Ruth Murray

Clinically relevant effect of a new intranasal therapy (MP29-02) in allergic rhinitis assessed by responder analysis.

Background: It is unclear what constitutes a clinically meaningful response for allergic rhinitis (AR) outcomes. The objectives of these post hoc analyses were (1) to define a clinically meaningful response using novel efficacy analyses (including a responder analysis), and (2) to compare the efficacy of MP29-02 [a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP)] with commercially available FP, AZE and placebo in seasonal AR (SAR) patients, using these novel analyses. Methods: 610 moderate-to-severe SAR patients (≥12 years old) were randomized into a double-blind, placebo-controlled, 14-day, parallel-group trial. Change from baseline in the reflective total nasal symptom score (rTNSS) over 14 days was the primary outcome. Post hoc endpoints included the sum of nasal and ocular symptoms (rT7SS), efficacy by disease severity and by predominant nasal symptom, and a set of responder analyses. Results: MP29-02 most effectively reduced rT7SS (relative greater improvement: 52% to FP; 56% to AZE) and both nasal and ocular symptoms irrespective of severity. More MP29-02 patients achieved a ≥30, ≥50, ≥60, ≥75 and ≥90% rTNSS reduction, which occurred days faster than with either active comparator; MP29-02 alone was superior to placebo at the ≥60% (or higher) threshold. One in 2 MP29-02 patients achieved a ≥50% rTNSS reduction and 1 in 6 achieved complete/near-to-complete response. Only MP29-02 was consistently superior to placebo for all patients, whatever their predominant symptom. Conclusions: MP29-02 provided faster and more complete symptom control than first-line therapies. It was consistently superior irrespective of severity, response criteria or patient-type, and may be considered the drug of choice for moderate-to-severe AR. These measures define a new standard for assessing relevance in AR.

Current controversies and challenges in allergic rhinitis management.

There are many obstacles in the path of effective allergy management, in general, and allergic rhinitis (AR) control, in particular. Chief among them are: insufficient symptom relief in some patients provided by some currently considered first-line AR treatments in real life; an over-reliance on randomized controlled trials to direct AR guideline recommendations; the need for a broader interpretation of the AR evidence base (to include randomized controlled trials and real-life studies); poorly designed and interpreted studies; and lack of an AR control concept and common language of control. These controversies are fully reviewed here and challenging solutions have been presented.

Comparison of intranasal azelastine to intranasal fluticasone propionate for symptom control in moderate-to-severe seasonal allergic rhinitis.

Intranasal corticosteroids are considered the most effective therapy for moderate-to-severe seasonal allergic rhinitis (SAR) and recommended first line in guidelines. It is uncertain whether intranasal antihistamines have comparable efficacy. This study was designed to compare the efficacy of azelastine (AZE; 137 μg/spray) and fluticasone propionate (FP; 50 μg/spray), both given as 1 spray/nostril bid (i.e., approved dosing regimen in the United States), in SAR via a post hoc analysis of data from a previously published direct-comparison study. Six hundred ten moderate-to-severe SAR patients (≥12 years old) were randomized into a double-blind, placebo-controlled, parallel-group trial. The primary efficacy variable was change from baseline in reflective total nasal symptom score (rTNSS (morning and evening), over 14 days. Reflective total ocular symptom score (rTOSS) was a key secondary variable. Reflective total of seven symptom scores (rT7SS [nasal plus ocular symptoms]) and time to ≥50% reduction from baseline in these key parameters were also analyzed. AZE and FP reduced rTNSS from baseline by a similar degree (-3.25 versus -3.84; p = 0.2014). Patients experienced comparable improvement in rTOSS (-2.62 versus -2.17; p = 0.2371) and rT7SS (-5.83 versus -6.05; p = 0.7820). FP was superior to AZE in alleviating rhinorrhea (-1.15 versus -0.87; p = 0.0433), but AZE showed comparable efficacy for all other nasal and ocular symptoms. There was no clinically or statistically significant difference between AZE (-1.17) and FP (-1.43) for reduction in the overall rhinitis quality of life questionnaire score (although FP, but not AZE, significantly differed from placebo). A similar proportion of patients in the AZE and FP groups achieved a 50% reduction in rTNSS. However, more AZE patients (53.0%) exhibited a 50% reduction in rTOSS by day 14 versus FP (39.6%), and ≤3 days faster (p = 0.028). Intranasal AZE (137 micrograms/spray) and intranasal FP (50 micrograms/spray), both 1 spray/nostril b.i.d., had comparable efficacy in symptom control in moderate-to-severe SAR.

Validation of the MASK‐rhinitis visual analogue scale on smartphone screens to assess allergic rhinitis control

Visual Analogue Scale (VAS) is a validated tool to assess control in allergic rhinitis patients.

Google Trends terms reporting rhinitis and related topics differ in European countries

Google Trends (GT) searches trends of specific queries in Google and reflects the real‐life epidemiology of allergic rhinitis. We compared Google Trends terms related to allergy and rhinitis in all European Union countries, Norway and Switzerland from 1 January 2011 to 20 December 2016. The aim was to assess whether the same terms could be used to report the seasonal variations of allergic diseases. Using the Google Trend 5‐year graph, an annual and clear seasonality of queries was found in all countries apart from Cyprus, Estonia, Latvia, Lithuania and Malta. Different terms were found to demonstrate seasonality depending on the country ‐ namely ‘hay fever’, ‘allergy’ and ‘pollen’ – showing cultural differences. A single set of terms cannot be used across all European countries, but allergy seasonality can be compared across Europe providing the above three terms are used. Using longitudinal data in different countries and multiple terms, we identified an awareness‐related spike of searches (December 2016).

Deposition characteristics of a new allergic rhinitis nasal spray (MP29-02*) in an anatomical model of the human nasal cavity

Background Intranasal sprays must be delivered to the nasal cavity in sufficient volume, appropriate viscosity and droplet size and with a technique that allows optimal retention, maximizes absorption from the mucosa, and the potential for maximum therapeutic effect. The aim of this study was to evaluate nasal drug run-off after administration of MP29-02* (a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) in an advanced delivery system) with sequential administration of marketed AZE and FP nasal sprays in vitro.

Daily allergic multimorbidity in rhinitis using mobile technology: a novel concept of the MASK study.

Multimorbidity in allergic airway diseases is well known, but no data exist about the daily dynamics of symptoms and their impact on work. To better understand this, we aimed to assess the presence and control of daily allergic multimorbidity (asthma, conjunctivitis, rhinitis) and its impact on work productivity using a mobile technology, the Allergy Diary.

Electronic Clinical Decision Support System for allergic rhinitis management: MASK e-CDSS

Allergic rhinitis (AR) management has changed in recent years following the switch from the concept of disease severity to the concept of disease control, publication of the AR clinical decision support system (CDSS) and development of mobile health (m‐health) tools for patients (eg Allergy Diary). The Allergy Diary Companion app for healthcare providers is currently being developed and will be launched in 2018. It incorporates the AR CDSS to provide evidence‐based treatment recommendations, linking all key stakeholders in AR management.

MP29-02* reduces eosinophil survival induced by epithelial cell secretions from nasal mucosa

Methods Peripheral blood eosinophils were incubated for 4 days with decreasing dilutions of MP29-02* (from 1:10 to 1:10 times), equivalent dilutions of FP (7.3x10M to 10M) or AZ (2.4x10M to 10M) prior to the addition of Epithelial Cell culture Media (ECM) from nasal mucosa (NM). Eosinophil survival was assessed by Trypan blue dye exclusion. Results are expressed as percentage (mean ± SEM) of eosinophil survival compared to control (100%).

Türkiye’de mask (Mobile Airways Sentinel networK) allerji günlüğü uygulaması: allerjik rinit ve astımda arıa ile bütünleşmiş mobil teknoloji kullanımı

mHealth, such as apps running on consumer smart devices is becoming increasingly popular and has the potential to profoundly affect healthcare and health outcomes. Allergic Rhinitis and its impact on asthma (ARIA) has evolved from a guideline using the best evidence-based approach to care pathways suited to real-life using mobile technology in allergic rhinitis (AR) and asthma multimorbidity MASK-rhinitis (Mobile Airways Sentinel networK), the Phase 3 ARIA initiative, is based on the freely available app. The Allergy Diary is used by people who were informed by physicians, searched the internet, Apple App Store, Google Play. Turkish Validation has been available and currently in use.