Expert Review of Respiratory Medicine ISSN: 1747-6348 (Print) 1747-6356 (Online) Journal homepage: https://www.tandfonline.com/loi/ierx20 Asthma patient satisfaction with different dry powder inhalers Antonio Valero, Paula Ribó, Luis Maíz, Esther Barbero, Myriam Calle, Carlos Campo, Paula Rytilä, Jordi Giner & Vicente Plaza To cite this article: Antonio Valero, Paula Ribó, Luis Maíz, Esther Barbero, Myriam Calle, Carlos Campo, Paula Rytilä, Jordi Giner & Vicente Plaza (2019) Asthma patient satisfaction with different dry powder inhalers, Expert Review of Respiratory Medicine, 13:2, 133-138, DOI: 10.1080/17476348.2019.1567339 To link to this article: https://doi.org/10.1080/17476348.2019.1567339 © 2019 The Author(s). Published by Informa View supplementary material UK Limited, trading as Taylor & Francis Group Published online: 21 Jan 2019. Submit your article to this journal Article views: 1094 View related articles View Crossmark data Citing articles: 4 View citing articles Full Terms & Conditions of access and use can be found at https://www.tandfonline.com/action/journalInformation?journalCode=ierx20 EXPERT REVIEW OF RESPIRATORY MEDICINE 2019, VOL. 13, NO. 2, 133–138 https://doi.org/10.1080/17476348.2019.1567339 ORIGINAL RESEARCH Asthma patient satisfaction with different dry powder inhalers Antonio Valeroa, Paula Ribóa, Luis Maízb, Esther Barberob, Myriam Callec, Carlos Campod, Paula Rytiläe, Jordi Ginerf and Vicente Plazaf a Servicio de Neumología y Alergia, Hospital Clínic. Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Centro de Investigaciones Biomédicas en Red de Enfermedades Respiratorias (CIBERES), Barcelona, Spain; bPneumology Department, Hospital Ramón y Cajal, Madrid, Spain; c Pulmonary Departament, Hospital Clínico San Carlos, Departament of Medicine, Faculty of Medicine, University Complutense of Madrid, Institute of Investigació Biomédica of Hospital Clínico San Carlos (IdISSC), Madrid, Spain; dOrion Pharma, Madrid, Spain; eOrion Corporation Orion Pharma, Espoo, Finland; fDepartment of Respiratory Medicine, Hospital de la Santa Creu i Sant Pau. Institut d’Investigació Biomédica Sant Pau (IIB Sant Pau), Centro de Investigaciones Biomédicas en Red de Enfermedades Respiratorias (CIBERES), Universitat Autònoma de Barcelona, Department of Medicine, Barcelona, Spain ABSTRACT ARTICLE HISTORY Background: The preferences and opinions of patients are important when choosing the optimal Received 19 July 2018 inhaler device for asthma management. We compared patient satisfaction of three dry powder inhalers Accepted 21 December 2018 in patients with moderate to severe asthma. KEYWORDS Methods: We selected a group of patients treated with EasyhalerTM (n = 164) and a second group of Asthma; dry powder inhaler; patients treated with TurbuhalerTM (n = 100) or DiskusTM (AccuhalerTM) (n = 64) from the register of an patient satisfaction; observational, multicenter study. Data of patients were paired according to age, gender, and asthma adherence severity. Patient satisfaction with the inhaler type was assessed with the specific ‘Feeling of Satisfaction with Inhaler’ (FSI-10) questionnaire. Results: Specific satisfaction with inhaler was statistically significantly higher with EasyhalerTM, as well as the percentage of patients with high satisfaction with inhaler. (FSI-10 score ≥43). Scores for EasyhalerTM were also statistically significantly better for individual FSI-10 items such as learning how to use, inhaler preparation, inhaler use, weight and size, and portability. There were no significant differences in asthma control (ACT, Mini-AQLQ) and adherence (TAI global score). Conclusions: Specific satisfaction with inhaler was higher with EasyhalerTM in a homogeneous popula- tion of patients with moderate to severe asthma. However, the relationship between satisfaction with the inhaler and adherence and asthma control deserves more investigation. 1. Introduction subpopulation of this study. Our objective was to compare EH and other DPIs regarding patient satisfaction with inha- When choosing asthma inhaled therapy, taking into account ler and potential clinical differences. the preferences and opinions of patients can improve adher- ence and asthma control [1,2]. Patient satisfaction with inhaler has been related to more favorable clinical outcomes [3], just 2. Materials and methods as difficulties using the inhaler have been shown to contribute The method used in the ASCONA (Asthma Satisfaction, to poor adherence [2]. Thus, inhaler choice is considered key CONtrol and Adherence) study has been previously reported for asthma control [4]. [9]. Briefly, the ASCONA scientific committee selected and Dry powder inhalers (DPIs) are used in asthma therapy invited the participating physicians. This selection aimed to [2]. However, they present different features that may have achieve an appropriate geographical distribution across clinical implications [5]. EasyhalerTM (EH) (Orion Corporation, Spain, as well as involving centers providing different levels Finland), is a three-step, light, compact, and user-friendly of healthcare. Seventy-three investigators (50.7% allergists DPI. It has advantages over older DPIs [6], including dose and 49.3% pulmonologists) participated in the study. They uniformity in different real-world conditions [7]. With regard selected 800 consecutive patients according to the inclusion to features such as perception of inhalation, size, discreet- criteria: age ≥ 18 years, physician-confirmed asthma diag- ness, mouthpiece comfort, and dose counter, EH was rated nosis, moderate to severe asthma according to GINA guide- higher than other inhaler devices by asthma patients [8]. In lines [2], and in receipt of any kind of asthma medication an observational, multicenter study, patient satisfaction with with the same inhaler for at least 3 months prior to their inhaler was higher in asthma patients treated with EH [9]. inclusion in the study. This last criterion was intended to Here we present a post-hoc analysis of a homogeneous assure that patients were under steady treatment without CONTACT Antonio Valero VALERO@clinic.cat Servicio de Neumología y Alergia, Hospital Clinic. Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Centro de Investigaciones Biomédicas en Red de Enfermedades Respiratorias (CIBERES), Barcelona, Spain Supplemental data for this article can be accessed here. © 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way. 134 A. VALERO ET AL. recent changes. Prior and current medications were regis- of patients with moderate asthma was higher in the EH tered and analyzed. Patients with disabling comorbidities group (p < 0.001). Therefore, we decided to perform a post- and/or cognitive dysfunction were excluded. All patients hoc analysis using two randomized paired samples of signed an informed consent form, no personal data were patients matched according to age, gender and asthma recorded, and neither physicians nor patients received any severity, and treated with EH or with TH/DKAH. To explore compensation for their participation. whether this EH differences were relevant or not, we cre- Physicians and patients completed electronic data collec- ated homogeneous groups using paired matched samples tion forms in a single visit. We recorded sociodemographic approach, which will provide enough statistical power by and clinical data, including age at asthma diagnosis and at unifying comparator groups (TH and AH) only under the therapy onset, current asthma therapy, and asthma severity assumption that they differ in a similar degree on the EH and control according to GINA [2]. We also included several results. questionnaires and tests. We assessed satisfaction with the specific Feeling of Satisfaction with Inhaler (FSI-10) ques- tionnaire [10] and the more general Treatment Satisfaction 2.1. Statistical analysis Questionnaire for Medication (TSQM) [11]. For adherence, Statistical analysis was performed with SPSS version 22.0 we used the Test of Adherence to Inhalers (TAI) to assess (SPSS Inc., Chicago, IL, USA). All statistical tests, tables and the specific adherence to inhalers [12] and the 4-item charts considered only the numbers of valid cases. Morisky-Green scale for the general adherence to treatment Categorical variables were described with number of (where 0 is no adherence and 4 is good adherence) [13]. We valid cases and percentage, whereas mean and standard also used the Asthma Control Test (ACT) [14] and the deviation (SD) were used for continuous variables. reduced version of the Asthma Quality of Life Dichotomous variables were created for each variable of Questionnaire (Mini-AQLQ) [15,16]. All these instruments interest using the median of the scores from the question- have been validated in Spanish [10,12,17–20]. Furthermore, naires and scales (FSI-10, TSQM, TAI and Mini-AQLQ) or FSI-10 and TAI have been developed in Spain. a pre-established cut-off point (ACT [22] and Morisky– The specific FSI-10 questionnaire assesses the portability Green scale [13]). and usability of inhalers regardless of administered drugs. Statistical tests included one-way analysis of variance Patients answer ten questions, each with five options, using (ANOVA) for group comparisons, Mann-Whitney test or a Likert scale from 5 (very) to 1 (hardly at all). The FSI-10 Kruskal–Wallis test for continuous variables, and χ2 test for maximum score is 50 (maximum satisfaction) [10] (see categorical variables. Pearson and Spearman correlation Supplementary file 1). tests were used to assess relationships between scale In turn, TAI consists of two complementary question- scores. Finally, multivariate analyses were performed to naires. The 10-item TAI is completed by the patient and examine factors that influenced the study dependent vari- identifies the level of adherence: good (50 points), inter- able (specific satisfaction with inhaler according to FSI-10). mediate (46–49 points), and poor (≤ 45 points). In turn, the 12-item TAI suggests the pattern of non-compliance. It includes the 10-item TAI plus two items that are answered 3. Results by the physician: knowledge of the dosing regimen by the We included a group of patients treated with EH (n = 164) patient (item #11) and performance of inhalation techni- and a second group of patients treated with TH (n = 100) or que without critical errors (item #12) [12] (see DKAH (n = 64). Data were paired by gender, age, and Supplementary file 2). asthma severity (Table 1). There were no statistically signifi- The study was conducted according to the Declaration of cant differences between groups in the forced expiratory Helsinki. The Clinical Research Ethics Committee of the volume in one second (FEV1) test (p = 0.443); daytime Hospital Clinic in Barcelona (Spain) approved its protocol. asthma symptoms more than twice/week (p = 0.664); The more common DPIs in the ASCONA register were EH, TurbuhalerTM (TH) (AstraZeneca, Sweden) or DiskusTM (AccuhalerTM) (DKAH) (GSK, United Kingdom). They also Table 1. Characteristics of study patients. were the only ones with an adequate number of patients TurbuhalerTM/ to perform statistical analyses. In a prior analysis of the EasyhalerTM DiskusTM (AccuhalerTM) (n = 164) (n = 164) ASCONA registry, study investigators included 739 patients N (%) or N (%) or with moderate or severe asthma treated with EH, TH or Variable mean ± SD mean ± SD p DKAH. The comparison between these three DPIs showed Socio-demographic and a significant trend favorable to EH when compared both clinical data versus TH and versus AH individually in specific satisfaction Age (y) 48.9 (16.16) 47.6 (15.9) ns Gender (female) 104 (63.4) 104 (63.4) 1 to inhaler, satisfaction with treatment, quality of life, and Age at asthma diagnosis (y) 32.7 ± 18.6 29.6 ± 18.8 ns asthma control [21] (see Supplementary file 3), without Age at onset of asthma 34,34 ± 18,18 31,4 ± 18,3 ns significant differences in other variables. However, because therapy (y) Asthma severity (GINA) 1 of non-systematic recruitment in the ASCONA registry, DPI Moderate 120 (73.2) 120 (73.2) groups were heterogeneous (in size and clinical profile) and Severe 44 (26.8) 44 (26.8) therefore not directly comparable. For instance, percentage ns, non-statistically significant; GINA, Global Initiative for Asthma. EXPERT REVIEW OF RESPIRATORY MEDICINE 135 night waking due to asthma (p = 0.861); need for rescue (p < 0.01). In addition, the percentage of patients with medication (p = 0.975); and activity limitation due to high satisfaction with treatment was statistically signifi- asthma (p = 0.823). No prior or current medication affected cantly higher in the EH group (p = 0.027). satisfaction with inhaler. In respect of specific adherence to inhaler (TAI), there was Table 2 shows the differences between groups in terms no statistically significant difference in TAI global scores of patient satisfaction and adherence. Specific satisfaction between groups. Nevertheless, mean scores of erratic and with the inhaler (global score of FSI-10) was statistically unwitting non-adherence patterns were higher in the EH significantly higher with EH compared with TH/DKAH group (p < 0.05 for both patterns), reflecting that these non- (p < 0.01). With regard to individual FSI-10 items, patients adherence patterns were less frequent with EH. There was no considered EH to be easier to learn to use (p = 0.025), statistically significant difference between groups for general easier to prepare for inhalation (p = 0.01), easier to use adherence in global scores of the Morisky–Green scale. (p = 0.012), and easier to carry (p = 0.018). Patients found With regard to asthma control, there was no statistically EH easier to continue with regular activities (p = 0.038), significant difference in ACT global score or in the percentage and its weight and size were more convenient (p < 0.001). of patients with controlled asthma (ACT score ≥ 20). Finally, In addition, = they felt they had used it correctly after there was no statistically significant difference in health- inhalation (p = 0.02). Overall, patients noted greater satis- related quality of life (Mini-AQLQ). faction with the device (p = 0.001). No statistically signifi- We performed a logistic regression analysis with specific cant difference was found for device cleaning and satisfaction with inhaler (FSI-10) as a dependent variable maintenance, or for mouthpiece comfort. Moreover, the (Figure 1). The most important factor leading to high satisfac- percentage of patients with high satisfaction with inhaler tion was the use of EH (odds ratio [OR] 1.705; 95% CI was statistically significantly higher with EH (p = 0.01). 1.056–2.755). Moreover, male gender slightly inclined towards Regarding general satisfaction with therapy (TSQM), high satisfaction with inhaler (OR 1.245; 95% CI 0.756–2.051). there were no statistically significant differences in global Conversely, factors that led to low satisfaction with inhaler scores between DPIs. However, patients in EH group were severe asthma (OR 1.186; 95% CI 0.663–2.120) and non- reported that it was easier to take their medication in its controlled asthma (OR 0.390; 95% CI 0.236 −0.643). current form (p = 0.018) and to plan when they will use the medication each time (p = 0.004). Patients using EH 4. Discussion also found it more convenient to take the medication as instructed (p = 0.042). Furthermore, all items of adverse In our real-world study, patient satisfaction with inhaler was event subscale showed a trend to be lower for EH group, higher with EH than with TH/DKAH. Among other features, but without statistical significance; this result is based on ease of use, convenient weight and size, and ease of portabil- questionnaire answers, not on patient-reported adverse ity contributed to higher satisfaction with EH. These results events of administered drugs. Moreover, convenience confirm the findings in the whole ASCONA population, where was statistically significantly higher in EH group patient satisfaction was also higher with EH than with TH or DKAH [9]. Moreover, although the aim of our study was not to prove the clinical relevance of differences in FSI-10 score, Table 2. Comparison of questionnaire results between groups. results of ASCONA main analysis [9] showed that these differ- TurbuhalerTM/ ences are clinically relevant. DiskusTM EasyhalerTM (AccuhalerTM) The preference for EH has been found in other studies in (n = 164) (n = 164) patients with asthma. Ahonen et al. [23] performed a meta- N (%) or N (%) or analysis of nine clinical trials (n = 802) of EH and metered- Variable mean ± SD mean ± SD p dose inhalers (MDIs) with and without a spacer, TH, and Specific satisfaction with inhaler (FSI-10) DiskhalerTM in patients with asthma. Ease of use was statis- FSI-10 score 43.8 ± 7.1 41.3 ± 7.6 < 0.01 High satisfaction (score ≥ 43) 92 (62.4) 68 (43) 0.01 tically significantly better for EH vs. the pooled data General satisfaction with medication (TSQM) (p < 0.001) and for almost all individual studies. Inhalation Effectiveness 71.4 ± 20.6 70.9 ± 18.4 ns Adverse events 97.1 ± 9.7 94.1 ± 14.3 < 0.05 through the device was also easier with EH, as was learning Convenience 79.7 ± 14.2 75.75 ± 16.1 < 0.01 how to use it. Patients preferred EH to the MDI and spacer Global satisfaction 74.6 ± 16.1 72.3 ± 17.7 ns (p < 0.001) and to TH (p < 0.01) [23]. Preference of patients High global satisfaction (score ≥ 75) 102 (63.4) 84 (51.2) < 0.05 Adherence for EH has also been shown in other randomized clinical TAI trials in patients with asthma. Jäger et al. [24] compared EH Score 47.1 ± 4.4 46.4 ± 5.1 ns and TH; almost 59% of patients preferred EH and scores of Good adherence (score ≥ 50) 64 (40.8) 59 (37.1) ns Non-adherence pattern device acceptability were higher for EH (p = 0.001). Erratic 23.1 ± 2.7 22.4 ± 3.4 < 0.05 Similarly, in a study by Tukiainen et al. [25] again 59% of Deliberate 24.1 ± 2.2 24.24 ± 2.2 ns Unwitting 3.9 ± 0.4 3.8 ± 0.4 < 0.05 patients preferred EH vs. TH. Moreover, overall acceptability Morisky-Green scale was higher for EH (p < 0.0001). In a study by Giner et al. [8], Score 3.1 ± 1.1 2.9 ± 1.1 ns nine aspects of the inhalers were rated from 0 to 10 for Good adherence (score = 4) 75 (45.1) 59 (36.0) ns each device. The overall score was higher for EH vs. TH ns, non-statistically significant; FSI-10, Feeling of Satisfaction with Inhaler ques- tionnaire; TSQM, Treatment Satisfaction Questionnaire for Medication; TAI, (p = 0.015) and vs. DKAH (p = 0.003). When patients were Test of the Adherence to Inhalers. asked to rank the inhalers in order of preference, EH was 136 A. VALERO ET AL. Figure 1. Binary logistic regression analysis using specific satisfaction with inhaler (FSI-10) as dependent variable. Use of EasyhalerTM led to high specific satisfaction with inhaler. placed first by 53% of patients, TH by 27% and DKAH by 5. Conclusions 20%. In two real-world multicenter studies by Gálffy et al. Physicians should keep in mind patient satisfaction with [26], patients considered that EH was easy to learn and use, asthma therapy, and especially specific satisfaction with and 95% were satisfied or very satisfied with this inhaler. the inhaler. In this setting, EH is well valued by patients. Erratic and unwitting non-adherence patterns were less In our homogeneous population of patients with moder- frequent in patients using EH. With respect to erratic non- ate to severe asthma, specific satisfaction with the inhaler adherence, we could not find a direct relationship was higher with EH. between forgetting to take the dose and the different However, the relationship between satisfaction with the inhaler devices. Regarding the lower unwitting non- inhaler and adherence and asthma control deserves more adherence with EH, we suggest that it was due to its investigation. ease of use, with only three steps and therefore fewer technical errors. There were no statistically significant dif- ferences between groups in terms of global adherence Key issues scores. Similarly, asthma control was comparable in both ● Physicians should keep in mind patient satisfaction with groups. A relationship between satisfaction and adherence asthma therapy, and especially specific satisfaction with has been found in other studies [3,27], but these did not the inhaler. compare different inhalers. In the main analysis of ● Dry powder inhalers (DPIs) present different features ASCONA, high patient satisfaction with inhaler was related that may have clinical implications. to adherence and asthma control [9]. However, because of ● EasyhalerTM has been shown to have advantages over the sample size in our subanalysis, the difference in satis- older DPIs in prior studies. faction was insufficient to be reflected in adherence and ● In a homogeneous population of patients with moder- asthma control. ate to severe asthma, specific satisfaction with inhaler The main strengths of our study are the population (measured with the FSI-10 questionnaire) was statisti- homogeneity and the use of validated and specific scales cally significantly higher with EasyhalerTM (43.8 ± 7.1) and questionnaires. Regarding potential limitations, adher- compared with TurbuhalerTM or DiskusTM (AccuhalerTM) ence was self-reported except for items 11 and 12 of TAI. (41.3 ± 7.6) (p < 0.01). However, these two physician-reported items define the ● Moreover, high satisfaction with inhaler was statistically unwitting non-adherence pattern. Another potential lim- significantly higher with EasyhalerTM (62.4% of patients) itation could be that different drug combinations may than with TurbuhalerTM or DiskusTM (AccuhalerTM) (43% affect results. of patients) (p = 0.01). EXPERT REVIEW OF RESPIRATORY MEDICINE 137 ● This preference for EH has been found in other studies in 4. Lavorini F, Levy ML, Dekhuijzen PR, et al. Inhaler choice and inhala- patients with asthma. tion technique: key factors for asthma control. Prim Care Respir J. 2009;18:241–242. 5. Chrystyn H, Price D. Not all asthma inhalers are the same: factors to Acknowledgments consider when prescribing an inhaler. Prim Care Respir J. 2009;18:243–249. Writing and editorial assistance was provided by Content Ed Net (Madrid, 6. Chrystyn H. Closer to an “Ideal Inhaler” with the Easyhaler®. Clin Spain). Drug Investig. 2006;26:175–183. 7. Haikarainen J, Rytilä P, Roos S, et al. Dose uniformity of budesonide Easyhaler® under simulated real-life conditions and with low Author contribution inspiration flow rates. Chron Respir Dis. 2018 ;15:265-271. 8. Giner J, Torrejón M, Ramos A, et al. Patient preference in the choice All authors have contributed significantly to conception, design and of dry powder inhalers. Arch Bronconeumol. 2004;40:106–109. execution of the study. All authors have participated in drafting, 9. Plaza V, Giner J, Calle M, et al. Impact of patient satisfaction with his reviewing, and/or revising the manuscript, and have approved its or her inhaler on adherence and asthma control. Allergy Asthma submission. Proc. 2018;39:437–444. •• It includes the method used in ASCONA study. 10. Perpiñá Tordera M, Viejo JL, Sanchis J, et al. [Assessment of patient Funding satisfaction and preferences with inhalers in asthma with the FSI-10 Questionnaire]. 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Concurrent and predictive M.C. has received speaker fees from Boehringer Ingelheim, validity of a self-reported measure of medication adherence. Med AstraZeneca, GlaxoSmithKline, Menarini, and Novartis, and has Care. 1986;24:67–74. received consulting fees from GlaxoSmithKline, Gebro Pharma and 14. Nathan RA, Sorkness CA, Kosinski M, et al. Development of the Novartis. asthma control test: a survey for assessing asthma control. J Allergy C.C. and P.R. are both employed by Orion Pharma. Clin Immunol. 2004;113:59–65. V.P. previously received honoraria for speaking at sponsored 15. Juniper EF, Buist AS, Cox FM, et al. Validation of a standardized meetings from AstraZeneca, Chiesi, GlaxoSmithKline and Novartis. version of the asthma quality of life questionnaire. Chest. They also received assistance in traveling to meetings from Chiesi 1999;115:1265–1270. and Novartis. They act as a consultant for ALK, AstraZeneca, 16. Juniper EF, Guyatt GH, Cox FM, et al. Development and validation Boehringer, MundiPharma and Sanofi. They have also received fund- of the mini asthma quality of life questionnaire. Eur Respir J. ing/grant support for research projects from a variety of government 1999;14:1044–1048. agencies and not-for-profit foundations, as well as AstraZeneca, 17. Trujols J, Iraurgi I, Siñol N, et al. Satisfaction with methadone as Chiesi and Menarini. a medication: psychometric properties of the Spanish version of The authors have no other relevant affiliations or financial invol- the treatment satisfaction questionnaire for medication. J Clin vement with any organization or entity with a financial interest in or Psychopharmacol. 2012;32:69–74. financial conflict with the subject matter or materials discussed in the 18. Val Jiménez A, Amorós Ballestero G, Martínez Visa P, et al. manuscript apart from those disclosed. 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