Allergic rhinitis and asthma symptoms in a real-life study of MP-AzeFlu to treat multimorbid allergic rhinitis and asthma

David Price, Ludger Klimek, Gabriella Gálffy, Melanie Emmeluth, Arkady Koltun, Ferdinand Kopietz, Duc Tung Nguyen, Ranny van Weissenbruch, Wolfgang Pohl, Hans-Christian Kuhl, Glenis Scadding, Joaquim Mullol, David Price, Ludger Klimek, Gabriella Gálffy, Melanie Emmeluth, Arkady Koltun, Ferdinand Kopietz, Duc Tung Nguyen, Ranny van Weissenbruch, Wolfgang Pohl, Hans-Christian Kuhl, Glenis Scadding, Joaquim Mullol

Abstract

Background: Asthma affects up to nearly 40% of patients with allergic rhinitis (AR). Poor control of AR symptoms is associated with poor asthma control. The goal of this study was to evaluate the effect of AR treatment with MP-AzeFlu on symptoms of AR as well as symptoms of asthma.

Methods: This prospective study used a visual analog scale (VAS) to assess symptoms of AR and asthma before and after treatment with MP-AzeFlu (Dymista®; azelastine hydrochloride plus fluticasone propionate; 1 spray in each nostril twice daily for 2 weeks). Participants suffered from moderate-to-severe AR according to Allergic Rhinitis and its Impact on Asthma criteria, with acute AR symptoms (AR-VAS scores ≥ 50 mm) on inclusion day. In addition to symptom assessment, patients recorded the impact of AR symptoms on quality-of-life measures before, during, and at the conclusion of the treatment period (approximately 14 days). Patients self-reported change in frequency of their usage of asthma reliever medication on the last day of treatment.

Results: Of 1103 study participants, 267 (24.2%) had comorbid asthma. These participants reported using a mean of 5.1 puffs of asthma reliever medication in the week before treatment with MP-AzeFlu. A total of 81.8% of patients with comorbid asthma responded to AR therapy (AR-VAS < 50 mm on at least 1 study day). Among patients with AR and comorbid asthma, MP-AzeFlu was associated with improved VAS scores across all study parameters, including AR symptom severity, asthma symptom severity, sleep quality, daily work or school activities, daily social activities, and daily outdoor activities. Asthma symptom severity decreased from a mean of 48.9 mm to 24.1 mm on the VAS. Self-reported frequency of asthma reliever medication use was reduced for 57.6% of participants (n = 139/241).

Conclusion: MP-AzeFlu used to relieve AR symptoms was associated with reduced asthma symptom VAS scores and frequency of asthma reliever medication usage. Changes in overall symptoms of AR and asthma were correlated.

Keywords: Allergic rhinitis; Asthma; Comorbidity; Daily activity; MP-AzeFlu; Sleep quality; Visual analog scale.

Conflict of interest statement

Competing interestsDP has board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Napp, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, and Teva Pharmaceuticals; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals, and Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through The Observational & Pragmatic Research Institute Pte Ltd) from AKL Research and Development Ltd, AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Circassia, Mylan, Mundipharma, Napp, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service, and Zentiva (Sanofi Generics); payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, and Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma and Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma and Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Circassia, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals; funding for patient enrollment or completion of research from Chiesi, Novartis, Teva Pharmaceuticals, and Zentiva (Sanofi Generics); stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and United Kingdom) and 74% of The Observational & Pragmatic Research Institute Pte Ltd (Singapore); and is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation Programme and Health Technology Assessment. JM has conducted research/received research grant support or speaker/consultancy fees from Mylan-Meda Pharma within this work. He has conducted research/received research grant support or speaker/consultancy fees from Allakos, ALK-Abelló, AstraZeneca, Genentech – Roche, GlaxoSmithKline, Mylan-Meda Pharma, Menarini Group, Mitsubishi-Tanabe, MSD, Novartis, SANOFI-Genzyme & Regeneron, UCB Pharma, and Uriach Group outside this work.

© The Author(s) 2020.

Figures

Fig. 1
Fig. 1
Changes in AR-VAS Scores With MP-AzeFlu Treatment. Time course of mean (SEM) VAS scores of AR symptoms from day 0 to the last trial day (a) in the total study population and (b) stratified by the presence of comorbid asthma. AR, allergic rhinitis; SD, standard deviation; SEM, standard error of the mean; VAS, visual analog scale
Fig. 2
Fig. 2
Changes in Asthma-VAS Scores With MP-AzeFlu Treatment. Time course of mean (SEM) VAS of asthma symptoms from day 0 to lthe last trial day among patients with comorbid AR and asthma. AR, allergic rhinitis; SD, standard deviation; SEM, standard error of the mean; VAS, visual analog scale
Fig. 3
Fig. 3
Changes in Troublesomeness of Sleep Quality VAS Scores With MP-AzeFlu Treatment. Time course of mean (SEM) VAS of change of troublesomeness of sleep quality from day 0 to the last trial day (a) in the total study population and (b) in subpopulations according to the presence of comorbid asthma. AR, allergic rhinitis; SD, standard deviation; SEM, standard error of the mean; VAS, visual analog scale
Fig. 4
Fig. 4
Changes in Troublesomeness of Daily Work and School Activities VAS Scores with MP-AzeFlu Treatment. Time course of mean (SEM) VAS of change of troublesomeness of daily work and school activities from day 0 to the last trial day (a) in the total study population and (b) in subpopulations according to the presence of comorbid asthma. AR, allergic rhinitis; SD, standard deviation; SEM, standard error of the mean; VAS, visual analog scale
Fig. 5
Fig. 5
Changes in Troublesomeness of Sleep Quality VAS Scores With MP-AzeFlu Treatment. Time course of mean (SEM) VAS of change of troublesomeness of sleep quality from day 0 to the last trial day (a) in the total study population and (b) in subpopulations according to the presence of comorbid asthma. AR, allergic rhinitis; SD, standard deviation; SEM, standard error of the mean; VAS, visual analog scale
Fig. 6
Fig. 6
Changes in Troublesomeness of Daily Outdoor Activities VAS Scores With MP-AzeFlu Treatment. Time course of mean (SEM) VAS of change of daily outdoor activities from day 0 to the last trial day (a) in the total study population and (b) in subpopulations according to the presence of comorbid asthma. AR, allergic rhinitis; SD, standard deviation; SEM, standard error of the mean; VAS, visual analog scale

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