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James F Donohue,1 J Stuart Elborn,2 Peter Lansberg,3 Afzal Javed,4 Solomon Tesfaye,5 Hope Rugo,6 Sita Ratna Devi Duddi,7,8 Niraksha Jithoo,9 Pai-Hui Huang,10 Kannan Subramaniam,11 Nagendra Ramanjinappa,12 Arkady Koltun,13 Shari Melamed,13 Juliana CN Chan14 1UNC School of Medicine, Chapel Hill, NC, USA; 2Queen’s University, Belfast, UK; 3University Medical Center, Groningen, the Netherlands; 4Warwick Medical School, University of Warwick, Warwick, UK & Pakistan Psychiatric Research Centre, Coventry, UK; 5Sheffield Teaching Hospitals and the University of Sheffield, Sheffield, UK; 6University of California San Francisco Comprehensive Cancer Center, San Francisco, CA, USA; 7International Alliance of Patients’ Organisations, London, United Kingdom; 8DakshamA Health and Education, Delhi, India; 9Viatris Ltd, Johannesburg, South Africa; 10Viatris Pharmaceutical Co., Ltd, Taipei, Taiwan; 11Viatris Ltd, Auckland, New Zealand; 12Viatris Ltd, Bangalore, India; 13Viatris Ltd, Canonsburg, PA, USA; 14Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity, Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, Special Administrative Regions of the People’s Republic of ChinaCorrespondence: Juliana CN Chan, Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity, Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, Special Administrative Regions of the People’s Republic of China, Tel +852 3505 3138, Email jchan@cuhk.edu.hkAbstract: According to the United Nations High-Level Meeting 2018, five non-communicable diseases (NCDs) including cardiovascular diseases, chronic respiratory diseases, diabetes mellitus, cancer, and mental health conditions accounted for two-thirds of global deaths. These five NCDs share five common risk factors including tobacco use

Gabriella Gálffy,1 Melanie Emmeluth,2 Arkady Koltun,3 Ferdinand Kopietz,2 Duc Tung Nguyen,2 Hans Christian Kuhl2 1Onco-Pulmonology Department, Pest County Pulmonology Hospital, Törökbálint, Hungary; 2Global Medical Affairs, MEDA Pharma GmbH & Co. KG (A Mylan Company), Bad Homburg, Germany; 3Global Medical Affairs, Mylan, Inc, Canonsburg, PA, USACorrespondence: Gabriella GálffyHead of the Onco-Pulmonology Department and Research and Education Director of Pest County Pulmonology Hospital, Törökbálint 70, Munkácsy Mihály Street, Törökbálint, 2045, HungaryFax +36-23511598Email ggalffy@hotmail.comBackground: Allergic rhinitis (AR) is characterized by nasal and ocular symptoms, and substantially impacts the quality of life. Therapy selection for patients with AR depends on several factors, including symptom severity, age, patient preference, patient adherence, and cost.Methods: The purpose of this multicenter, noninterventional, cross-sectional survey was to evaluate current therapy decisions in routine clinical practice for patients with symptomatic AR, and to determine how these decisions are linked to experiences with previous treatments and current symptom severity as assessed by aVAS. The survey included patients aged 18 years or older in Spain and 12 years or older in Hungary who consulted a physician for treatment of AR symptoms. Physicians recorded AR symptom burden in the previous 7 days, previous AR treatments, and the current AR therapy decision made at the visit.Results: Overall, 72.9% of 181 patients (Spain) and 67.1% of 228 patients (Hungary) had received treatment in the previous 7 days. Among patients who had received step 3 treatment, 82.9% (Spain) and 75.8% (Hungary) received a free combination of intranasal corticosteroid (INCS) and antihistamines. Despite the high number of pretreated pati

Gabriella Gálffy,1 Melanie Emmeluth,2 Arkady Koltun,3 Ferdinand Kopietz,2 Duc Tung Nguyen,2 Hans Christian Kuhl2 1Onco-Pulmonology Department, Pest County Pulmonology Hospital, Törökbálint, Hungary; 2Global Medical Affairs, MEDA Pharma GmbH & Co. KG (A Mylan Company), Bad Homburg, Germany; 3Global Medical Affairs, Mylan, Inc, Canonsburg, PA, USACorrespondence: Gabriella GálffyHead of the Onco-Pulmonology Department and Research and Education Director of Pest County Pulmonology Hospital, Törökbálint 70, Munkácsy Mihály Street, Törökbálint, 2045, HungaryFax +36-23511598Email ggalffy@hotmail.comBackground: Allergic rhinitis (AR) is characterized by nasal and ocular symptoms, and substantially impacts the quality of life. Therapy selection for patients with AR depends on several factors, including symptom severity, age, patient preference, patient adherence, and cost.Methods: The purpose of this multicenter, noninterventional, cross-sectional survey was to evaluate current therapy decisions in routine clinical practice for patients with symptomatic AR, and to determine how these decisions are linked to experiences with previous treatments and current symptom severity as assessed by aVAS. The survey included patients aged 18 years or older in Spain and 12 years or older in Hungary who consulted a physician for treatment of AR symptoms. Physicians recorded AR symptom burden in the previous 7 days, previous AR treatments, and the current AR therapy decision made at the visit.Results: Overall, 72.9% of 181 patients (Spain) and 67.1% of 228 patients (Hungary) had received treatment in the previous 7 days. Among patients who had received step 3 treatment, 82.9% (Spain) and 75.8% (Hungary) received a free combination of intranasal corticosteroid (INCS) and antihistamines. Despite the high number of pretreated pati

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 +31 592 325229Fax +31 592 325226Email r.van.weissenbruch@wza.nlPurpose: 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

William E Berger,1 Claus Bachert,2 Robert Allara,3 Arkady Koltun,4 Ferdinand Kopietz,5 Joachim G Maus,5 Alexander D D’Addio3 1Allergy and Asthma Associates of Southern California, Mission Viejo, CA, USA; 2Ghent University Hospital, Ghent, Belgium; 3Meda Pharmaceuticals, Somerset, NJ, USA; 4Mylan Inc., Canonsburg, PA, USA; 5Meda Pharma GmbH & Co. KG (a Mylan Company), Bad Homburg, GermanyCorrespondence: William E BergerAllergy and Asthma Associates of Southern California, 27800 Medical Center Road #244, Mission Viejo, CA, USATel + 949-364-2900Fax + 949-365-0117Email weberger@uci.eduPurpose: Most patients with allergic rhinitis (AR) have moderate-to-severe disease, requiring complete and prompt relief when symptoms occur. The time course of fluticasone propionate (FP) penetration into nasal tissues after intranasal administration is not well characterized. The goal of this proof-of-concept study was to evaluate the mucosal penetration of FP from fixed-combination FP-azelastine nasal spray (MP-AzeFlu) compared with an FP-only nasal spray in an in vitro, 3-dimensional human bronchial tissue model.Materials and Methods: Absorption of FP from MP-AzeFlu and FP nasal spray was modeled using EpiAirway™ 606 (MatTek Corporation; Ashland, MA, USA) tissue cultured in vertical diffusion cells. The dosing amount of MP-AzeFlu was optimized in a pilot study. Based on the results of the pilot study, 10 μL of MP-AzeFlu (3.65 μg; n = 8) and 10 μL of FP nasal spray (5.00 μg; n = 8) were evaluated for penetration of tissue. Tissue integrity was monitored with Lucifer yellow. FP in the receiving media was quantified for each sample using liquid chromatography with tandem mass spectrometry.Results: MP-AzeFlu and FP nasal spray were associated with similar FP accumulation profiles in the receiving media, but the permeability of FP was greater for MP-AzeFlu during hours 0 to 6, suggesting faster absorption for MP-AzeFlu. No indications

William E Berger,1 Claus Bachert,2 Robert Allara,3 Arkady Koltun,4 Ferdinand Kopietz,5 Joachim G Maus,5 Alexander D D’Addio3 1Allergy and Asthma Associates of Southern California, Mission Viejo, CA, USA; 2Ghent University Hospital, Ghent, Belgium; 3Meda Pharmaceuticals, Somerset, NJ, USA; 4Mylan Inc., Canonsburg, PA, USA; 5Meda Pharma GmbH & Co. KG (a Mylan Company), Bad Homburg, GermanyCorrespondence: William E BergerAllergy and Asthma Associates of Southern California, 27800 Medical Center Road #244, Mission Viejo, CA, USATel + 949-364-2900Fax + 949-365-0117Email weberger@uci.eduPurpose: Most patients with allergic rhinitis (AR) have moderate-to-severe disease, requiring complete and prompt relief when symptoms occur. The time course of fluticasone propionate (FP) penetration into nasal tissues after intranasal administration is not well characterized. The goal of this proof-of-concept study was to evaluate the mucosal penetration of FP from fixed-combination FP-azelastine nasal spray (MP-AzeFlu) compared with an FP-only nasal spray in an in vitro, 3-dimensional human bronchial tissue model.Materials and Methods: Absorption of FP from MP-AzeFlu and FP nasal spray was modeled using EpiAirway™ 606 (MatTek Corporation; Ashland, MA, USA) tissue cultured in vertical diffusion cells. The dosing amount of MP-AzeFlu was optimized in a pilot study. Based on the results of the pilot study, 10 μL of MP-AzeFlu (3.65 μg; n = 8) and 10 μL of FP nasal spray (5.00 μg; n = 8) were evaluated for penetration of tissue. Tissue integrity was monitored with Lucifer yellow. FP in the receiving media was quantified for each sample using liquid chromatography with tandem mass spectrometry.Results: MP-AzeFlu and FP nasal spray were associated with similar FP accumulation profiles in the receiving media, but the permeability of FP was greater for MP-AzeFlu during hours 0 to 6, suggesting faster absorption for MP-AzeFlu. No indications

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 +31 592 325229Fax +31 592 325226Email r.van.weissenbruch@wza.nlPurpose: 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

Nicola A Hanania,1 Sanjay Sethi,2 Arkady Koltun,3 Jonathan K Ward,4 Jacqui Spanton,4 Dik Ng4 1Asthma Clinical Research Center, Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA; 2Pulmonary, Critical Care, and Sleep Medicine, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA; 3Global Medical Affairs, Mylan Inc., Canonsburg, PA, USA; 4Mylan Global Respiratory Group, Mylan Pharma UK Ltd., Sandwich, Kent, UK Background: Formoterol fumarate inhalation solution (FFIS; Perforomist®) is a long-acting β2-agonist (LABA) marketed in the US as a nebulized COPD maintenance treatment. Because long-term LABA use was associated with a potential increased risk of exacerbation or death in asthma patients, the US Food and Drug Administration (FDA) requested a postmarketing commitment study to evaluate long-term safety in COPD patients. Methods: This was a multicenter, randomized, double-blind, placebo-controlled, noninferiority study. Patients (N=1,071; mean age, 62.6 years; 48.5% male; 89.7% white) with moderate-to-severe COPD on stable COPD therapy received FFIS (20 µg; n=541) or placebo (n=530) twice daily. The primary end point was the combined incidence of respiratory death, first COPD-related ER visit, or first COPD exacerbation-related hospitalization during 1 year post randomization. Noninferiority to placebo was concluded if the two-sided 90% CI of the HR of FFIS to placebo was <1.5. Secondary end points included spirometry. Results: The planned 1-year treatment period was completed by 520 patients; 551 discontinued prematurely (FFIS: 45.7%; placebo: 57.4%). The median treatment duration was approximately 10 and 7 months for FFIS and placebo, respectively. Among 1,071 randomized patients, 121 had ≥1 primary event (FFIS: 11.8%; placebo: 10.8%). The estimated HR of a primary event with FFIS vs placebo was 0.965 (90% CI: 0.711, 1.308), demonstrati