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 Maricoto; Jiska Meijer; Boyd Metz; David Price; Miguel Roman-Rodriguez; Kirsten Schuttel; Nilouq Stoker; Ioanna Tsiligianni; Omar Usmani; Marika T. Leving

doi:10.1038/s41533-022-00282-y

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 journal › Article › peer-review

2 Citations (Scopus)

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 language	English
Article number	18
Number of pages	10
Journal	npj Primary Care Respiratory Medicine
Volume	32
Issue number	1
DOIs	https://doi.org/10.1038/s41533-022-00282-y
Publication status	Published - 26 May 2022

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W. H. Kocks, J., Wouters, H., Bosnic-Anticevich, S., van Cooten, J., Correia de Sousa, J., Cvetkovski, B., Dekhuijzen, R., Dijk, L., Dvortsin, E., Garcia Pardo, M., Gardev, A., Gawlik, R., van Geer - Postmus, I., van der Ham, I., Harbers, M., de la Hoz, A., Janse, Y., Kerkhof, M., Lavorini, F., ... Leving, M. T. (2022). Factors associated with health status and exacerbations in COPD maintenance therapy with dry powder inhalers. npj Primary Care Respiratory Medicine, 32(1), [18]. https://doi.org/10.1038/s41533-022-00282-y

W. H. Kocks, J, Wouters, H, Bosnic-Anticevich, S, van Cooten, J, Correia de Sousa, J, Cvetkovski, B, Dekhuijzen, R, Dijk, L, Dvortsin, E, Garcia Pardo, M, Gardev, A, Gawlik, R, van Geer - Postmus, I, van der Ham, I, Harbers, M, de la Hoz, A, Janse, Y, Kerkhof, M, Lavorini, F, Maricoto, T, Meijer, J, Metz, B, Price, D, Roman-Rodriguez, M, Schuttel, K, Stoker, N, Tsiligianni, I, Usmani, O & Leving, MT 2022, 'Factors associated with health status and exacerbations in COPD maintenance therapy with dry powder inhalers', npj Primary Care Respiratory Medicine, vol. 32, no. 1, 18. https://doi.org/10.1038/s41533-022-00282-y

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title = "Factors associated with health status and exacerbations in COPD maintenance therapy with dry powder inhalers",

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{\textquoteright}s inhaler, (2) maximal PIF at resistance of participant{\textquoteright}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 {\textquoteleft}teeth and lips sealed around mouthpiece{\textquoteright}, {\textquoteleft}breathe in{\textquoteright}, and {\textquoteleft}breathe out calmly after inhalation{\textquoteright} 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.",

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

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{\textquoteright}s review of, or decisions related to, this manuscript. ",

year = "2022",

month = may,

day = "26",

doi = "10.1038/s41533-022-00282-y",

language = "English",

volume = "32",

journal = "npj Primary Care Respiratory Medicine",

issn = "2055-1010",

publisher = "Nature Publishing Group",

number = "1",

}

TY - JOUR

T1 - Factors associated with health status and exacerbations in COPD maintenance therapy with dry powder inhalers

AU - W. H. Kocks, Janwillem

AU - Wouters, Hans

AU - Bosnic-Anticevich, Sinthia

AU - van Cooten, Joyce

AU - Correia de Sousa, Jaime

AU - Cvetkovski, Biljana

AU - Dekhuijzen, Richard

AU - Dijk, Lars

AU - Dvortsin, Evgeni

AU - Garcia Pardo, Marina

AU - Gardev, Asparuh

AU - Gawlik, Radosław

AU - van Geer - Postmus, Iris

AU - van der Ham, Iris

AU - Harbers, Marten

AU - de la Hoz, Alberto

AU - Janse, Ymke

AU - Kerkhof, Marjan

AU - Lavorini, Federico

AU - Maricoto, Tiago

AU - Meijer, Jiska

AU - Metz, Boyd

AU - Price, David

AU - Roman-Rodriguez, Miguel

AU - Schuttel, Kirsten

AU - Stoker, Nilouq

AU - Tsiligianni, Ioanna

AU - Usmani, Omar

AU - Leving, Marika T.

N1 - 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.

PY - 2022/5/26

Y1 - 2022/5/26

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85130698707&partnerID=8YFLogxK

U2 - 10.1038/s41533-022-00282-y

DO - 10.1038/s41533-022-00282-y

M3 - Article

C2 - 35618739

AN - SCOPUS:85130698707

VL - 32

JO - npj Primary Care Respiratory Medicine

JF - npj Primary Care Respiratory Medicine

SN - 2055-1010

IS - 1

M1 - 18

ER -

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

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