Superior effect of MP-AzeFlu than azelastine or fluticasone propionate alone on reducing inflammatory markers

Roca‐Ferrer, Jordi; Pujols, Laura; Pérez-González, M; Alobid, Isam; Callejas, Borja; Vicens-Artés, Sònia; Fuentes, Mireya; Valero, Antonio; Picado, César; Castor, Dennis; Nguyen, DucTung; Mullol, Joaquim

doi:10.1186/s13223-018-0311-4

Cited by 12 publications

(13 citation statements)

References 55 publications

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“…2,3 MP-AzeFlu has been shown to inhibit eosinophil survival and reduce IL-6 concentrations better than either FP or AZE in a human nasal epithelial cell model, an effect mediated via induction of antiinflammatory gene expression (ie, GILZ & MKP-1). 51,52 This MP-AzeFlu-induced anti-eosinophilic effect was also apparent in the lower airways, evidenced by total abrogation of eosinophils in bronchoalveolar lavage fluid from mice. 53 Further work is necessary to establish if nasally applied AR medications have a systemic antiinflammatory effect.…”

Section: Discussionmentioning

confidence: 93%

Evaluating the real-life effect of MP-AzeFlu on asthma outcomes in patients with allergic rhinitis and asthma in UK primary care

Jong

Voorham

Scadding

et al. 2020

World Allergy Organization Journal

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Background MP-AzeFlu (Dymista®; spray of azelastine/fluticasone propionate) is the most effective allergic rhinitis (AR) treatment available. Its effect on asthma outcomes in patients with AR and asthma is unknown. Methods This pre-post historical cohort study, using the Optimum Patient Care Research Database, included patients aged ≥12 years, from UK general practice with active asthma (defined as a recorded diagnosis, with ≥1 prescription for reliever or controller inhaler) in the year before or at the initiation date. The primary study outcome was change in number of acute respiratory events (i.e. exacerbation or antibiotic course for a respiratory event) between baseline and outcome years. The effect size of MP-AzeFlu was quantified as the difference in % of patients that improved and worsened. Results Of the 1,188 patients with AR and asthma included, many had a record of irreversible obstruction (67%), and uncontrolled asthma (70.4%), despite high mean daily doses of reliever/controller therapy and acute oral corticosteroid use, in the year pre-MP-AzeFlu initiation. MP-AzeFlu initiation was associated with fewer acute respiratory events (effect size (e) = 5.8%, p = 0.0129) and a reduction in daily use of short-acting β 2 -agonists, with fewer patients requiring >2 SABA puffs/week (e = 7.7% p < 0.0001). More patients had well-controlled asthma 1-year post-MP-AzeFlu initiation (e = 4.1%; p = 0.0037), despite a reduction in inhaled corticosteroids (e = 4.8%; p = 0.0078). Conclusions This study provides the first direct evidence of the beneficial effect of MP-AzeFlu on asthma outcomes in co-morbid patients in primary care in the United Kingdom. Trial registration EUPAS30940. Registered August 13, 2019.

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Section: Discussionmentioning

confidence: 93%

Evaluating the real-life effect of MP-AzeFlu on asthma outcomes in patients with allergic rhinitis and asthma in UK primary care

Jong

Voorham

Scadding

et al. 2020

World Allergy Organization Journal

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“…Over-additive effects of MP-AzeFlu has been observed for certain symptoms, most notably nasal congestion. This may be due to the fact that MP-AzeFlu is more than a simple fixed dose combination product, comprising anti-histaminic, mastcell stabilizing, anti-leukotriene and anti-inflammatory properties [3]. MP-AzeFlu is well tolerated by patients both in RCTs and in real life, but a bitter taste (due to azelastine) has been reported, and traditionally classified as an adverse event.…”

Section: To the Editormentioning

confidence: 99%

Effects of MP-AzeFlu enhanced by activation of bitter taste receptor TAS2R

Ekstedt

Georén

Cardell

2020

Allergy Asthma Clin Immunol

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MP-AzeFlu is relatively new a pharmaceutical drug used in the treatment of allergic rhinitis. It is comprised of azelastine hydrochloride (AZE), a potent histamine-H1-receptor antagonist and fluticasone propionate (FP), corticosteroid. It's somewhat bitter taste (often considered a disadvantage) can be attributed to AZE. We here hypothesize that MP-AzeFlu may induce some of its beneficial effects through activation of bitter taste receptors (Tas2R), which have recently been described in human airways. In the nose Tas2Rs induce secretion of antimicrobial peptides and increase ciliary activity, while in the lung they cause airway smooth muscle relaxation. The mechanisms behind Tas2R-mediated effects are not yet fully known. In order to evaluate the role of Tas2R in the effects induced by MP-AzeFlu the dilatory response of pre-contracted isolated airways from Balb/c mice was investigated in tissue bath myographs in the presence or absence of various well-characterized pharmacological antagonists or their corresponding vehicles. MP-AzeFlu caused a potent dose-dependent relaxation of pre-contracted airways, an effect probably mediated by its AZE component. The dilatory effect of MP-AzeFlu and AZE both mimicked the response induced by the Tas2R agonist, chloroquine, but was independent of histamine receptor (H1-, H2-and H3-), prostaglandins, cAMP and cGMP involvement, all known to be common pathways for airway dilation. Other bitter-tasting antihistamines (i.e. olopatadine and desloratadine) also relaxed airway segments. These data support the notion that MP-AzeFlu has the ability to activate Tas2R in the same way as chloroquine. The effect appears to be mediated by AZE, but not via the histamine receptor. Activation of Tas2R by MP-AzeFlu may contribute to its superior efficacy over FP observed in controlled clinical trials in patients with moderate/severe allergic rhinitis.

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“…The poor bioavailability of suspended drugs is also illustrated by a study where different doses of budesonide in suspension (64 µg vs 256 µg per day) have been applied in patients suffering from AR: both doses were similarly effective suggesting that increased amounts of undissolved drug do not contribute efficiently to the clinical response. 5 Different combinations of corticosteroids and anti-histamines have been evaluated in clinical trials, showing superior efficacy compared to either of the components alone, [6][7][8] but for only one of these combinations a market authorization and real-world evidence exist yet. 9,10 The lag time is shortened, as the anti-histamines exert their function early on, while the corticosteroids address the inflammation later.…”

Section: Introductionmentioning

confidence: 99%

Fast effectiveness of a solubilized low‐dose budesonide nasal spray in allergic rhinitis

Zieglmayer

Schmutz

Lemell

et al. 2020

Clin Experimental Allergy

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Background Budesonide, a poorly water‐soluble corticosteroid, is currently marketed as a suspension. Budesolv is a novel aqueous formulation containing dissolved budesonide showing increased local availability in preclinical models. Budesolv contains ~85% less corticosteroid than the marketed comparator. Objective The study (EudraCT:2018‐001324‐19) was designed to assess non‐inferiority of Budesolv compared to Rhinocort® Aqua 64 (RA) and early onset of action. Methods In a three‐way cross‐over double‐blinded randomized trial, Budesolv 10 was compared to RA and placebo in grass pollen allergic rhinoconjunctivitis volunteers (n = 83 (ITT); n = 75 (PP)). On day 1, participants entered the Vienna Challenge Chamber (VCC) for 6 hours; first treatment took place at 1:45 hours after entry. Participants treated themselves for further 6 days; on day 8, the last treatment was applied before entering the VCC. Subjective symptom scores, nasal airflow and nasal secretion were measured regularly during allergen challenge. Results Budesolv 10 was equally effective compared to RA with respect to TNSS and nasal airflow after eight days of treatment with a strongly reduced dose (more than 80% reduction). After first dose, only Budesolv 10 showed a significant reduction of nasal and respiratory symptoms starting 90 minutes (P < .05) and 15 minutes (P < .05) after application onwards, respectively, demonstrating an early onset of efficacy. A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (P < .05) after application. Conclusions and clinical relevance The novel preservative‐free, aqueous low‐dose budesonide formulation is highly efficacious even after an initial single treatment. Thus, Budesolv 10 appears to be an effective acute treatment for allergic rhinitis as well as for AR comorbidities like mild asthma and conjunctivitis.

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Superior effect of MP-AzeFlu than azelastine or fluticasone propionate alone on reducing inflammatory markers

Cited by 12 publications

References 55 publications

Evaluating the real-life effect of MP-AzeFlu on asthma outcomes in patients with allergic rhinitis and asthma in UK primary care

Evaluating the real-life effect of MP-AzeFlu on asthma outcomes in patients with allergic rhinitis and asthma in UK primary care

Effects of MP-AzeFlu enhanced by activation of bitter taste receptor TAS2R

Fast effectiveness of a solubilized low‐dose budesonide nasal spray in allergic rhinitis

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