
'
5
Left
untreated,
allergic
rhinitis
may
pre-
dispose
patients
to
other
respiratory
conditions
such
as
asthma
and
sinusitis.
6
Allergic
rhinitis
is
a
high-cost,
high-prevalence
dis-
ease.
A
one-year
prevalence
is
estimated
at
7.5
to
8.2%
(1)
with
lifetime
prevalence
at
home
more
than
20%
among
the
population
of
the
USA.
In
a
study
in
Lon-
don,
UK,
the
period
prevalence
of
all
forms
of
rhinitis
was
24%.
63%
of
the
cohorts
were
considered
to
have
atopy
with
nasal
obstruction
as
the
most
common
prin-
Vol.
2,
No.
4,
December
2003
IRANIAN
JOURNAL
OF
ALLERGY,
ASTHMA
AND
IMMUNOLOGY
/
193
Fluticasone
in
Allergic
Rhinitis
cipal
symptom.'
In
the
USA
the
cost
of
medication
to
manage
rhini-
tis
for
twelve
months
was
$3.1
billion.
Seventy-seven
percent
of
this
amount
was
spent
on
prescribing
phar-
maceuticals,
for
nonsedating
antihistamines
$1.6
bil-
lion,
and
for
nasal
steroids
$0.8
billion
(Scott-Levin
[Plymouth
Meeting,
Pa]
and
IMS
[Newtown,
Pa]
sales
data,
1997).
Primary
care
9
"
8
and
allergy
textbooks
recommend
antihistamines
as
first-line
therapy.
But
symptoms
are
often
difficult
to
control
with
traditional
rhinitis
pharmacotherapy
(e.g.
antihistamine,
decongestant)
perhaps
because
allergic
rhinitis
is
an
inflammatory
disease
like
asthma
and
the
triggering
agents
are
dif-
ficult
to
avoid.
Also,
symptoms
often
persist
without
any
identifiable
trigger.
7
'
8
If
avoiding
allergens
does
not
result
in
improve-
ment,
antihistamine
therapy
is
a
reasonable
next
step
in
mild
nasal
symptoms.'
If
it
does
not
result
in
im-
provement
with
antihistamine
or
with
moderate/severe
nasal
symptoms,
nasal
corticosteroids
are
recom-
mended.
Malone
et
al
estimated
the
cost
of
treating
patients
with
allergic
rhinitis
at
$0.8
billion
to
$1.48
billion
per
year
for
1994.
10
Loss
of
productivity
due
to
allergic
rhinitis
is
high"
and
this
loss
can
be
decreased
with
effective
nasal
steroids.
Topical
intranasal
glucocorticosteroids
are
very
effective
in
the
treat-
ment
of
patients
with
allergic
and
perennial
rhinitis.
Recently,
a
new
and
potent
corticosteroid,
fluticasone
propionate
aqueos
nasal
spray,
has
become
available
for
treatment
of
allergic
rhinitis.
Systemic
bioavailability
of
fluticasone
nasal
spray
is
extremely
low.
This
data
demonstrates
the
importance
of
study-
ing
this
illness
because
the
efficacy
of
intranasal
flixonase
is
recommended
in
expert
guidelines
as
first-
line
therapy
when
congestion
and
other
symptoms
are
major
components.''''
MATERIALS
AND
METHODS
This
study
was
designed
for
a
single
center,
Dr.
Farid's
Allergic
Clinic.
Out
of
the
patients
referred
to
above
center,
sixty
cases
were
chosen
at
random
with
allergic
rhinitis
symptoms
and
positive
skin
prick
test
of
common
aeroallergens.
Criteria
for
allergic
rhinitis
Table
1.
Thirty
cases
of
allergic
rhinitis.
Advise
fluticason.
Duration
of
Sex
Mean
age
treatment
16
male
37.5
years
14
dayes
14
female
35
years
14
days
Table
2.
Thirty
cases
of
allergic
rhinitis
given
beclomethasone
dipropionate.
Duration
of
Sex
Mean
age
treatment
15
male
35
years
14
days
15
female
33
years
14
days
symptoms
include:
(1)
nasal
blockage,
(2)
nasal
dis-
charge,
(3)
sneezing,
and
(4)
nasal
itching.
After
meet-
ing
the
study
criteria
at
the
screening
(visit
1,
day
1),
we
studied
enrolled
subjects
who
were
randomly
as-
signed
to
one
of
two
treatment
groups:
(1)
100
mcg
bid
Fluticasone
nasal
spray
or
(2)
50
mcg
2
puffs
bid
Beclomethasone
nasal
spray.
Treatment
was
admin-
istered
as
one
spray/nostril
from
each
bottle
twice
daily
in
the
morning
and
at
night.
From
thirty
cases
with
flixonase
nasal
spray
16
males
(54%)
had
a
mean
age
of
37.5
years,
and
14
females
(46%)
had
a
mean
age
of
35
years
(Table
1).
From
the
other
group
in
which
thirty
cases
were
treated
with
beconase
nasal
spray
there
were
15
males
(50%)
with
a
mean
age
of
35
years
and
15
females
(50%)
with
a
mean
age
of
33
years
(Table
2).
On
follow-up
evaluation
visits
after
two-weeks
of
treatment
for
al-
lergic
rhinitis
(AR),
based
on
symptoms
observed
by
the
principal
investigatory
at
the
time
of
visit
and
re-
view
of
the
subjects,
after
two
weeks,
the
subjects'
overall
conditions
of
allergic
rhinitis
were
assessed.
At
each
clinic
visit
nasal
mucosa
was
inspected
with
regard
to
the
grade
of
mucosal
congestion,
secretion,
polyps,
crusting,
bleeding,
and
candidiasis.
The
po-
tency
of
nasal
spray
was
determined.
Duration
of
Flixonase
and
Beconase
treatment
was
two
weeks.
After
treatment
the
patients
were
given
a
questionnaire.
Analysis
showed
that
total
symptoms
including
nasal
blockage,
nasal
discharge,
sneezing,
and
nasal
itching
were
the
main
outcome
parameters
evaluated.
RESULTS
A
total
of
sixty
subjects
with
allergic
rhinitis
were
enrolled
in
the
study,
with
two
immediate
dropouts.
Thirty
subjects
received
100
mcg
bid
fluticasone,
and
thirty
subjects
received
50
mcg
2
puffs
bid
beclomethasone.
In
all
100%
of
patients
completed
the
protocol-specified
fourteen-day
treatment.
Analy-
sis
of
the
primary
efficacy
showed
that
both
flixonase
and
beconase
improved
total
nasal
symptoms.
In
Flixonase
treated
subjects
there
were
55%
males
(n=16)
with
a
mean
age
of
37.5
years,
and
45%
females
194
IRANIAN
JOURNAL
OF
ALLERGY,
ASTHMA
AND
IMMUNOLOGY
Vol.
2,
No.
4,
December 2003
R.
Farid,
et
al.
(n=14)
with
a
mean
age
of
35
years.
In
comparison
Beconase
treated
subjects
were
50%
male
(n=15)
with
a
mean
age
of
35
years,
and
50%
female
(n=15)
with
a
mean
age
of
33
years
(Tables
1,2).
All
patients
were
given
questionnaires
after
two
weeks
of
treatment.
Analysis
of
the
primary
efficacy
for
both
groups
showed
that
fluticasone
and
beclomethasone
nasal
sprays
decreased
total
nasal
symptoms
of
allergic
rhinitis
(Table
3,
figure
3).
Analy-
sis
of
the
secondary
efficacy
showed
fluticasone
na-
sal
spray
to
be
significantly
more
effective
than
beclomethsone
nasal
spray
after
two
weeks'
treatment
(p<0.001).
In
fluticasone
treated
subjects,
nasal
blockage
re-
sponse
was
65%
(n=20)
compared
to
50%
(n=15)
in
beconase
treated
subjects
(p<0.001).
In
flixonase
treated
subjects
nasal
discharge
im-
proved
82%
(9n=25)
compared
with
71%
(n=20
in
beconase
treated
subjects
(p<0.001).
In
flixonase
treated
subjects
sneezing
improved
67%
(n=20)
compared
with
51%
(n=15)
in
beconase
treated
(p<0.001).
In
flixonase
treated
subjects
nasal
itching
im-
proved
79%
(n=24)
compared
with
57%
(n=17)
in
beconase
treated
(p<0.001).
For
all
four
nasal
symptoms
both
active
treatments
demonstrated
efficacy,
but
the
fluticasone
nasal
spray
treatment
group
showed
a
greater
numerical
decrease
in
each
individual
for
nasal
symptoms
as
compared
with
the
beclomethasone
nasal
spray
treatment
group.
DISCUSSION
The
primary
aim
of
this
study
was
to
investigate
the
efficacy
of
flixonase
nasal
spray
itself
and
com-
pare
it
with
beconase
nasal
spray
when
used
for
a
period
of
two
weeks
in
the
treatment
of
allergic
rhini-
tis.
Intranasal
cortico-steroids
are
considered
safe
regarding
their
effect
on
nasal
mucosa
after
short-
and
long-term
use.
This
integrated
analysis
of
data
from
a
randomized
study,
demonstrates
the
superiority
of
fluticasone
(FT)
nasal
spray
in
a
group
of
patients
with
allergic
rhinitis
over
beconase
nasal
spray
in
the
treatment
of
patients
with
allergic
rhinitis.
There
is
a
clinical
impression
that
allergic
rhinitis
symptoms
are
less
responsive
to
nasal
spray
beconase.
The
flixonase
nasal
spray
rec-
ommended
dose
of
100
mcg
bid
for
two
weeks
is
as
effective
as
beconase
nasal
spray
50
mcg
2
puffs
bid
for
two
weeks.
The
results
of
this
integrated
analysis
showed
that
the
allergic
rhinitis
treated
with
nasal
spray
flixonase
at
100
mcg
twice
daily
and
nasal
spray
beconase
50
mcg
2
puffs
twice
daily
noted
reduction
of
nasal
symptoms
during
two
weeks
of
treatment,
ex-
hibiting
statistically
significant
decreases
in
symp-
toms
with
flixonase
compared
with
patients
treated
with
beconase.
The
broad
efficacy
of
fluticasone
for
a
range
of
nasal
symptoms
in
allergic
rhinitis
differenti-
ates
it
from
ipratropium
bromide,
which
has
been
shown
to
improve
rhinorrhea,
but
not
other
nasal
symptoms.'
In
the
current
study,
the
approved
100
mcg
bid
dose
seemed
to
confer
efficacy
in
relieving
nasal
symptoms
comparable
with
that
of
the
50mcg
2
puffs
bid
dose
of
beconase.
Fluticasone
nasal
spray
is
also
an
effective
treat-
ment
for
perennial
non-allergic
rhinitis
with
or
with-
out
nasal
eosinophilia
(nares
or
non-nares).
15
The
lack
of
effect
of
flixonase
nasal
spray
on
growth
in
this
study
distinguishes
it
from
more
bioavailable
intranasal
cortico-steroids
such
as
beconase
budesonide.'
Beconase,
administered
twice
a
day,
causes
a
0.9
cm
reduction
in
height.'
Specifi-
cally,
flixonase
with
very
low
systemic
bioavailability
does
not
suppress
growth
in
long-term
study.
It
has
been
suggested
that
patients
with
severe
symptoms
use
nasal
Flixonase
and
non-sedating
antihistamines
in
combination.
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Rhinitis
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