Funding for this research was provided by:
Received: 4 January 2022
Accepted: 4 January 2023
First Online: 20 January 2023
: All patients provided written informed consent prior to participation in the SYNAPSE study. The study was approved by the local institutional review board or ethics committee at each study center. The approving ethics committees were as follows: <i>Argentina</i>: Comite de Etica Dr. Claude Bernard, San Lorenzo 2555, Rosario, Santa Fe, S2000KPG; Comite de etica en Investigacion CEMER, Esmeralda 1550, Florida, Buenos Aires, B1602DQD; Comité Independiente de ética para ensayos en Farmacología Clinica del centro Medico Dra. De Salvo, Avenida Cabildo 1536 5° B, Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP; Comité de Ética en Investigación. INAER, Arenales 3146 1°A, Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425BEN; Framingham Centro Médico, Calle 9 Numero 431, La Plata, Buenos Aires, B1902COS; Comite de Etica en Farmacologia Clinica de la Fundacion CIDEA, Paraguay 2041, Ciudad Autonoma de Buenos Aires, CP1121ABE; Investigaciones en Alergia y Enfermedades Respiratorias, Arenales 3146, Buenos Aires, C1425BEN; Comite de Etica en Investigacion, Instituto Ave Pulmo, Carlos M. Alvear 3345, Mar del Plata, Buenos Aires, B7602DCK; <i>Australia</i>: Saint Vincent’s Hospital, Research Office, Level 6, DeLacy Building, Darlinghurst, New South Wales, 2010; Bellberry Limited, 123 Glen Osmond Road, Eastwood, South Australia, 5063; <i>Canada</i>: Comité d'éthique de la recherche du CHU de Québec, A0-124, Comité d'éthique de la recherche du CHU de Québec, Quebec, Québec, G1L 3L5; Advarra, Suite 300, 372 Hollandview Trail, Aurora, Ontario, L4G 0A5; Comite d’ethique de la Recherche du CHUM, Tour Viger, 3e étage, 900, rue St-Denis, Montréal, Québec, H2X 0A9; UBC CREB Office, 210, 828 West 10th Avenue, Vancouver, British Columbia, V5Z 1L8; Hamilton Integrated Research Ethics Board, Suite 102, 293 Wellington Street North, Hamilton, Ontario, L8L 8E7; Western University, Office of Research Ethics, Support Services Building Room 5150, 1151 Richmond Street, London, Ontario, N6G 1G9; University of Saskatchewan, Thorvaldson Building, Room 223, Research Services and Ethics Office, University of Saskatchewan, Saskatoon, Saskatchewan, S7N 5C9; <i>Germany</i>: Ethik-Kommission der Landesaerztekammer Hessen, Im Vogelsgesang 3, Frankfurt, Hessen, 60488; <i>Republic of Korea</i>: Severance Hospital Clinic Trial Centre, Yonsei University Health System, 50-1 Yonsei-Ro Seodaemun-Gu, Seoul, 03722; Samsung Medical Centre, 81 Irwon-Ro Gangnam-gu, Seoul, 06351; Gachon University of Gil Medical Centre, 21, Namdong-daero 774 bean-gil, Namdong-gu, 21565; The Catholic University of Korea Seoul Saint Mary’s Hospital, 222 Banpo-Daero, Seocho-gu, Seoul, 06591; Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul, 08308; Seoul National University Bundang Hospital, 82 Gumi-ro 173 beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, 13620; <i>Netherlands</i>: Medisch Ethische Commissie, Meibergdreef 9, Amsterdam, 1105 AZ; <i>Romania</i>: Comisia Nationala de Bioetica a medicamentelor si a Dispozitivelor Medicale, Pavilion K, Spitalul Clinic Colentina, Sos. Stefan cel Mare near 19-21, Bucuresti, 020125; <i>Russia</i>: Independent Ethics Committee PharmNadzor, office 618, 4, Komendantskiy Prospect, Lit.A, Saint-Petersburg, 197227; GOU VPO Saint.Petersburg State Medical University "I.P.Pavlova", 6\8,Lva Tolstogo, Saint Petersburg, 197022; Federal medical biophysical center n.a. A.I. Burnazyan of FMBA of Russia, 23, Marshala Novikova Strasse., Moscow, 123098; Hospital of Russian Academy of Science, Troitsk city, Oktyabrskiy prospect, 3, Moscow, 142190; Inter-Institutional ETHICS COMMITTEE, per. Gagarinskiy, d. 37, Strasse. 2, Moscow, 119002; Scientific Clinical Center of Otorhinolaryngology, 30/2, Volokolamskoe shosse, Moscow, 123182; ENT Research Institute, 9, Bronnitskaya Street, Saint-Petersburg, 190013; I.M. Sechenov First Moscow State Medical University, Local Ethics Committee of Federal State Autonomous Educational Institution of Higher Education, 8, ul. Trubetskaya, Moscow, 119991; I.M.Sechenov First Moscow State Medical University of Ministry of health and social development, Local Ethics Committee of State budget educational institution of higher professional education, 8 Trubetskaya street, Moscow; Municipal Health Care Institution Clinical Hospital for Emergency Medical Care, 11 Zagorodny Sad., Yaroslavl, 150003; <i>Sweden</i>: Regionala Etikprövningsnämnden i Göteborg, Guldhedsgatan 5A, Göteborg, SE-413 20; <i>United Kingdom</i>: NRES Committee East Midlands-Leicester, The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; <i>United States of America</i>: University of Utah Institutional Review Board, Research Administration Building, 75 South 2000 East, Salt Lake City, Utah, 84112; Advarra Institutional Review Board, Suite 110, 6940 Columbia Gateway Drive, Columbia, Maryland, 21046; Penn State college of Medicine Institutional Review Board/Human Subjects Protection Office, Penn State Hershey Medical Center, Mailcode A115, 90 Hope Drive, Hershey, Pennsylvania, 17033, 855; University of California, San Diego (UCSD) Human Research Protection Program Office (HRPP), 9452 Medical Center drive, La Jolla, California, 92093; University of Texas Southwestern Medical Center Institutional Review Board, Room BL9.100, 5323 Harry Hines Boulevard, Dallas, Texas, 75390-8843; Office of Research Integrity, Institutional Review for Human Research, 19 Hagwood Avenue, Suite 601, Charleston, South California, 29425.
: Not applicable.
: WF has received clinical trial funding from Sanofi, Mylan, ALK, Allergy Therapeutics, Novartis, and Chordate, personal fees from GSK, Sanofi and Novartis, has participated on an advisory board for Lyra, and is Secretary General of the European Rhinologic Society. AT was employed by Adelphi Values during the conduct of the study and is currently an employee of Bayer Plc. SEL has participated in advisory boards and received clinical trial funding from Sanofi Genzyme, Regeneron, Genentech, AstraZeneca, and GSK. RHC, PH, BM, ARS and SY are all employees of GSK and own stocks/shares in GSK. MT was an employee of GSK at the time of the study and owns stocks/shares in GSK. ZD has acted as Research Director at QPS-NL, an institution which has received research support from HAL Allergy, Foresee Pharmaceuticals, Patara Pharma (now Respivant) and Novartis. ZD has also received honoraria or speaker fees serving on advisory boards or as a consultant for ALK, Antabio, AstraZeneca, Boehringer Ingelheim, Merck Sharp & Dohme, QPS-NL and Sanofi-Genzyme-Regeneron. CH has received advisory board fees from Sanofi, AstraZeneca, Olympus, Dianosic, and GSK, and has received honoraria for lectures from GSK, Sanofi, Intersect, and Mylan. VL reports advisory board and lecture fees from GSK, Novartis, and Sanofi.