. 2020 Aug 14;20(1):212.

doi: 10.1186/s12874-020-01065-0.

International severe asthma registry (ISAR): protocol for a global registry

J Mark FitzGerald¹, Trung N Tran², Marianna Alacqua², Alan Altraja³, Vibeke Backer⁴, Leif Bjermer⁵, Unnur Bjornsdottir⁶, Arnaud Bourdin⁷, Guy Brusselle^{8

9}, Lakmini Bulathsinhala¹⁰, John Busby¹¹, Giorgio W Canonica^{12

13}, Victoria Carter¹⁰, Isha Chaudhry¹⁰, You Sook Cho¹⁴, George Christoff¹⁵, Borja G Cosio¹⁶, Richard W Costello¹⁷, Neva Eleangovan¹⁰, Peter G Gibson^{18

19}, Liam G Heaney²⁰, Enrico Heffler^{12

13}, Mark Hew²¹, Naeimeh Hosseini¹⁰, Takashi Iwanaga²², David J Jackson²³, Rupert Jones²⁴, Mariko S Koh²⁵, Thao Le¹⁰, Lauri Lehtimäki²⁶, Dora Ludviksdottir²⁷, Anke H Maitland-van der Zee²⁸, Andrew Menzies-Gow²⁹, Ruth B Murray¹⁰, Nikolaos G Papadopoulos^{30

31}, Luis Perez-de-Llano³², Matthew Peters³³, Paul E Pfeffer³⁴, Todor A Popov³⁵, Celeste M Porsbjerg³⁶, Chris A Price¹⁰, Chin K Rhee³⁷, Mohsen Sadatsafavi³⁸, Yuji Tohda²², Eileen Wang³⁹, Michael E Wechsler⁴⁰, James Zangrilli², David B Price^{41

42

43}

Affiliations

¹ The Institute for Heart Lung Health, Vancouver, Canada.
² AstraZeneca, Gaithersburg, USA.
³ Department of Pulmonary Medicine, University of Tartu and Lung Clinic, Tartu University Hospital, Tartu, Estonia.
⁴ Center of Physical Activity Research, Rigshospitalet and Copenhagen University, Copenhagen, Denmark.
⁵ Department of Respiratory Medicine & Allergology, Skåne University Hospital, Lund, Sweden.
⁶ Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
⁷ Department of Respiratory Diseases, Montpellier University Hospitals, Hopital Arnaud de Villeneuve and PhyMed Exp (INSERM U 1046, CNRS UMR9214), Universite de Montpellier, Montpellier, France.
⁸ Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
⁹ Departments of Epidemiology and Respiratory Medicine, Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands.
¹⁰ Optimum Patient Care, Cambridge, UK.
¹¹ Centre for Public Health, Queen's University Belfast, Belfast, UK.
¹² Personalized Medicine Asthma & Allergy Clinic, Humanitas University & Research Hospital, Milan, Italy.
¹³ SANI-Severe Asthma Network Italy, Milan, Italy.
¹⁴ Division of Allergy, Department of Medicine, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, South Korea.
¹⁵ Faculty of Public Health, Medical University - Sofia, Sofia, Bulgaria.
¹⁶ Son Espases University Hospital-IdISBa-Ciberes, Mallorca, Spain.
¹⁷ Clinical Research Centre, Smurfit Building Beaumont Hospital and Department of Respiratory Medicine, RCSI, Dublin, Ireland.
¹⁸ Australasian Severe Asthma Network, Priority Research Centre for Healthy Lungs, University of Newcastle, Newcastle, Australia.
¹⁹ Department of Respiratory and Sleep Medicine, Hunter Medical Research Institute, John Hunter Hospital, New Lambton Heights, Australia.
²⁰ Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.
²¹ Alfred Health & Monash University, Melbourne, Australia.
²² Department of Respiratory Medicine & Allergology, Faculty of Medicine, Kindai University Hospital, Ōsakasayama, Japan.
²³ Guy's & St Thomas' NHS Trust and King's College London, London, UK.
²⁴ Faculty of Medicine & Dentistry, University of Plymouth, Plymouth, UK.
²⁵ Department of Respiratory & Critical Care Medicine, Singapore General Hospital and Duke-National University Singapore Medical School, Singapore, Singapore.
²⁶ Allergy Centre, Tampere University Hospital and Tampere University, Tampere, Finland.
²⁷ Department of Respiratory Medicine, Faculty of Medicine, Landspitali University Hospital and University of Iceland, Reykjavik, Iceland.
²⁸ University of Amsterdam, Amsterdam, The Netherlands.
²⁹ Royal Brompton & Harefield NHS Foundation Trust, London, UK.
³⁰ University of Athens, Athens, Greece.
³¹ University of Manchester, Manchester, UK.
³² Pneumology Service, Hospital Universitario Lucus Augusti, Lugo, Spain.
³³ University of Sydney Medical School, Sydney, Australia.
³⁴ UK Severe Asthma Network, Barts Health NHS Trust and Queen Mary University of London, London, UK.
³⁵ University Hospital "Sv. Ivan Rilski", Sofia, Bulgaria.
³⁶ Bispebjerg Hospital, Copenhagen University, Copenhagen, Denmark.
³⁷ The Catholic University of Korea, Seoul, South Korea.
³⁸ Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, Canada.
³⁹ Division of Allergy & Clinical Immunology, Department of Medicine, National Jewish Health and Division of Allergy & Clinical Immunology, Department of Internal Medicine, University of Colorado Hospital, Denver and Aurora, CO, USA.
⁴⁰ Division of Pulmonary, Critical Care and Sleep Medicine, Asthma Program, National Jewish Health, Denver, USA.
⁴¹ Optimum Patient Care, Cambridge, UK. dprice@opri.sg.
⁴² Observational and Pragmatic Research Institute, Singapore, Singapore. dprice@opri.sg.
⁴³ Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK. dprice@opri.sg.

PMID: 32819285
PMCID: PMC7439682
DOI: 10.1186/s12874-020-01065-0

International severe asthma registry (ISAR): protocol for a global registry

J Mark FitzGerald et al. BMC Med Res Methodol. 2020.

. 2020 Aug 14;20(1):212.

doi: 10.1186/s12874-020-01065-0.

Authors

Affiliations

¹ The Institute for Heart Lung Health, Vancouver, Canada.
² AstraZeneca, Gaithersburg, USA.
³ Department of Pulmonary Medicine, University of Tartu and Lung Clinic, Tartu University Hospital, Tartu, Estonia.
⁴ Center of Physical Activity Research, Rigshospitalet and Copenhagen University, Copenhagen, Denmark.
⁵ Department of Respiratory Medicine & Allergology, Skåne University Hospital, Lund, Sweden.
⁶ Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
⁷ Department of Respiratory Diseases, Montpellier University Hospitals, Hopital Arnaud de Villeneuve and PhyMed Exp (INSERM U 1046, CNRS UMR9214), Universite de Montpellier, Montpellier, France.
⁸ Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
⁹ Departments of Epidemiology and Respiratory Medicine, Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands.
¹⁰ Optimum Patient Care, Cambridge, UK.
¹¹ Centre for Public Health, Queen's University Belfast, Belfast, UK.
¹² Personalized Medicine Asthma & Allergy Clinic, Humanitas University & Research Hospital, Milan, Italy.
¹³ SANI-Severe Asthma Network Italy, Milan, Italy.
¹⁴ Division of Allergy, Department of Medicine, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, South Korea.
¹⁵ Faculty of Public Health, Medical University - Sofia, Sofia, Bulgaria.
¹⁶ Son Espases University Hospital-IdISBa-Ciberes, Mallorca, Spain.
¹⁷ Clinical Research Centre, Smurfit Building Beaumont Hospital and Department of Respiratory Medicine, RCSI, Dublin, Ireland.
¹⁸ Australasian Severe Asthma Network, Priority Research Centre for Healthy Lungs, University of Newcastle, Newcastle, Australia.
¹⁹ Department of Respiratory and Sleep Medicine, Hunter Medical Research Institute, John Hunter Hospital, New Lambton Heights, Australia.
²⁰ Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.
²¹ Alfred Health & Monash University, Melbourne, Australia.
²² Department of Respiratory Medicine & Allergology, Faculty of Medicine, Kindai University Hospital, Ōsakasayama, Japan.
²³ Guy's & St Thomas' NHS Trust and King's College London, London, UK.
²⁴ Faculty of Medicine & Dentistry, University of Plymouth, Plymouth, UK.
²⁵ Department of Respiratory & Critical Care Medicine, Singapore General Hospital and Duke-National University Singapore Medical School, Singapore, Singapore.
²⁶ Allergy Centre, Tampere University Hospital and Tampere University, Tampere, Finland.
²⁷ Department of Respiratory Medicine, Faculty of Medicine, Landspitali University Hospital and University of Iceland, Reykjavik, Iceland.
²⁸ University of Amsterdam, Amsterdam, The Netherlands.
²⁹ Royal Brompton & Harefield NHS Foundation Trust, London, UK.
³⁰ University of Athens, Athens, Greece.
³¹ University of Manchester, Manchester, UK.
³² Pneumology Service, Hospital Universitario Lucus Augusti, Lugo, Spain.
³³ University of Sydney Medical School, Sydney, Australia.
³⁴ UK Severe Asthma Network, Barts Health NHS Trust and Queen Mary University of London, London, UK.
³⁵ University Hospital "Sv. Ivan Rilski", Sofia, Bulgaria.
³⁶ Bispebjerg Hospital, Copenhagen University, Copenhagen, Denmark.
³⁷ The Catholic University of Korea, Seoul, South Korea.
³⁸ Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, Canada.
³⁹ Division of Allergy & Clinical Immunology, Department of Medicine, National Jewish Health and Division of Allergy & Clinical Immunology, Department of Internal Medicine, University of Colorado Hospital, Denver and Aurora, CO, USA.
⁴⁰ Division of Pulmonary, Critical Care and Sleep Medicine, Asthma Program, National Jewish Health, Denver, USA.
⁴¹ Optimum Patient Care, Cambridge, UK. dprice@opri.sg.
⁴² Observational and Pragmatic Research Institute, Singapore, Singapore. dprice@opri.sg.
⁴³ Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK. dprice@opri.sg.

PMID: 32819285
PMCID: PMC7439682
DOI: 10.1186/s12874-020-01065-0

Abstract

Background: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi-country registry project initiated to aid in this endeavour.

Methods: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (≥18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR's collaborators include Optimum Patient Care, the Respiratory Effectiveness Group (REG) and AstraZeneca. ISAR is overseen by the ISC, REG, the Anonymised Data Ethics & Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders.

Conclusions: ISAR aims to offer a rich source of real-life data for scientific research to understand and improve disease burden, treatment patterns and patient outcomes in severe asthma. Furthermore, the registry will provide an international platform for research collaboration in respiratory medicine, with the overarching aim of improving primary and secondary care of adults with severe asthma globally.

Keywords: Disease registry; Protocol; Real-world; Severe asthma.

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Conflict of interest statement

AHM-vdZ declares unrestricted grants from GlaxoSmithKline, Novartis and Boehringer Ingelheim, personal fees for advisory board activities from AstraZeneca and a travel grant from Chiesi. AA has received lecture fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, MSD, Norameda, Novartis and Orion; sponsorships from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, MSD, Norameda and Novartis; and has been a member of advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis and Teva. AM-G declares grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Hoffman La Roche; consultancy agreements with AstraZeneca, Sanofi and Vectura; attendance at advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi and Teva; received speaker fees from AstraZeneca, Boehringer Ingelheim, Novartis, Teva and Vectura; and attended international conferences for Boehringer Ingelheim and Teva. AB has received speaker fees and grants to his institution from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline and Novartis for unrelated projects. CMP, DL, GC, JB, JMF, MS, RBM, TAP, TL, UB, VB and YSC have no relevant conflicts of interest. CKR declares consultancy and lecture fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, MSD, Mundipharma, Novartis, Sandoz, Takeda and Teva-Handok. CAP, IC, LB2, NE, NH and VC are employees of Optimum Patient Care, a co-funder of the International Severe Asthma Registry. DJJ has received advisory board and speaker fees from AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Teva, Napp Pharmaceuticals, Chiesi and Novartis and research grant funding from AstraZeneca. DBP declares board membership with Aerocrine, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Mundipharma, Napp Pharmaceuticals, Novartis and Teva; consultancy agreements with Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Napp Pharmaceuticals, Novartis, Pfizer, Teva and Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from Aerocrine, AKL Research and Development Ltd., AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Mylan, Mundipharma, Napp Pharmaceuticals, Novartis, Pfizer, Respiratory Effectiveness Group, Teva, Theravance, UK National Health Service and Zentiva; payment for lectures/speaking engagements from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Mundipharma, Novartis, Pfizer, Skyepharma and Teva; payment for manuscript preparation from Mundipharma and Teva; payment for the development of educational materials from Mundipharma and Novartis; payment for travel/accommodation/meeting expenses from Aerocrine, AstraZeneca, Boehringer Ingelheim, Mundipharma, Napp Pharmaceuticals, Novartis and Teva; funding for patient enrolment or completion of research from Chiesi, Novartis, Teva and Zentiva; stock/stock options from AKL Research and Development Ltd., which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd. (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd. (Singapore); and is a peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme and Health Technology Assessment. EH has been on advisory boards for Sanofi-Genzyme, GlaxoSmithKline, Novartis, Circassia and Nestlè Purina. EW has received advisory board fees from AstraZeneca. She has been an investigator on clinical trials sponsored by AstraZeneca, GlaxoSmithKline, Novartis, Teva and National Institute of Allergy and Infectious Diseases (NIAID), for which her institution has received funding. BGC reports personal fees and non-financial support from Novartis, grants and personal fees from AstraZeneca, Chiesi and Menarini; personal fees and non-financial support from Teva, grants from Boehringer Ingelheim and personal fees from Sanofi and Mundipharma, outside the submitted work. GWC has received research grants as well as lecture or advisory board fees from Menarini, Alk-Abello, Allergy Therapeutics, Anallergo, AstraZeneca, MedImmune, Boehringer Ingelheim, Chiesi Farmaceutici, Circassia, Danone, Faes, Genentech, Guidotti-Malesci, GlaxoSmithKline, Hal Allergy, Merck, MSD, Mundipharma, Novartis, Orion, Sanofi-Aventis, Sanofi, Genzyme/Regeneron, Stallergenes, UCB Pharma, Uriach Pharma, Teva, Thermo Fisher and Valeas. GB has received honoraria for lectures from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis and Teva. He is a member of advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi/Regeneron and Teva. JZ, MA and TNT are employees of AstraZeneca, a co-funder of the International Severe Asthma Registry. LL declares personal fees for consultancy and lectures from ALK, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mundipharma, Novartis, Orion Pharma, Sanofi and Teva. LB1 has (in the last three years) received lecture or advisory board fees from Alk-Abello, AstraZeneca, Boehringer, Chiesi, GlaxoSmithKline, Mundipharma, Novartis, Sanofi, Genzyme/Regeneron and Teva. LGH declares he has received grant funding, participated in advisory boards and given lectures at meetings supported by Amgen, AstraZeneca, Boehringer Ingelheim, Circassia, Hoffmann la Roche, GlaxoSmithKline, Novartis and Teva; he has taken part in asthma clinical trials sponsored by Boehringer Ingelheim, Hoffmann la Roche and GlaxoSmithKline, for which his institution received remuneration; and he is the Academic Lead for the Medical Research Council Stratified Medicine UK Consortium in Severe Asthma, which involves industrial partnerships with a number of pharmaceutical companies, including Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Hoffmann la Roche and Janssen. LP declares non-financial support, personal fees and grants from Teva; non-financial support and personal fees from Boehringer Ingelheim, Esteve, GlaxoSmithKline, Mundipharma and Novartis; personal fees and grants from AstraZeneca and Chiesi; personal fees from Sanofi and non-financial support from Menarini, outside the submitted work. MH declares grants and other advisory board fees (made to his institutional employer) from AstraZeneca, GlaxoSmithKline, Novartis and Seqirus for unrelated projects. MP declares personal fees and non-financial support from AstraZeneca and GlaxoSmithKline. MEW reports receiving consulting honoraria from AstraZeneca, Boehringer Ingelheim, Genentech, GlaxoSmithKline, Novartis, Regeneron, Sanofi and Teva. MSK has been a member of advisory boards for AstraZeneca, GlaxoSmithKline and Sanofi and has received honoraria from AstraZeneca, GlaxoSmithKline and Sanofi. NP declares speaker fees and grants to his institution from AstraZeneca, GlaxoSmithKline and Novartis for unrelated projects. PEP declares speaker fees and grants to his institution from AstraZeneca, GlaxoSmithKline and Novartis for unrelated projects. PG declares speaker fees and grants to his institution from AstraZeneca, GlaxoSmithKline and Novartis for unrelated projects. RWC has received honoraria for lectures from Aerogen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis and Teva. He is a member of advisory boards for GlaxoSmithKline and Novartis, has received grant support from GlaxoSmithKline and Aerogen and has patents in the use of acoustics in the diagnosis of lung disease, assessment of adherence and prediction of exacerbations. RJ declares grants from Novartis, GlaxoSmithKline and AstraZeneca; personal fees for consultancy and speaker fees or travel support from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Chiesi, Nutricia, OPRI and Pfizer. TI declares grants from Astellas, Boehringer Ingelheim, Daiichi-Sankyo, Kyorin, Meiji Seika Pharma and Teijin Pharma and lecture fees from Kyorin. YT declares honoraria from Kyorin Pharma and Teijin Pharma and research funding from Kyorin and Meiji Seika Pharma.

Figures

**Fig. 1**
Objectives of the International Severe Asthma Registry

**Fig. 2**
International Severe Asthma Registry governance. *ADEPT* Anonymised Data Ethics & Protocol Transparency, AZ AstraZeneca, *ISAR* International Severe Asthma Registry, *REG* Respiratory Effectiveness Group

**Fig. 3**
Steps involved in data collection, transfer and storage. *eCRF* electronic case report form, *EDC* electronic data capture, *ISAR* International Severe Asthma Registry, *OPC* Optimum Patient Care

**Fig. 4**
International Severe Asthma Registry electronic case report form (screenshot). *ATS* American Thoracic Society, *ERS* European Respiratory Society, *FEV1* forced expiratory volume in 1 second, *FVC* forced vital capacity, *NAEPP* National Asthma Education and Prevention Program

**Fig. 5**
International Severe Asthma Registry variables. ^aCollected by all participating registries. *GINA* Global Initiative for Asthma

**Fig. 6**
Current International Severe Asthma Registry snapshot^a. ^aSource: image created in-house. *UAE* United Arab Emirates, UK United Kingdom, *USA* United States of America

**Fig. 7**
Key strengths of the International Severe Asthma Registry. *ISAR* International Severe Asthma Registry

See this image and copyright information in PMC

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International severe asthma registry (ISAR): protocol for a global registry

Affiliations

International severe asthma registry (ISAR): protocol for a global registry

Authors

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Abstract

Conflict of interest statement

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