MP29-02 (a novel intranasal formulation of azelastine hydrochloride and
fluticasone propionate) in the treatment of seasonal allergic rhinitis: a
randomized, double-blind, placebo-controlled trial of efficacy and safety.
Author(s): Meltzer EO, LaForce C, Ratner P, Price D, Ginsberg D, Carr W.
Affiliation(s): Allergy and Asthma Medical Group and Research Center, San Diego, California
92123, USA. EOMELTZER@aol.com
Publication date & source: 2012, Allergy Asthma Proc. , 33(4):324-32
Many patients with allergic rhinitis (AR) have uncontrolled symptoms despite
available treatment options. This study was designed to evaluate the efficacy and
safety of MP29-02 (a novel intranasal formulation of fluticasone propionate [FP]
and azelastine [AZ] hydrochloride), compared with monotherapy with FP, AZ, and
placebo sprays for the treatment of seasonal allergic rhinitis (SAR). This 2-week
randomized, double-blind, placebo-controlled trial was conducted in 779 patients
with moderate-to-severe SAR. Treatments were administered 1 spray/nostril twice
daily in the same vehicle and delivery device. Daily doses of AZ and FP were 548
and 200 micrograms, respectively. The primary efficacy variable was the 12-hour
reflective total nasal symptom score (rTNSS), consisting of nasal congestion,
sneezing, itchy nose, and runny nose. Secondary efficacy variables were (1)
12-hour reflective individual nasal symptom scores; (2) onset of action; (3)
12-hour reflective total ocular symptom score (rTOSS), including itchy eyes,
watery eyes, and red eyes; and (4) the Rhinoconjunctivitis Quality of Life
Questionnaire (RQLQ) overall score. MP29-02 significantly reduced the mean rTNSS
from baseline by -5.54 points compared with FP (-4.55; p = 0.038), AZ (-4.54; p =
0.032), and placebo (-3.03; p < 0.001), improving the rTNSS by 39% beyond the
contribution of FP. All individual nasal symptoms contributed to the efficacy of
MP29-02. Onset of action was within 30 minutes. MP29-02 significantly improved
rTOSS compared with placebo, provided a clinically important improvement in the
overall RQLQ score, and was well tolerated. In this study, MP29-02 provided more
complete symptom relief than two widely used first-line AR treatments and was
well tolerated.
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