mp29-02 and Rhinitis--Allergic--Perennial

Effective pharmacologic treatment exists for most patients suffering from allergic rhinitis (AR). However, both in clinical trials and in real-life studies, many patients are dissatisfied with treatment. Physicians often use multiple therapies, in an attempt to improve symptom control, often with limited evidence of success. Novel treatment options are needed and must consider unmet medical needs.. This article reviews the clinical data for a new AR treatment. MP29-02 (Dymista®, Meda, Solna, Sweden) contains azelastine hydrochloride (AZE) and fluticasone propionate (FP), in a novel formulation and delivered in an improved device as a single nasal spray. It has shown superior efficacy in AR patients than either commercially available AZE or FP monotherapy for both nasal and ocular symptom relief, regardless of disease severity. MP29-02 also provided more effective and rapid symptom relief than either AZE or FP monotherapy delivered in the MP29-02 formulation and device. However, the effect was less than that observed versus commercial comparators, suggesting the impact of formulation and device on clinical efficacy.. MP29-02 simplifies AR management, surpassing the efficacy of gold standard treatment, intranasal corticosteroids (INS), for the first time. It is indicated for the treatment of moderate-to-severe seasonal allergic rhinitis and perennial allergic rhinitis when monotherapy with either intranasal antihistamine or INS is NOT considered sufficient. Most patients present with moderate/severe disease, with evidence of current or previous treatment insufficiency. MP29-02 should be the treatment of choice for these patients.

Topics: Administration, Intranasal; Androstadienes; Anti-Allergic Agents; Drug Combinations; Humans; Phthalazines; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Treatment Outcome

Allergic rhinitis (AR) can be challenging to treat. For many patients, current therapies (including multiple therapies) provide insufficient symptom relief. There is, therefore, a clear unmet medical need for a new and more effective AR treatment option. MP29-02 ( Dymista ) is a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in an advanced delivery system.. The goal of this article is to review all MP29-02 clinical data currently published with a view to establish its potential to fill the current unmet medical need in AR. Relevant articles and abstracts were reviewed from PUBMED and conference proceedings.. MP29-02 represents a breakthrough in AR management for the following reasons: i) MP29-02 has been extensively studied in comparison to first-line therapies in both seasonal AR (SAR) patients and in those with chronic rhinitis (i.e., perennial allergic rhinitis [PAR] and nonallergic (vasomotor) rhinitis) in one of the largest direct head-to-head clinical trial programmes in AR, to date. ii) With MP29-02, the efficacy of an intranasal corticosteroid (INS), the first-line choice for AR has been exceeded for the first time without safety repercussions. AR patients treated with MP29-02 experience significantly greater relief from their overall nasal and ocular symptoms compared to two first-line AR therapies, irrespective of season, symptom type, or disease severity. More patients treated with MP29-02 achieve a substantial reduction (i.e., 50% reduction) in their symptoms and also complete symptom relief and achieve these clinically relevant responses days faster than an INS or antihistamine. iii) Formulation of a topical medication is critical, and MP29-02's novel formulation and/or its device contribute to its clinical efficacy.

Topics: Adrenal Cortex Hormones; Androstadienes; Drug Combinations; Humans; Phthalazines; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Nasal hyperreactivity (NHR) is an important clinical feature of allergic rhinitis (AR). The efficacy of MP29-02 (azelastine hydrochloride (AZE) and fluticasone propionate [FP]) nasal spray on local inflammatory mediators and NHR in AR is unknown. We tested if MP29-02 decreases inflammatory mediators and NHR in AR and if this effect is due to restoration of nasal epithelial barrier function.. A 4-week double-blinded placebo-controlled trial with MP29-02 treatment was conducted in 28 patients with house dust mite (HDM) AR. The presence of NHR was evaluated by measuring reduction in nasal flow upon cold dry air exposure. The effects of AZE ± FP on barrier integrity and airway inflammation were studied in a murine model of HDM-induced NHR and on reduced activation of murine sensory neurons and human mast cells.. MP29-02 but not placebo reduced NHR (P < .0001 vs P = .21), levels of substance P (P = .026 vs P = .941), and β-hexosaminidase (P = .036 vs P = .632) in human nasal secretions. In wild-type C57BL6 mice, the reduction in β-hexosaminidase levels (P < .0001) by AZE + FP treatment upon HDM challenge was found in parallel with a decreased transmucosal passage (P = .0012) and completely reversed eosinophilic inflammation (P = .0013). In vitro, repeated applications of AZE + FP desensitized sensory neurons expressing the transient receptor potential channels TRPA1 and TRPV1. AZE + FP reduced MC degranulation to the same extent as AZE alone.. MP29-02 treatment reduces inflammatory mediators and NHR in AR. The effects of AZE + FP on MC degranulation, nasal epithelial barrier integrity, and TRP channels provide novel insights into the pathophysiology of allergic rhinitis.

Topics: Adult; Androstadienes; Animals; Anti-Allergic Agents; Double-Blind Method; Drug Combinations; Female; Humans; Male; Mast Cells; Mice; Mice, Inbred C57BL; Nasal Mucosa; Phthalazines; Pyroglyphidae; Rhinitis, Allergic, Perennial; Young Adult

MP 29-02, which contains fluticasone propionate and azelastine hydrochloride, is used as a topical nasal application for the treatment of seasonal and perennial allergic rhinitis. Although a multitude of data is available on the clinical symptom reduction and treatment safety of MP 29-02, the effect of MP 29-02 on ciliary beat frequency (CBF) has not been evaluated thus far.. MP 29-02-containing solution was applied at concentrations of 2.5, 5, 10, and 20% to 14 healthy subjects, and nasal ciliated epithelial cells were then visualized using a phase-contrast microscope. CBF was measured after the application of MP 29-02. For a comparison, fluticasone propionate was used. CBF measurements were then performed for 15 min at 22 °C. Ringer's solution was applied as a negative control.. MP 29-02 significantly reduced CBF at all the tested concentrations compared with that of the control group within the observation time. At a 2.5% concentration, MP 29-02 significantly reduced CBF from 6.81 Hz (SD ± 1.35 Hz) at baseline to 4.88 Hz (SD ± 1.52 Hz, p < 0.001) after 15 min. In contrast, for fluticasone propionate, a significant reduction was observed only with the 20% concentration after 5, 10, and 15 min.. MP 29-09 significantly reduced CB, with an almost linear relationship between the MP 29-09 concentration and reduction in CBF. For fluticasone propionate, a significant reduction of CBF was observed only at the highest analyzed concentration. The findings have implications for the long-term use of the MP 29-02. Yet, further clinical studies are needed to confirm these results in vivo, especially in patients with seasonal or perennial allergic rhinits.

Topics: Administration, Intranasal; Adult; Androstadienes; Drug Combinations; Epithelial Cells; Female; Fluticasone; Humans; In Vitro Techniques; Male; Middle Aged; Nasal Mucosa; Phthalazines; Rhinitis, Allergic, Perennial