Clinical effectiveness and safety of triamcinolone nasal steroid spray vs flunisolide nasal steroid spray in the treatment of seasonal allergic rhinitis


Freidhoff, L.R.; Norman, P.S.; Creticos, P.S.

Journal of Allergy and Clinical Immunology 81(1): 256

1988


351
COMPARISON
OF
INTRANASAL
CROMOLYN
SODIUM
AND
ORAL
TERFENADINE
FOR
ALLERGIC
RHINITIS.
HA
Orgel,
E0
Meltzer,
JP
Kemp,
NK
Ostrom
and
MJ
Welch,
San
Diego,
CA.
Topical
intranasal
cromolyn
sodium
4%
solution
(CS)
and
oral
terfenadine
60
mg
tablets
(TERF)
both
relieve
symptoms
of
allergic
rhinitis
(AR)
with
few
or
no
adverse
effects
but
no
comparison
of
their
relative
efficacy
has
been
reported.
In
this
double-blind,
double-
dummy
study,
79
pts,
ages
12-56
yrs,
with
symptoms
of
AR
were
randomized
to
receive
either
active
CS
1
spray
in
each
nostril
QID
or
active
TERF
BID
along
with
the
appropriate
placebo
spray
or
tablet
for
4
wks
following
a
1
wk
baseline
qualification
period.
Pts'
daily
symptoms
scores
were
reviewed
weekly
and
constituted
the
primary
efficacy
measures;
assigned
scores
were
on
a
0-5
scale.
Changes
in
nasal
cytology,
nasal
ciliary
clearance
and
rhinomanometry
were
also
assessed.
The
presence
of
adverse
effects
and
the
overall
score
of
medication
efficacy
at
the
end
of
each
week
was
recorded.
The
CS
and
TERF
groups
had
comparable
baseline
scores
for
severity
of
AR
symptoms
and
both
treatments
resulted
in
significant
improvement
(p
0.0001)
with
no
statistical
difference
between
them
for
total
symptoms
scores
at
the
end
of
4
wks.
CS
pts
tended
to
demonstrate
efficacy
earlier
and
TERF
pts
noted
greater
improvement
in
reducing
sneezing
(p=.04)
and
duration
of
nasal
itch
(p=.05).
There
were
no
significant
differences
in
nasal
cytology
or
rhinomanometry.
Reports
of
adverse
effects
were
uncommon
and
only
mild
in
severity.
We
conclude
that
both
CS
and
TERF
are
comparably
effective
and
well-accepted
treatments
for
AR.
352
TRIAMCINOLONE
ACETONIDE
(TA)
NASAL
AEROSOL
IN
THE
TREATMENT
OF
SEASONAL
ALLERGIC
RHINITIS
(SAR).
D.
Tinkelman,
M.D.,
Atlanta,
GA;
C.
Falliers,
M.D.,
Denver,
CO;
G.
Gross,
M.D.,
and
A.
Segal,
M.D.,
Dallas,
TX;
L.
Southern,
M.D.,
Princeton,
NJ;
M.
Welch,
M.D.,
San
Diego,
CA;
H.
Yeates,
M.D., Provo,
UT;
J.
Gorder,
M.D.,
and
J.
Garcia,
Ph.D.,
Horsham,
PA.
TA
is
effective
for
the
prophylactic
treat-
ment
of
asthma.
Recently,
the
delivery
system
for
this
preparation
has
been
modified
for
use
in
allergic
rhinitis.
We
studied
TA
vs.
placebo
in
a
4-week
double-blind
parallel
study
in
180
adult
patients
with
symptomatic
seasonal
allergy
Patients
were
randomly
assigned
to
either
placebo
or
TA
25
mcg/nostril,
qid.
Each
patient
kept
a
daily
diary
rating
rhinitis
symptoms.
Both
the
patient
and
the
physician
also
gave
global
evaluations
of
drug
efficacy.
In
168
evaluable
patients,
significant
reductions
were
seen
at
Week
1,
Week
2,
and
overall
in
the
intensity
ratings
for
rhinitis
symptoms
(p(0.001)
and
duration
of
symptoms
in
the
group
given
TA
(p<0.05).
Superiority
to
placebo
was
evident
by
Day
1
and
maintained
to
the
end
of
the
study.
Both
patients
and
physicians
rated
the
TA
as
significantly
more
effective
than
placebo
for
the
duration
of
the
study
(p<0.001).
There
was
a
marked
reduction
in
nasal
smear
eosinophils
in
the
TA
group.
There
was
no
difference
between
groups
in
safety
evaluation
including
no
evi-
dence
of
suppression
of
the
adrenal
axis
and
no
evidence
of
fungal
infection.
TA
in
a
dose
of
25
mcg/nostril,
qid,
is
safe,
well
tolerated,
(
and
effective
in
reducing
symptoms
in
patients
with
SAR.
353
CLINICAL
EFFECTIVENESS
AND
SAFETY
OF
TRIAMCINOLONE
NASAL
STEROID
SPRAY
VS.
FLUNISOLIDE
NASAL
STEROID
SPRAY
IN
THE
TREATMENT
OF
SEASONAL
ALLERGIC
RHINMS.
L.R.
Freidhoff.
M.S..
P.S.
Norman.
M.D..
P.S,
Creticos.
M.D.
Baltimore,
MD.
27
subjects
with
a
typical
history
of
Spring
pollenosis
as
characterized
by
sneezing,
nasal
congestion,
rhinorrhea
and
verified
by
positive
skin
tests
to
grass
pollen
extract
were
entered
into
a
double-blinded,
randomized,
parallel
6
week
study
to
compare
the
effectiveness
of
triamcinolone
(TRM)
nasal
steroid
spray
to
flunisolide
(FN)
nasal
steroid
spray.
The
TRM
(n=13)
and
FN
(n=14)
groups
were
similar
in
their
entry
demographics
of
age,
sex,
years
of
spring
pollenosis
(Sex:TRM:8M/5F,
FN:8M/6F;
age:TRM:med.
33,
FN:med.
34;
symptoms:
TRM:med.
20,
FN:med.
20).
Symptom
Medication
Diary
(SMD)
scores
demonstrated
similar
scores
for
both
the
(TRM)
and
(FN)
groups
during
the
initial
2
weeks
baseline
(non-treated)
period.
(p>.1).
Both
(TRM)
and
(FN)
groups
demonstrated
efficacy
when
baseline
(weeks
1-2)
were
compared
respectively
to
peak
treatment
(weeks
5-6)
for
both
severity
and
duration
of
symptoms
(P
values
follow):
[FN:severity
.001;
duration
.001/IRM:severity.002;
duration
.002].
No
difference
was
noted
between
either
nasal
steroid
preparation
when
analyzed
by
SMD
for
severity
or
duration
of
symptoms
(P
values
follow):
[Duration:
Week
(Wk)
1/2:0.94;
Wk
3/4:
0.24;
Wk
5/6:
0.81;
Wk
3-6:
0.42//
Severity:
Wk
1/2:
0.64;
Wk
3/4:
0.51;
Wk
5/6:
0.73;
Wk
3-6:
0.85].
Analyses
of
blood
cortisol
levels
likewise
showed
no
differences
between
pre
and
treatment
phases
for
either
group.
We
conclude
the
2
nasal
steroid
preparations
are
equally
safe
and
efficacious
by
this
study.
354
DRUG
EFFECTS
ON
ANTIGEN-INDUCED
RELEASE
OF
HMW-NCA
IN
NASAL
SECRETION
FROM
PATIENTS
WITH
ALLERGIC
RHINITIS.
T.Onda,
T.Uekusa,T.Nagakura,Y.Iikura,K.Ohno,
Tokyo,Japan.
High
molecular
weight-neutrophil
chemo-
tactic
activity(HMW-NCA)has
been
detected
in
a
variety
of
allergic
disorders,mainly
on
bronchial
asthma
and
urticaria.We
have
been
attempted
to
determine
whether
HMW-N
CA
is
playing
a
role
in
allergic
rhinitis.
We
have
challenged
7
subjects
with
allergic
rhinitis.The
disc
of
house
dust
mite
allergen
was
placed
on
nasal
membrane
and
nasal
secretion
was
collected
to
mea-
sure
NCA.Then
pretreatment
of
DSCG,Epi-
nephrine
and
beclomethasone
dipropionate
(BD)was
performed
before
challenge.
NCA
was
measured
by
microchemotaxis
chamber(
Neuro
Probe).Molecular
weight
of
NCA
was
determined
by
gelfiltration
using
S-400(
Pharmacia).Nasal
secretions
were
applied
on
the
columns
of
S-400.NCA
of
each
fra-
ction
was
measured.HMW-NCA
was
eluted
as
a
single
peak
with
estimated
molecular
weight
of
600K
daltons.
Pretreatment
of
DSCG
or
Epinephrine
significantly
inhib-
ited
clinical
symptoms
and
release
of
NCA
into
nasal
secretion(PK0.01,P<0.01,
re-
spectively).There
was,however,no
effect
of
topical
administration
of
BD
on
clin-
ical
signs
or
NCA
release
into
nasal
se-
cretion.
These
results
support
a
view
that
HMW-
NCA
is
involved
in
the
pathogenesis
of
allergic
rhinitis.
256