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Article History

Received: 12 June 2019

Accepted: 8 August 2019

First Online: 21 August 2019

Ethics approval and consent to participate

: The study was registered under the established study database, namely, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance under the Registration Number EUPAS16891. Ethical approvals were obtained from the Anonymised Data Ethics & Protocol Transparency committee (ADEPT1017).

: Not applicable.

: DP reports grants and/or personal fees from Aerocrine, AKL Research and Development Ltd., Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, the British Lung Foundation, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Merck, Mylan, Mundipharma, Napp, Novartis, Pfizer, Regeneron Pharmaceuticals, the Respiratory Effectiveness Group, Sanofi Genzyme, Skyepharma, Teva, Theravance, the UK National Health Service, Zentiva (Sanofi Generics); non-financial support from Efficacy and Mechanism Evaluation Programme and Health Technology Assessment, outside the submitted work; stock/stock options from AKL Research and Development Ltd.; and owns 74% of the social enterprise Optimum Patient Care Ltd. (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd. (Singapore). SB reports grants and personal fees from TEVA, personal fees from Boehringer Ingelheim, AstraZeneca, Sanofi, and Mylan, outside the submitted work. IP has received speaker’s honoraria for speaking at sponsored meetings from AstraZeneca, Boehringer Ingelheim, Aerocrine, Almirall, Novartis, Teva, Chiesi, and GlaxoSmithKline, and payments for organising educational events from AstraZeneca and Teva. He has received honoraria for attending advisory panels with Genentech, Regeneron, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Teva, Merck, Sanofi, Circassia, Chiesi, and Knopp. He has received sponsorship to attend international scientific meetings from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Teva, and Chiesi. He has received a grant from Chiesi to support a phase 2 clinical trial in Oxford. NR reports grants and personal fees from Boehringer Ingelheim, Novartis, Pfizer and personal fees from Teva, GlaxoSmithKline, AstraZeneca, Chiesi, Mundipharma, Cipla, Sanofi, Sandoz, 3 M, and Zambon. DH reports personal fees and/or non-financial support from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, and Pfizer, outside the submitted work. LB has nothing to disclose. OU has received grants and/or personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Aerocrine, GlaxoSmithKline, Napp, Mundipharma, Sandoz, Prosonix, Takeda, Zentiva, Edmond Pharma, Cipla, and Pearl Therapeutics. GB reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Sanofi, and Teva, outside the submitted work. SWM reports other from Observational and Pragmatic Research Institute Pte Ltd. (OPRI), outside the submitted work. He was employed by the OPRI at the time the analyses were conducted; OPRI has conducted paid research in respiratory disease on behalf of the following organisations in the past 5 years: Anaxys, AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Circassia (formerly Aerocrine), GlaxoSmithKline, Harvey Walsh, Mapi, Morningside Healthcare, Mundipharma, Mylan (formerly Meda), Napp, Novartis, Orion, Plymouth University, Regeneron, Respiratory Effectiveness Group, Roche, Sanofi, Takeda, Teva, University of East Anglia, and Zentiva (a Sanofi company). SR was an employee of AstraZeneca at the time the analyses were conducted.