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D Price,1 S Shah,2
S Bhatia,3 C Bachert,4 W Berger,5
J Bousquet,6 W Carr,5 P Hellings,7
U Munzel,8 G Scadding,9 P
Lieberman10 |
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1University of Aberdeen, Aberdeen, UK
2Allergy and Asthma Consultants of NJ-PA,
Collegeville, Pennsylvania, USA
3IRL Clinical Research Centre, Mumbai, India
4Upper Airways Research Laboratory, Ghent
University Hospital, Ghent, Belgium
5Allergy and Asthma Associates of Southern
California, Mission Viejo, California, USA
6Hopital Arnaud de Villeneuve University
Hospital, Montpellier and Inserm CESP1018, France
7University Hospitals Leuven, Leuven, Belgium
8MEDA Pharma GmbH & Co. KG, Bad Homburg,
Germany
9The Royal National Throat Nose and Ear
Hospital, London, UK
10University of Tennessee College of
Medicine, Memphis, Tennessee, USA |
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Abstract |
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Background and
objective:
MP29-02 (Dymista), a
novel intranasal
formulation of
azelastine
hydrochloride (AZE)
and fluticasone
propionate (FP), is
significantly better
than first-line
therapy for the
treatment of
moderate-to-severe
seasonal allergic
rhinitis (SAR), and
is well tolerated
following 52 weeks
of continuous use in
chronic rhinitis.
The aim of this
study was to
evaluate the
long-term efficacy
of MP29-02 versus FP
in patients with
chronic rhinitis.
Patients and
methods: In
total, 612 chronic
rhinitis patients
(perennial allergic
rhinitis [PAR],
n=424; nonallergic
rhinitis, n=188)
aged 12 years or
older were enrolled
into this
open-label,
parallel-group study
and randomized to
MP29-02 (1
spray/nostril bid)
or FP nasal spray (2
sprays/nostril qd)
for 52 weeks.
Efficacy was
assessed by change
from baseline in PM
reflective total
nasal symptom score
(rTNSS), time to
first achieve 100%
PM rTNSS reduction
from baseline, and
percentage of
symptom-free days in
the total and PAR
populations posthoc.
Results:
MP29-02 reduced
patients PM rTNSS
from baseline
significantly more
than FP, from Day 1
up to and including
week 28 (-2.88 vs
-2.53; P=.0048),
with treatment
difference
maintained for 52
weeks. Fluctuation
in significance
after week 28 might
be explained, at
least in part, by
decreasing sample
size, permitted
according to ICH
guidelines. By Day 1
almost twice as many
MP29-02-patients
were symptom free.
After 1 month, 71.1%
of MP29-02 patients
experienced 100%
rTNSS reduction
(60.3% for FP), and
did on a median of 9
days faster (P=.0024).
Over 52 weeks
MP29-02 patients
experienced 8.4%
more symptom-free
days (P=.0005).
These results were
mirrored in the PAR
subpopulation.
Conclusion:
These results
confirm MP29-02s
wide therapeutic
spectrum and assert
its consistent
superiority over an
intranasal
corticosteroid.
Key words:
Dymista. Chronic
rhinitis.
Fluticasone
propionate.
Perennial allergic
rhinitis. Long-term.
Efficacy.
Symptom-free days.
Responder analysis. |
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