Skip to main content
Top
Published in: Advances in Therapy 8/2018

Open Access 01-08-2018 | Original Research

Clinical Effectiveness of Budesonide/Formoterol Fumarate Easyhaler® for Patients with Poorly Controlled Obstructive Airway Disease: a Real-World Study of Patient-Reported Outcomes

Authors: Lilla Tamási, Maria Szilasi, Gabriella Gálffy

Published in: Advances in Therapy | Issue 8/2018

Login to get access

Abstract

Introduction

The effectiveness of inhaled therapies can be influenced by many factors, including the type of inhaler, which may have clinical implications. We report a real-world, multicenter, open-label, non-randomized, non-interventional study conducted by 200 pulmonologists across 200 centers in Hungary. The effectiveness of budesonide/formoterol inhalation therapy in daily clinical practice, delivered via the Bufomix Easyhaler®, was evaluated in patients with asthma, chronic obstructive pulmonary disease (COPD) and asthma-COPD overlap (ACO).

Methods

Effectiveness was assessed after 12 weeks of treatment by spirometry, the Asthma Control Test, mini-Asthma Quality of Life Questionnaire, COPD Assessment Test and modified Medical Research Council dyspnea scale. Patient satisfaction with the Bufomix Easyhaler® and physicians’ assessments (ease of use and time taken to learn the technique) were also assessed.

Results

A total of 1498 patients with obstructive airway disease were evaluated (asthma: n = 621; COPD: n = 778; ACO: n = 99), of whom 455 (30.4%) were newly diagnosed inhaler-naïve patients and 1043 (69.6%) were switching from other inhalers. Significant improvements in lung function, disease control and health-related quality of life measures (all p ≤ 0.002) were reported after 12 weeks of Bufomix Easyhaler® use. Improvements were observed in both inhaler-naïve patients and those who switched to a Bufomix Easyhaler® from other devices. After switching, 72.4% of patients regarded the Bufomix Easyhaler® as ‘very good’ and > 90.0% of physicians described the Bufomix Easyhaler® as easy to teach; 73.8% and 98.9% of patients learned the technique within 5 and 10 min of teaching, respectively.

Conclusion

Twelve weeks’ treatment with the Bufomix Easyhaler® resulted in significant improvements in disease control and quality of life. The Bufomix Easyhaler® was considered easy to use, and most patients were satisfied with the inhaler. Results confirm the real-world effectiveness of the Bufomix Easyhaler® in the treatment of adult outpatients with obstructive airway disease.

Funding

Orion Corp., Orion Pharma.
Appendix
Available only for authorised users
Literature
3.
go back to reference Müller V, Gálffy G, Orosz M, et al. Characteristics of reversible and nonreversible COPD and asthma and COPD overlap syndrome patients: an analysis of salbutamol Easyhaler data. Int J Chron Obstruct Pulmon Dis. 2016;11:93–101.PubMedPubMedCentral Müller V, Gálffy G, Orosz M, et al. Characteristics of reversible and nonreversible COPD and asthma and COPD overlap syndrome patients: an analysis of salbutamol Easyhaler data. Int J Chron Obstruct Pulmon Dis. 2016;11:93–101.PubMedPubMedCentral
4.
go back to reference Peters SP, Ferguson G, Deniz Y, Reisner C. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med. 2006;100(7):1139–51.CrossRefPubMed Peters SP, Ferguson G, Deniz Y, Reisner C. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med. 2006;100(7):1139–51.CrossRefPubMed
5.
go back to reference Pavord ID, Mathieson N, Scowcroft A, Pedersini R, Isherwood G, Price D. Author correction: the impact of poor asthma control among asthma patients treated with inhaled corticosteroids plus long-acting beta2-agonists in the United Kingdom: a cross-sectional analysis. NPJ Prim Care Respir Med. 2017;27(1):65.CrossRefPubMedPubMedCentral Pavord ID, Mathieson N, Scowcroft A, Pedersini R, Isherwood G, Price D. Author correction: the impact of poor asthma control among asthma patients treated with inhaled corticosteroids plus long-acting beta2-agonists in the United Kingdom: a cross-sectional analysis. NPJ Prim Care Respir Med. 2017;27(1):65.CrossRefPubMedPubMedCentral
6.
go back to reference Slejko JF, Ghushchyan VH, Sucher B, et al. Asthma control in the United States, 2008-2010: indicators of poor asthma control. J Allergy Clin Immunol. 2014;133(6):1579–87.CrossRefPubMed Slejko JF, Ghushchyan VH, Sucher B, et al. Asthma control in the United States, 2008-2010: indicators of poor asthma control. J Allergy Clin Immunol. 2014;133(6):1579–87.CrossRefPubMed
7.
go back to reference Price D, Fletcher M, van der Molen T. Asthma control and management in 8000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014;24:14009.CrossRefPubMedPubMedCentral Price D, Fletcher M, van der Molen T. Asthma control and management in 8000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014;24:14009.CrossRefPubMedPubMedCentral
10.
go back to reference Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management and prevention of chronic obstructive lung disease. http://goldcopd.org/. Accessed 12th April 2018. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management and prevention of chronic obstructive lung disease. http://​goldcopd.​org/​. Accessed 12th April 2018.
11.
go back to reference Pauwels RA, Löfdahl CG, Postma DS, et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. Formoterol and corticosteroids establishing therapy (FACET) international study group. N Engl J Med. 1997;337(20):1405–11.CrossRefPubMed Pauwels RA, Löfdahl CG, Postma DS, et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. Formoterol and corticosteroids establishing therapy (FACET) international study group. N Engl J Med. 1997;337(20):1405–11.CrossRefPubMed
12.
go back to reference Ferguson GT, Tashkin DP, Skärby T, et al. Effect of budesonide/formoterol pressurized metered-dose inhaler on exacerbations versus formoterol in chronic obstructive pulmonary disease: the 6-month, randomized RISE (Revealing the Impact of Symbicort in reducing Exacerbations in COPD) study. Respir Med. 2017;132:31–41.CrossRefPubMed Ferguson GT, Tashkin DP, Skärby T, et al. Effect of budesonide/formoterol pressurized metered-dose inhaler on exacerbations versus formoterol in chronic obstructive pulmonary disease: the 6-month, randomized RISE (Revealing the Impact of Symbicort in reducing Exacerbations in COPD) study. Respir Med. 2017;132:31–41.CrossRefPubMed
13.
go back to reference Laube BL, Janssens HM, de Jongh FH, et al. What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J. 2011;37(6):1308–31.CrossRefPubMed Laube BL, Janssens HM, de Jongh FH, et al. What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J. 2011;37(6):1308–31.CrossRefPubMed
14.
go back to reference Selroos O, Pietinalho A, Riska H. Delivery devices for inhaled asthma medication. Clinical implications of differences in effectiveness. BioDrugs. 1996;6:273–99. Selroos O, Pietinalho A, Riska H. Delivery devices for inhaled asthma medication. Clinical implications of differences in effectiveness. BioDrugs. 1996;6:273–99.
15.
go back to reference Lavorini F, Magnan A, Dubus JC, et al. Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD. Respir Med. 2008;102(4):593–604.CrossRefPubMed Lavorini F, Magnan A, Dubus JC, et al. Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD. Respir Med. 2008;102(4):593–604.CrossRefPubMed
16.
go back to reference Melani AS, Bonavia M, Cilenti V, et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011;105(6):930–8.CrossRefPubMed Melani AS, Bonavia M, Cilenti V, et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011;105(6):930–8.CrossRefPubMed
18.
go back to reference Malmberg LP, Everard ML, Haikarainen J, Lahelma S. Evaluation of in vitro and in vivo flow rate dependency of budesonide/formoterol Easyhaler((R)). J Aerosol Med Pulm Drug Deliv. 2014;27(5):329–40.CrossRefPubMedPubMedCentral Malmberg LP, Everard ML, Haikarainen J, Lahelma S. Evaluation of in vitro and in vivo flow rate dependency of budesonide/formoterol Easyhaler((R)). J Aerosol Med Pulm Drug Deliv. 2014;27(5):329–40.CrossRefPubMedPubMedCentral
20.
go back to reference Lähelmä S, Sairanen U, Haikarainen J, et al. Equivalent Lung dose and systemic exposure of budesonide/formoterol combination via easyhaler and turbuhaler. J Aerosol Med Pulm Drug Deliv. 2015;28(6):462–73.CrossRefPubMedPubMedCentral Lähelmä S, Sairanen U, Haikarainen J, et al. Equivalent Lung dose and systemic exposure of budesonide/formoterol combination via easyhaler and turbuhaler. J Aerosol Med Pulm Drug Deliv. 2015;28(6):462–73.CrossRefPubMedPubMedCentral
21.
go back to reference Lähelmä S, Vahteristo M, Metev H, et al. Equivalent bronchodilation with budesonide/formoterol combination via easyhaler and turbuhaler in patients with asthma. Respir Med. 2016;120:31–5.CrossRefPubMed Lähelmä S, Vahteristo M, Metev H, et al. Equivalent bronchodilation with budesonide/formoterol combination via easyhaler and turbuhaler in patients with asthma. Respir Med. 2016;120:31–5.CrossRefPubMed
22.
go back to reference Pirożyński M, Hantulik P, Almgren-Rachtan A, Chudek J. evaluation of the efficiency of single-inhaler combination therapy with budesonide/formoterol fumarate in patients with bronchial asthma in daily clinical practice. Adv Ther. 2017;34(12):2648–60.CrossRefPubMedPubMedCentral Pirożyński M, Hantulik P, Almgren-Rachtan A, Chudek J. evaluation of the efficiency of single-inhaler combination therapy with budesonide/formoterol fumarate in patients with bronchial asthma in daily clinical practice. Adv Ther. 2017;34(12):2648–60.CrossRefPubMedPubMedCentral
25.
go back to reference Thomas M, Kay S, Pike J, et al. The asthma control test (ACT) as a predictor of GINA guideline-defined asthma control: analysis of a multinational cross-sectional survey. Prim Care Respir J. 2009;18(1):41–9.CrossRefPubMed Thomas M, Kay S, Pike J, et al. The asthma control test (ACT) as a predictor of GINA guideline-defined asthma control: analysis of a multinational cross-sectional survey. Prim Care Respir J. 2009;18(1):41–9.CrossRefPubMed
26.
go back to reference Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the mini asthma quality of life questionnaire. Eur Respir J. 1999;14(1):32–8.CrossRefPubMed Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the mini asthma quality of life questionnaire. Eur Respir J. 1999;14(1):32–8.CrossRefPubMed
27.
go back to reference Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD assessment test. Eur Respir J. 2009;34(3):648–54.CrossRefPubMed Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD assessment test. Eur Respir J. 2009;34(3):648–54.CrossRefPubMed
28.
go back to reference Hsu KY, Lin JR, Lin MS, Chen W, Chen YJ, Yan YH. The modified medical research council dyspnoea scale is a good indicator of health-related quality of life in patients with chronic obstructive pulmonary disease. Singapore Med J. 2013;54(6):321–7.CrossRefPubMed Hsu KY, Lin JR, Lin MS, Chen W, Chen YJ, Yan YH. The modified medical research council dyspnoea scale is a good indicator of health-related quality of life in patients with chronic obstructive pulmonary disease. Singapore Med J. 2013;54(6):321–7.CrossRefPubMed
29.
go back to reference Hantulik P, Wittig K, Henschel Y, Ochse J, Vahteristo M, Rytila P. Usage and usability of one dry powder inhaler compared to other inhalers at therapy start: an open, non-interventional observational study in Poland and Germany. Pneumonol Alergol Pol. 2015;83(5):365–77.CrossRefPubMed Hantulik P, Wittig K, Henschel Y, Ochse J, Vahteristo M, Rytila P. Usage and usability of one dry powder inhaler compared to other inhalers at therapy start: an open, non-interventional observational study in Poland and Germany. Pneumonol Alergol Pol. 2015;83(5):365–77.CrossRefPubMed
30.
go back to reference Miller MR, Crapo R, Hankinson J, et al. General considerations for lung function testing. Eur Respir J. 2005;26(1):153–61.CrossRefPubMed Miller MR, Crapo R, Hankinson J, et al. General considerations for lung function testing. Eur Respir J. 2005;26(1):153–61.CrossRefPubMed
31.
go back to reference Miller MR, Hankinson J, Brusasco V, et al. Standardisation of spirometry. Eur Respir J. 2005;26(2):319–38.CrossRefPubMed Miller MR, Hankinson J, Brusasco V, et al. Standardisation of spirometry. Eur Respir J. 2005;26(2):319–38.CrossRefPubMed
32.
go back to reference Gälffy G, Mezei G, Németh G, et al. Inhaler competence and patient satisfaction with easyhaler(R): results of two real-life multicentre studies in asthma and COPD. Drugs R D. 2013;13(3):215–22.CrossRefPubMedPubMedCentral Gälffy G, Mezei G, Németh G, et al. Inhaler competence and patient satisfaction with easyhaler(R): results of two real-life multicentre studies in asthma and COPD. Drugs R D. 2013;13(3):215–22.CrossRefPubMedPubMedCentral
33.
go back to reference Rytilä PH, Syk J, Vinge I, Sörberg M. Switch from Symbicort Turbuhaler to Budesonide/Formoterol Easyhaler; a real-life prospective study in asthma patients. Orion Pharma. Data on file 2018. Abstract accepted for presentation at the European Respiratory Society Meeting, to be published in a supplement of the European Respiratory Journal, September 2018. Rytilä PH, Syk J, Vinge I, Sörberg M. Switch from Symbicort Turbuhaler to Budesonide/Formoterol Easyhaler; a real-life prospective study in asthma patients. Orion Pharma. Data on file 2018. Abstract accepted for presentation at the European Respiratory Society Meeting, to be published in a supplement of the European Respiratory Journal, September 2018.
Metadata
Title
Clinical Effectiveness of Budesonide/Formoterol Fumarate Easyhaler® for Patients with Poorly Controlled Obstructive Airway Disease: a Real-World Study of Patient-Reported Outcomes
Authors
Lilla Tamási
Maria Szilasi
Gabriella Gálffy
Publication date
01-08-2018
Publisher
Springer Healthcare
Published in
Advances in Therapy / Issue 8/2018
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI
https://doi.org/10.1007/s12325-018-0753-6

Other articles of this Issue 8/2018

Advances in Therapy 8/2018 Go to the issue