Factors associated with health status and exacerbations in COPD maintenance therapy with dry powder inhalers

Janwillem W. H. Kocks*, Hans Wouters, Sinthia Bosnic-Anticevich, Joyce van Cooten, Jaime Correia de Sousa, Biljana Cvetkovski, Richard Dekhuijzen, Lars Dijk, Evgeni Dvortsin, Marina Garcia Pardo, Asparuh Gardev, Radosław Gawlik, Iris van Geer - Postmus, Iris van der Ham, Marten Harbers, Alberto de la Hoz, Ymke Janse, Marjan Kerkhof, Federico Lavorini, Tiago MaricotoJiska Meijer, Boyd Metz, David Price, Miguel Roman-Rodriguez, Kirsten Schuttel, Nilouq Stoker, Ioanna Tsiligianni, Omar Usmani, Marika T. Leving

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Abstract

The study aimed to determine the associations of Peak Inspiratory Flow (PIF), inhalation technique and adherence with health status and exacerbations in participants with COPD using DPI maintenance therapy. This cross-sectional multi-country observational real-world study included COPD participants aged ≥40 years using a DPI for maintenance therapy. PIF was measured three times with the In-Check DIAL G16: (1) typical PIF at resistance of participant’s inhaler, (2) maximal PIF at resistance of participant’s inhaler, (3) maximal PIF at low resistance. Suboptimal PIF (sPIF) was defined as PIF lower than required for the device. Participants completed questionnaires on health status (Clinical COPD Questionnaire (CCQ)), adherence (Test of Adherence to Inhalers (TAI)) and exacerbations. Inhalation technique was assessed by standardised evaluation of video recordings. Complete data were available from 1434 participants (50.1% female, mean age 69.2 years). GOLD stage was available for 801 participants: GOLD stage I (23.6%), II (54.9%), III (17.4%) and IV (4.1%)). Of all participants, 29% had a sPIF, and 16% were shown able to generate an optimal PIF but failed to do so. sPIF was significantly associated with worse health status (0.226 (95% CI 0.107–0.346), worse units on CCQ; p = 0.001). The errors ‘teeth and lips sealed around mouthpiece’, ‘breathe in’, and ‘breathe out calmly after inhalation’ were related to health status. Adherence was not associated with health status. After correcting for multiple testing, no significant association was found with moderate or severe exacerbations in the last 12 months. To conclude, sPIF is associated with poorer health status. This study demonstrates the importance of PIF assessment in DPI inhalation therapy. Healthcare professionals should consider selecting appropriate inhalers in cases of sPIF.

Original languageEnglish
Article number18
Number of pages10
Journalnpj Primary Care Respiratory Medicine
Volume32
Issue number1
DOIs
Publication statusPublished - 26 May 2022

Bibliographical note

Funding Information:
J.K. reports grants, personal fees and non-financial support from AstraZeneca, GSK and Boehringer Ingelheim; grants and personal fees from Chiesi Pharmaceuticals and TEVA; grants from Mundipharma; personal fees from MSD and COVIS Pharma; and also holds 72.5% of shares in the General Practitioners Research Institute. H.W. has received grants from Boehringer Ingelheim, which is the financial and scientific partner of GPRI for the submitted study, and from AstraZeneca, Novartis and Chiesi for scientific projects in the area of COPD/asthma. S.B.-A. has received grants from TEVA, and personal fees from TEVA, Boehringer Ingelheim, AstraZeneca, GSK, Sanofi and Mylan. J.C.d.S. reports or personal fees from AstraZeneca, Bial, Boehringer Ingelheim, GSK, Medinfar, Mundipharma and Sanofi. B.C. received honorarium from GSK and Sanofi. J.v.C., L.D., I.v.G.-P., I.v.d.H., Y.J., M.K., B.M., K.S., N.S., M.H., B.M. and M.T.L. were employed by General Practitioners Research Institute (GPRI) at the time of the study. In the past three years (2019–2021), GPRI conducted investigator- and sponsor-initiated research funded by non-commercial organizations, academic institutes, and pharmaceutical companies (including AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Mundipharma, Novartis, and Teva). R.D. has received grants and personal fees from TEVA, Boehringer Ingelheim, AstraZeneca, GSK, Chiesi, Focus Care, and Glenmark. R.G. has received personal fees from AstraZeneca, GSK and Chiesi. E.D. holds 27.5% of shares in the General Practitioners Research Institute. M.G.P. receives grants from AstraZeneca, GSK and Boehringer Ingelheim. A.G. and A.d.l.H. are employees of Boehringer Ingelheim. F.L. received grants and personal fees from GSK, personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Menarini International, Novartis, Orion, and Trudell International, outside the submitted work. T.M. is an Assoicate Editor at npj Primary Care Respiratory Medicine. J.M. received grants from Boehringer Ingelheim, during the conduct of the study; and grants from AstraZeneca, Chiesi, Novartis, and GSK, outside the submitted work. D.P. reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Theravance and Zentiva (Sanofi Generics); grants from the British Lung Foundation, Respiratory Effectiveness Group, UK National Health Service, and AKL Research and Development Ltd; personal fees from Cipla, GlaxoSmithKline, Kyorin, Merck, Mundipharma, Airway Vista Secretariat, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, and WebMD Global LLC; non-financial support from Efficacy and Mechanism Evaluation programme and Health Technology Assessment; 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 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and 5% shareholding in Timestamp, which develops adherence monitoring technology. M.R.-R. receives grants and personal fees from AstraZeneca and GSK; and personal fees from Boehringer Ingelheim, Chiesi, Menarini, Mundipharma, Novartis, Pfizer, TEVA and BIAL. I.T. reports grants and personal fees from GSK, AstraZeneca, Boehringer Ingelheim, Menarini, Novartis, Chiesi and Elpen. O.U. reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Edmond Pharma, Chiesi and GSK; grants from Edmond Pharma; and personal fees from Napp, Mundipharma, Sandoz, Takeda, Cipla, COVIS, Novartis, Mereobiopharma, Orion, and Menarini. S.B.-A. and T.M. are Associate Editors at npj Primary Care Respiratory Medicine, and I.T. is Editor in Chief. These authors were not involved in the journal’s review of, or decisions related to, this manuscript.

Data Availability Statement

The data that support the findings of this study are available on request from the corresponding author J.K.
Code availability
The custom code that is deemed central to the findings and conclusion in this manuscript are available on request from the corresponding author J.K.

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