MP-AzeFlu Improves the Quality-of-Life of Patients with Allergic Rhinitis

Abstract

Ranny van Weissenbruch,1 Ludger Klimek,2 Gabriella Gálffy,3 Melanie Emmeluth,4 Arkady Koltun,5 Ferdinand Kopietz,4 Duc Tung Nguyen,6 Hans Christian Kuhl,4 Wolfgang Pohl,7 Glenis K Scadding,8 David Price,9,10 Joaquim Mullol11 1Department of ENT Head and Neck Surgery, Wilhelmina Ziekenhuis, Assen, the Netherlands; 2Department of Otorhinolaryngology and Head and Neck Plastic Surgery, Zentrum für Rhinologie und Allergologie, Wiesbaden, Germany; 3Pulmonology Hospital, Torokbalint, Hungary; 4Global Medical Affairs, MEDA Pharma GmbH & Co. KG (A Mylan Company), Bad Homburg, Germany; 5Mylan, Inc., Canonsburg, PA, USA; 6GBK Clinical Affairs, MEDA Pharma GmbH & Co. KG (A Mylan Company), Bad Homburg, Germany; 7Department of Respiratory and Pulmonary Diseases, Karl Landsteiner Gesellschaft, Institute of Clinical and Experimental Pneumology, Vienna, Austria; 8Roy National Throat Nose and Ear Hospital, London, UK; 9Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 10Observational and Pragmatic Research Institute, Singapore, Singapore; 11Rhinology Unit & Smell Clinic, ENT Department, Hospital Clinic Barcelona IDIBAPS University of Barcelona, CIBERES, Barcelona, Catalonia, SpainCorrespondence: Ranny van WeissenbruchWilhelmina Ziekenhuis, Europaweg-Zuid 1, Assen 9401 RK, the NetherlandsTel [phone]Fax [phone]Email [email protected]: Patients with poorly controlled allergic rhinitis (AR) experience nasal symptoms, sleep disturbances, activity impairment, and decreased quality-of-life (QoL). MP-AzeFlu is safe and effective for moderate-to-severe seasonal and perennial AR, but its impact on QoL requires investigation in the real-world, especially among phenotypes of immunoglobulin (Ig)E-mediated AR. This subanalysis of an observational study evaluated response to MP-AzeFlu via assessment of sleep quality and trouble with daily activities.Patients and Methods: This multicenter, prospective, non-interventional, real-life study included a convenience sample of patients with a history of moderate-to-severe AR presenting with acute AR symptoms (visual analog scale [VAS] ≥ 50 mm). Over approximately 14 days of treatment with MP-AzeFlu (137 μg azelastine HCL and 50 μg fluticasone propionate administered via single 0.137-mL spray in each nostril twice daily), changes in sleep quality and trouble with daily work, school, social, and outdoor activities were evaluated using a VAS for the entire study population and for four subgroups based on IgE response phenotype. VAS scores ranged from “not at all troubled” (0 mm) to “extremely troubled” (100 mm).Results: Following MP-AzeFlu treatment, mean VAS scores for sleep quality impairment and work or school impairment decreased from 55.2 mm at baseline to 22.1 mm and 57.6 mm at baseline to 23.0 mm, respectively, after ∼ 14 days. Similar results were observed for mean VAS scores for impairment of social activity (55.1 mm to 22.4 mm) and impairment of outdoor activity (64.4 mm to 25.0 mm). For all VAS scores, results were similar across populations, regardless of phenotype of IgE-mediated disease, comorbidity, age, and sex.Conclusion: MP-AzeFlu relieves symptoms and improves patient-reported QoL, illustrated by better sleep quality and less impairment of work, school, social, and outdoor activities after 14 days. The QoL benefits of MP-AzeFlu were consistent regardless of the phenotype of IgE-mediated disease.Registration: Clinical Trial Registration (CTR) Number: EUPAS23075. Trial Register Date: March 12, 2018. First patient visit; Last patient visit: February 2018; April 2019.Keywords: azelastine hydrochloride, daily activities, fluticasone propionate, sleep

Keywords

• azelastine hydrochloride
• daily activities
• fluticasone propionate
• sleep