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Article History

Received: 14 February 2018

Accepted: 29 May 2018

First Online: 28 June 2018

Ethics approval and consent to participate

: The study was performed in accordance with the International Conference on Harmonization Good Clinical Practice Consolidated Guideline (E6). Written informed consent was signed and dated by patients before all study-related procedures. The trial was approved by the National Research Ethics Service Committee East Midlands – Northampton (13/EM/0468) and by the UK Medicines and Healthcare Products Regulatory Agency (EudraCT 2013–004630-14) and registered on (NCT02570425). See Additional file : Supplementary Material for more information on study governance.

: David B. Price has board membership with Aerocrine, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Mundipharma, Napp, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme and Teva Pharmaceuticals; consultancy agreements with Almirall, 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 Observational and Pragmatic Research Institute Pte Ltd) from Aerocrine, AKL Research and Development Ltd., AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, 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 Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Skyepharma, 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 Aerocrine, AstraZeneca, Boehringer Ingelheim, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals; funding for patient enrolment 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 UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd. (Singapore); and is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment. Vicky Thomas has no competing interests to declare. Richard Dekhuijzen has received grants and personal fees from Chiesi, AstraZeneca, Teva, Mundipharma, and Boehringer Ingelheim; grants from GlaxoSmithKline; and personal fees from Sandoz and Zambon. All are unrelated to the present work. Sinthia Bosnic-Anticevich has received sponsorship to carry out studies, together with Board Membership, consultant agreements and honoraria for presentation, from several pharmaceutical companies that market inhaled products. These include AstraZeneca, GlaxoSmithKline, Meda, Mundipharma, and Teva. Research sponsorship has also been received from grant awarding bodies (Australian Research Council, The Commonwealth of Australia Department of Health and the National Health and Medical Research Council). Nicolas Roche reports grants and personal fees from BoehringerIngelheim, Novartis, and personal fees from Teva, GSK, AstraZeneca, Chiesi, Mundipharma, Cipla, Sanofi, Sandoz, 3 M, Pfizer, Zambon, outside the presented work. Federico Lavorini received fees for lectures and advisory board meetings from Astra Zeneca, Boehringer Ingelheim, Chiesi, Cipla, Menarini International, TEVA, Zentiva. Priyanka Raju is an employee of OPRI, which has conducted paid research in respiratory disease on behalf of the following organizations in the past 5 years: Aerocrine, AKL Research and Development Ltd., Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Orion, Takeda, Teva, Zentiva (a Sanofi company). Daryl Freeman has received speaking honoraria, support for conferences or consultant agreements with AstraZeneca, Chiesi, Mundipharma, and Pfizer. Carole Nicholls is an employee of OPRI, which has conducted paid research in respiratory disease on behalf of the following organizations in the past 5 years: Aerocrine, AKL Research and Development Ltd., Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Orion, Takeda, Teva, Zentiva (a Sanofi company). Iain Small has no competing interests to declare. Erika Sims was an employee of Research In Real Life at the time the study was conducted. Guilherme Safioti is an employee of Teva Pharmaceuticals. Janice Canvin was an employee of Teva Pharmaceuticals at the time the study was conducted. Henry Chrystyn has received sponsorship to carry out studies, together with Board Membership, consultant agreements and honoraria for presentation, from several pharmaceutical companies that market inhaled products. These include Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Innovata Biomed, Meda, Napp Pharmaceuticals, Mundipharma, NorPharma, Novartis, Orion, Sanofi, Teva, Truddell Medical International, UCB and Zentiva. Research sponsorship has also been received from grant awarding bodies (EPSRC and MRC). He is the owner of Inhalation Consultancy Ltd. and a consultant to the Observational and Pragmatic Research Institute Pte Ltd., Singapore.

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