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    ABSTRACT: The efficacy of MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in an advanced delivery system) has been well established in controlled clinical trials. This study was designed to assess the use of MP29-02 and its effectiveness in routine clinical practice. This was a German multicenter, prospective, noninterventional study, including 1781 allergic rhinitis (AR) patients. Eligible patients (i.e., acute AR symptoms and visual analog scale [VAS] score >50 mm) were included, assigned MP29-02 at baseline, and reassessed after ∼14 days. Patients assessed symptom control using a VAS from 0 (not at all bothersome) to 100 mm (very bothersome) in the morning before MP29-02 use, on days 0, 1, 3, and 7 and after ∼ 14 days. Patients' perceived levels of disease control were assessed on day 3. The Youden index determined patient-reported VAS score cutoffs on day 3 for “well controlled” and “partly controlled.” MP29-02 reduced the VAS score from 75.4 mm (SD = 17.2) at baseline to 21.3 mm (SD = 18.3) by the last visit, a shift of 54.1 mm (SD = 24.6). One in every two patients felt their symptoms were well controlled at day 3. This perception of well-controlled symptoms at day 3 corresponded to an optimal VAS cutoff of 36 mm. On average, patients treated with MP29-02 crossed this well-controlled VAS cutoff by last visit. Similar results were found in adolescents, adults, and older adults, in those with perennial AR (PAR), seasonal AR (SAR), or PAR + SAR and in those with more and less severe disease. MP29-02 provides effective and rapid symptom control across all age groups in a real-life setting with responder rates higher than those observed in controlled clinical trials, supporting MP29-02's position as the drug of choice for the treatment for AR.
    Allergy and Asthma Proceedings 02/2015; 36(1). DOI:10.2500/aap.2015.36.3823 · 3.35 Impact Factor
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    ABSTRACT: There is no shortage of pharmacologic treatments available for the management of allergic rhinitis (AR), but none regularly provide full relief from all symptoms. MP29-02 (Dymista®) is a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP), benefiting from an enhanced formulation and improved device characteristics compared to marketed intranasal corticosteroid (INS) formulations. Results from large, randomized, double-blind, placebo-controlled, head-to-head trials versus first-line therapies, confirmed MP29-02 as the evidence-based drug-of-choice for AR treatment. MP29-02 was twice as effective as AZE or FP for nasal and ocular symptom relief in moderate to severe seasonal AR patients, with superiority documented regardless of season, and in more severe patients. More MP29-02-treated patients experienced clinically relevant responses (i.e., halving of nasal symptom burden and complete/near-to-complete relief) days faster than those on INS or intranasal antihistamine monotherapy. MP29-02's efficacy was sustained long-term versus FP (up to 52 weeks) in chronic rhinitis patients (perennial AR or nonallergic rhinitis), with 7 out of 10 patients first becoming symptom-free following 1 month's treatment with MP29-02, and days faster than with the INS. These results confirm MP29-02's superiority over the historical gold-standard therapy for AR (i.e., INS), and position it now as first-line treatment for moderate to severe AR patients, the majority of whom are uncontrolled on existing medications.
    Drugs of today (Barcelona, Spain: 1998) 01/2014; 50(1):15-31. DOI:10.1358/dot.2014.50.1.2094806 · 1.00 Impact Factor
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    ABSTRACT: Background: Allergic rhinitis (AR) is a highly prevalent disease that affects the quality of life, especially in the “severe chronic upper airway disease” (SCUAD) group of patients who still have severe symptoms after adequate treatment. This study investigated the prevalence of uncontrolled AR and SCUAD consulting in the Allergy Department of Tongji Hospital, Wuhan, China. Methods: In this prospective cohort study, all patients consulting for AR were prospectively assessed using visual analog scale (VAS) and Allergic Rhinitis Control Test (ARCT) and put on standardized treatment based on the Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines. After 15 days, they were reevaluated by a telephone interview using a numerical scale (NS) and ARCT. A score of ARCT of Results: A total of 252 patients were included. Moderate/severe AR (VAS ≥ 5) was diagnosed in 82.9% of the patients which had an impact on sleep (86.9%), work life (84.9%), social activities (81%), and physical activities (90.1%). Patients with uncontrolled AR (27.7%) at day 15 more frequently presented a higher weight (p = 0.042), history of ear, nose, and throat (ENT) infection or antibiotics intake for respiratory infection in the last 12 months (62.3% versus 45.6%; p = 0.018), smoking (15.9% versus 6.7%; p = 0.024), and smell disturbance (26.1% versus 11.7%; p = 0.005). Patients with SCUAD (24.5%) more frequently presented a history of ENT infection or antibiotics intake for respiratory infection in the last 12 months (63.9% versus 45.7%; p = 0.014) and smell disturbance (27.9% versus 11.7%; p = 0.003), and less commonly had atopic dermatitis (13.1% versus 28.2%; p = 0.017). Conclusion: Uncontrolled AR and SCUAD patients are numerous. VAS and ARCT are simple and quantitative methods and self-completion questionnaires that can be used for a global evaluation of the severity and control of AR.
    American journal of rhinology & allergy 10/2014; 28(5). DOI:10.2500/ajra.2014.28.4079 · 2.18 Impact Factor