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13-05-2012 | Internal medicine | Article

Azelastine, fluticasone combination better than existing AR treatments

Abstract

Free abstract

MedWire News: A combined formulation of azelastine and fluticasone propionate (MP29-02) is more effective than current first-line therapies for treating moderate-to-severe allergic rhinitis (AR), show study findings.

Moderate-to-severe AR is a difficult condition to treat, with many patients achieving limited symptom control despite using multiple therapies. "This is the largest body of evidence comparing the efficacy of different types of intranasal AR," say Warner Carr (Allergy and Asthma Associates of Southern California, Mission Viejo, USA) and co-authors.

In total, 3898 patients with a minimum 2-year history of moderate-to-severe AR were enrolled into three multicenter, placebo-controlled trials where they were randomly assigned to active treatment with MP29-02 nasal spray or placebo.

Each trial was conducted over a 14-day period during different allergy seasons, and the primary outcome was the sum of the morning and evening change from baseline in reflective total nasal symptom score (rTNSS; range 0‑24) over the treatment period.

In each study, the combination drug was found to reduce the average rTNSS from baseline significantly more than fluticasone propionate, azelastine, or placebo (average decrease=5.7 vs 5.1, 4.4, and 3.0). Clinical benefit of MP29-02 was observed on the first day (30-minute onset of action) and sustained over the entire course of treatment.

Compared with fluticasone propionate or azelastine monotherapy, patients who received MP29-02 had greater relief from their symptoms of nasal congestion (average decrease=1.3 vs 1.1 and 0.9), nasal itch (1.3 vs 1.2 and 1.0), rhinorrhea (1.4 vs 1.3 and 1.1), and sneezing (1.7 vs 1.5 and 1.3).

In addition, MP29-02 significantly reduced the mean reflective total ocular symptom score (rTOSS) from baseline to a greater extent than fluticasone propionate, azelastine, or placebo (average decrease=3.2 vs 2.8, 2.9, and 1.8).

Further analysis showed that the combination drug controlled symptoms up to 3 days earlier than fluticasone propionate and up to 5 days earlier than azelastine monotherapy. Significantly more patients treated with MP29-02 (12.4%) also exhibited complete or near-complete elimination of their symptoms compared with those treated with fluticasone propionate (9.3%), azelastine (7.1%), or placebo (7.1%).

Finally, the team found that MP29-02 was more effective in patients with more severe disease (baseline TNSS of more than 18.9) than those with less severe disease.

Writing in the Journal of Allergy and Clinical Immunology, the researchers say the results "show that MP29-02 can be considered the drug of choice for AR therapy because it offers additional benefit to patients with AR, in particular with moderate-to-severe disease."

By Ingrid Grasmo

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