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  • Open Access

PD15 - MP29-02 effectively relieves both nasal and ocular symptoms in adolescents aged 12-17 years: results from a meta-analysis of 4 randomised controlled Seasonal Allergic Rhinitis (SAR) trials

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Clinical and Translational Allergy20144 (Suppl 1) :P15

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  • Fluticasone
  • Fluticasone Propionate
  • Seasonal Allergic Rhinitis
  • Ocular Symptom
  • Azelastine


Two large paediatric studies are currently underway in the U.S. to investigate efficacy and safety of MP29-02 (Dymista) in children, with a view to extending its indication to those aged ≥6 yrs. In line with FDA recommendations, these studies compare MP29-02 to placebo. To mimic the clinical trial design of these on-going pediatric studies, this meta-analysis assessed all data available for moderate-to-severe SAR patients aged 12-17 years, who received either MP29-02 or placebo in the same vehicle and device.


Data from 4 multi-centre, parallel-group, randomized, double-blind, placebo-controlled, 14-day studies were pooled. A total of 97 patients aged 12-17 yrs received MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) 1 spray/nostril bid (total daily dose: AZE 548µg; FP 200µg) and 112 patients received placebo spray 1 spray/nostril bid. The primary efficacy variable was change from baseline over 14-days in reflective total nasal symptom score (rTNSS; AM +PM; MAX=24), the sum of 4 symptom scores for congestion, itching, rhinorrhoea and sneezing. Reflective total ocular symptom score (rTOSS; AM + PM; Max = 18) was an important secondary endpoint.


Patients aged 12-17 yrs treated with MP29-02 experienced a 4.29 point mean improvement from baseline (18.7 [SD 2.7]) in their rTNSS, significantly more the 2.06 point improvement from baseline (18.7 [SD 2.8]) observed in those treated with placebo (diff: 2.23; 95% CI: 3.23; 1.22; p<0.0001). Similarly, in this adolescent patient population treatment with MP29-02 produced a significant mean improvement in the rTOSS of 2.23 points from baseline (11.2 [SD 4.4]) compared to 1.04 points from baseline (10.9 [SD 4.0]) with placebo (diff: 1.19; 95% CI: 2.06, 0.32; p=0.0080).


These results show that adolescent SAR patients treated with MP29-02 experience significant relief from both their nasal and ocular symptoms. Similar beneficial effects may be expected in pediatric patients.

Authors’ Affiliations

Suomen Terveystalo Allergy Clinic, Turku, Finland
Medscript, Dundalk, Ireland
Meda, Bad Homburg, Germany
University of Athens, Athens, Greece


© Valovirta et al; licensee BioMed Central Ltd. 2014

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