EUROPEAN CLINICAL RESPIRATORY JOURNAL 2020, VOL. 8, 1833411 https://doi.org/10.1080/20018525.2020.1833411 Assessment of inhalation errors, training time and patient preference for DuoResp® Spiromax® and Symbicort® Turbuhaler® in patients with asthma and COPD Jordi Ginera, Marta Villarnovo Cerrillob, Jaime Aboín Sierrab, Laura Casas Herreroc, Oliver Patinod and Vicente Plazaa a Department of Respiratory Medicine, Hospital de la Santa Creu i Sant Pau. Institut d’Investigació Biomédica Sant Pau (IIB Sant Pau), Universitat Autónoma de Barcelona, Department of Medicine, Barcelona, Spain; bTeva Pharmaceuticals Spain, Madrid, Spain; cDynamic Science, Madrid, Spain; dTeva Pharmaceuticals, Amsterdam, The Netherlands ABSTRACT ARTICLE HISTORY While poor inhaler technique in asthma and chronic obstructive pulmonary disease (COPD) can Received 23 July 2019 compromise the effectiveness of inhaled medications, identifying and quantifying these errors Accepted 2 October 2020 may suggest ways to improve inhalation technique and patient outcomes. The objective of this KEYWORDS international, multicentre care improvement programme was to investigate errors in inhaler use Asthma; COPD; inhaler (handling errors and inhalation errors) made by patients in handling two dry powder inhalers; technique; inhaler error; DuoResp® Spiromax® and Symbicort® Turbuhaler®. Patients with asthma or COPD aged between adherence; DuoResp 18 and 80 years attending the allergology/pneumology departments of 14 hospitals in Spain and Spiromax; Symbicort Portugal were included. All assessments were performed during one regular scheduled visit to Turbuhaler; patient-reported the study clinic. Among 161 eligible patients (138 with asthma; 23 with COPD), inhalation errors outcome were the most common type of error, with no significant difference between devices in overall total error rate, handling error rate or inhalation error rate. Significantly fewer total errors per patient (1.4 vs. 1.9; p < 0.001) and handling errors per patient (0.5 vs. 0.8; p < 0.001) were observed with DuoResp® Spiromax® compared with Symbicort® Turbuhaler®. The mean number of attempts for patients using DuoResp® Spiromax® to perform two correct procedures was 1.9 (0.6) compared with 2.1 (0.9) attempts for patients using Symbicort® Turbuhaler® (p = 0.016). Compared with Symbicort® Turbuhaler®, DuoResp® Spiromax® was found to be easy to learn how to use (p < 0.001), easy to prepare (p < 0.001), easy to use (p < 0.001), comfortable in terms of weight and size (p = 0.001), and patients felt that they were using the device correctly (p < 0.001). Overall, 79.5% of patients stated that they preferred DuoResp® Spiromax® as their first option over Symbicort® Turbuhaler®. The findings of this study may be useful in developing effective inhaler training programmes and thus improve outcomes in asthma and COPD. Introduction technique [4,5,6,7,8]. In particular, correct inhaler tech­ nique can be compromised by a number of factors With an increasing prevalence since 1990 [1], both including patient age [9,10,11,12], level of training [9, asthma and chronic obstructive pulmonary disease 13, 14,15], gender [9] and educational level [9]. The (COPD) continue to impose a significant economic, design of the inhalation device itself can also impact on humanistic and clinical burden on patients, families the likelihood of patient error [15,16,17]. For this rea­ and healthcare systems [2,3,4,5]. Improved strategies son, various types of inhaler are available, each incor­ are needed to address the major public health problems porating specific features designed to make them more associated with asthma and COPD and to improve precise, practical and easy to use. outcomes for individual patients. DuoResp® Spiromax® and Symbicort® Turbuhaler® The recommended and accepted way of managing are two dry powder inhalers that are commonly avail­ asthma and COPD is through the use of inhaled med­ able to asthma and COPD patients. Symbicort® ications delivered via an appropriate inhaler device Turbuhaler® (AstraZeneca R&D, Lund, Sweden) was [4,5]. However, the effectiveness of inhaled medica­ one of the first metered-dose powder delivery systems tions can be substantially diminished by poor inhaler to be developed [18], and was created to deliver an CONTACT Jordi Giner Donaire jginer@santpau.cat Department of Respiratory Medicine, Hospital de la Santa Creu i Sant Pau, Barcelona 08025, Spain Supplemental data for this article can be accessed here. © 2020 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 License (http://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 2 J. GINER ET AL. inhaled corticosteroid (ICS; budesonide) and a long- or COPD aged between 18 and 80 years attending the acting β2 agonist (LABA; formoterol fumarate dihy­ allergology/pneumology departments of 14 hospitals drate) with good deposition when sufficient inspiratory (10 in Spain and four in Portugal). Specific inclusion flow is achieved [17,19]. The more recently developed criteria were a diagnosis of asthma or COPD according DuoResp® Spiromax® (Teva Pharmaceutical Industries, to the Global Initiative for Asthma (GINA), Global Petach Tikva, Israel) was designed to deliver budeso­ Initiative for Obstructive Lung Disease (GOLD), or nide and formoterol with high-dose uniformity and any equivalent local guidelines including the Spanish maximum ease of use [20,21]. Asthma Management Guidelines [22] or Spanish Because errors in inhalation technique are typically COPD Guidelines (GesEPOC) [23]; eligibility for com­ evaluated in clinical practice by an observer only, with bined ICS/LABA; previous prescription for one of the no standardisation, the MasterScope® Inhalation inhalers being evaluated in the project (up to 6 months Manager tool was developed to improve rigor in this without using either of the inhalers was permitted). All regard and was utilised in the current study. patients voluntarily gave their informed consent. The The objective of the current study was to identify, study was conducted in accordance with the evaluate and quantify errors in inhaler use (including Declaration of Helsinki, the International Conference handling errors and inhalation errors) made by on Harmonisation of Technical Requirements for patients with asthma or COPD in handling DuoResp® Registration of Pharmaceuticals for Human Use and Spiromax® and Symbicort® Turbuhaler®. The findings Good Clinical Practice guidelines, and the ethics com­ of this study may then be used to correct these errors, mittee at each participating site. The study was classi­ train the patient and assess efficiency in the long-term fied as a post-authorisation study and is therefore not handling of both devices. included in a clinical trial registry. Materials and methods Study objectives Study design and population The primary objective of the study was to identify, This study was part of an international, multicentre evaluate and quantify inhaler errors (including errors care improvement programme in patients with asthma in handling and errors in inhalation) made by asthma Table 1. Study objectives and endpoints. Objective Endpoint Primary objective To identify, evaluate and quantify inhaler errors (including errors in handling and The nature and quantity of inhaler errors (including and endpoint errors in inhalation) made by asthma or COPD patients using the DuoResp® handling errors and inhalation errors) Spiromax® and Symbicort® Turbuhaler® devices Secondary To assess frequency of patients with at least one handling error in specified Mean number of patients with ≥1 handling error in objectives and subpopulations the following subpopulations: endpoints ● Age ● Asthma/COPD ● Presence of dexterity problems To compare time spent with each device Time taken to use DuoResp® Spiromax® vs. time taken to use Symbicort® Turbuhaler® To compare inhalation technique parameters between DuoResp® Spiromax® and Analysis of: Symbicort® Turbuhaler® ● PIF ● Vin ● PIF1.5 ● mPIF ● Ti30 ● PEF To evaluate patient-reported outcomes Analysis of patient response across the following domains: ● Easy to learn how to use ● Easy to prepare ● Easy to use ● Comfortably adapts to the lips ● Comfortable in terms of weight and size ● Feeling of using the device correctly To evaluate patient preference Scoring system of 1 to 2 points to indicate the order of priority (2 = first choice; 1 = second choice) COPD: chronic obstructive pulmonary disease; PEF: peak expiratory flow; mPIF: maximal peak inspiratory flow; PIF: peak inspiratory flow; PIF1.5: peak inspiratory flow at 1.5 s of inhalation; Ti30: inhalation time after reaching 30 l/min; Vin: inhalation volume. EUROPEAN CLINICAL RESPIRATORY JOURNAL 3 or COPD patients using the DuoResp® Spiromax® and Symbicort® Turbuhaler® error questions referred speci­ Symbicort® Turbuhaler® devices. Handling errors were fically to errors in inhalation technique (Table 2). The defined on the basis of the information in the approved percentage of inhalation errors was calculated for each Patient Information Leaflets for each of the devices. device as described above for total errors. Study objectives and endpoints are listed in Table 1. Time spent with each device Three separate measures of the time spent with each Study assessments device were recorded. Time 1 was the time that the All assessments were performed during one visit to the patient took to read the instructions and perform the study clinic, which was scheduled according to the technique; Time 2 was the time spent by the healthcare normal clinical practice of each participating centre. professional (HCP) on the training process; and Time 3 At this visit, sociodemographic and clinical data were was the time spent performing at least two correct recorded, handling and inhalation tests were per­ inhalation manoeuvres with the Inhalation Manager. formed for both devices and questions were asked about the participant’s experience with each device, as Inhalation technique described below. Inhalation parameters, comprising peak inspiratory flow at 1.5 s of inhalation (PIF1.5), final peak inspira­ Error rates tory flow (PIF), inhalation volume, initial flow accel­ Total error rate. The patient was provided with one of eration, inhalation time after reaching 30 l/min (Ti30) the inhalers, and was asked to read the accompanying and peak expiratory flow (PEF) were measured during instructions. The patient was then asked to perform an the study visit using the MasterScope® Inhalation inhalation using a demonstration device, and any cri­ Manager tool. The necessary inhalation manoeuvres tical errors were recorded by the investigator. The same were recorded until the patient performed procedure was then carried out with the second device. a minimum of two correct manoeuvres. As more than Critical errors were recorded by the investigator one result for each assessment could be included for using a checklist of questions (Table 2). A total of 13 each inhaler, any given patient may have more than possible errors for DuoResp® Spiromax® and 17 possi­ one recorded reading per inhaler. ble errors for Symbicort® Turbuhaler® were included in the checklist. Patients were individually assessed on Patient-reported outcomes their use of the two devices against the full set of At the end of the study visit, patients were asked to questions. evaluate the two devices across the following The total number of possible errors for each device domains: 1) Easy to learn how to use; 2) Easy to was then calculated by multiplying the number of prepare; 3) Easy to use; 4) Comfortably adapts to the error-defining questions (13 or 17) by the number of lips; 5) Comfortable in terms of weight and size; 6) patients in the study. The overall total error rate for Feeling of using the device correctly. Each domain was each device was then calculated as follows: scored on a five-point Likert scale (1 = very; 2 = quite; 3 = somewhat; 4 = not very; 5 = not at all). Number of errors made by all participants ðcombinedÞ Patient preference for DuoResp® Spiromax® or Total number of possible errors Symbicort® Turbuhaler® inhalers was recorded using � 100% a scoring system of 1 to 2 points to indicate the order of priority (2 = first choice; 1 = second choice). Total number of errors was also stratified by age and diagnosis. Sample size calculation Handling error rate. Five of the 13 DuoResp® As the DuoResp® Spiromax® inhaler has only recently Spiromax® error questions and nine of the 17 been launched to market, real-world data relating to Symbicort® Turbuhaler® error questions referred speci­ errors made by patients when using the device are not fically to errors in inhaler handling (Table 2). The yet available. The sample size calculation was therefore handling error rate was calculated for each device as based on the work of Voshaar et al. [24] which com­ described above for total errors. pared the NEXThaler® with other dry powder inhalers such as Turbuhaler®. This approach is valid because the Inhalation error rate. Eight of the 13 DuoResp® NEXThaler® inhaler is similar to Spiromax® in that it is Spiromax® error questions and eight of the 17 easy to use in three steps (open, inhale and close). In 4 J. GINER ET AL. Table 2. Questions used to identify errors in the use of DuoResp® Spiromax® and Symbicort® Turbuhaler®. DuoResp® Spiromax® Symbicort® Turbuhaler® Answer indicating Answer indicating Question an error Question an error QUESTIONS RELATING TO HANDLING Does the patient remove or move the mouthpiece cap/open the inhaler No Does the patient remove the mouthpiece cap/open the inhaler correctly? No correctly until they hear a click? Does the patient shake the inhaler vigorously when the dose is being Yes Does the patient shake the inhaler vigorously when the dose is being prepared? Yes prepared? Does the patient shake the inhaler vigorously after preparing the dose? Yes Does the patient hold the inhaler in a vertical position (mouthpiece pointing upwards) while turning No the base when preparing the dose (45º)? Does the patient place the inhaler in their mouth and seal their lips No Does the patient prepare the dose correctly by turning the base until they hear a click? No around the mouthpiece? Does the patient close the device? No Does the patient prepare the dose correctly by returning it to its original position? No Does the patient hold the inhaler in a vertical position (mouthpiece pointing upwards) after turning No the base, until inhaling (45º)? Does the patient shake the device vigorously after preparing the dose? Yes Does the patient place the inhaler in their mouth and seal their lips around the mouthpiece? No Does the patient close the device? No QUESTIONS RELATING TO INHALATION Does the patient exhale slowly and empty their lungs? No Does the patient exhale slowly and empty their lungs? No Does the patient exhale inside the device before inhaling? Yes Does the patient exhale inside the device before inhaling? Yes Does the patient inhale as quickly/vigorously as possible? No Does the patient inhale as quickly/vigorously as possible? No Does the patient inhale strongly right from the beginning? No Does the patient inhale strongly right from the beginning? No Does the patient inhale through the mouthpiece? No Does the patient inhale through the mouthpiece? No Does the patient inhale through their nose? Yes Does the patient inhale through their nose? Yes Does the patient inhale as long as they possibly can? No Does the patient inhale as long as they possibly can? No Does the patient hold their breath (or hold it for more than 3 seconds)? No Does the patient hold their breath (or hold it for more than 3 seconds)? No EUROPEAN CLINICAL RESPIRATORY JOURNAL 5 Table 3. Baseline and demographic data. Characteristic Population (N = 161) Age, mean (SD) years 49.2 (17.5) Sex, n (%) Male 73 (45.3) Female 88 (54.7) Race, n (%) White 157 (97.5) Black 4 (2.5) Level of education, n (%) No education 4 (2.5) Primary education 59 (36.6) Secondary education 51 (31.7) Higher education 47 (29.2) Employment status, n (%) Employed 86 (53.4) Unemployed 15 (9.3) Retired 43 (26.7) Homemaker 17 (10.6) Diagnosis, n (%) Asthma 138 (85.7) COPD 23 (14.3) COPD: chronic obstructive pulmonary disease; SD: standard deviation. the Voshaar et al. study, 54% of patients did not com­ Version 18.0 of the Statistical Package for the Social mit any critical errors upon the first use of the Sciences (SPSS) software was used for all statistical NEXThaler® inhaler, compared with 30% with analyses. Turbuhaler®. It was conservatively assumed that the difference between the two devices in the current Primary endpoints study would be smaller than the 24 percentage-point The nature and characteristics of inhaler errors difference observed in the NEXThaler® reference study. (including handling errors and inhalation errors) was Thus, we estimated a difference of 9 percentage points described for both inhalers. Similar errors were sum­ between Spiromax® and Turbuhaler®. With this hypoth­ marised by type of mistake, and a categorical analysis esis, accepting an alpha risk of 0.05 for 80% accuracy in was performed of the frequency of prevalent handling a bilateral contrast and with a patient loss no greater errors for both inhalers. The frequencies were com­ than 5%, a required population sample of 509 patients pared using a Chi-squared test to assess the statistical was calculated. However, alternative scenarios utilising significance of the differences between devices. less conservative assumptions for the percentage-point difference indicated that statistical significance could Secondary endpoints be demonstrated with data from much smaller samples. The categorical analysis of prevalent handling errors For instance, with a difference of 16 percentage points, for both inhalers was stratified according to age, the required population sample would be 159 patients. asthma or COPD diagnosis, and the presence of dex­ With a still less conservative assumption of terity problems due to a history of arthritis, osteoar­ a percentage-point difference of 24, equivalent to that thritis, etc. The number of handling errors was between NEXThaler® and Turbuhaler®, only 69 patients presented for each of these categories, and were com­ would be needed to demonstrate significance. pared using a Chi-squared test to assess the statistical significance of the differences between devices. The categorical analyses of inhalation technique, Data analysis based on the assessed inhalation parameters: PIF1.5, Absolute and relative frequency distributions of quali­ final PIF, inhalation volume, initial flow acceleration, tative variables was prepared, as well as central trend Ti30 and PEF with DuoResp® Spiromax® and and dispersion measures (mean, standard deviation Symbicort® Turbuhaler® were stratified according to [SD], median, minimum and maximum) of quantita­ age and asthma or COPD diagnosis. The observed tive variables. 95% confidence intervals (CI) were cal­ parameters were compared using a Mann-Whitney- culated for the main quantitative variables of results Wilcoxon test to assess the statistical significance of associated with the primary objective and main sec­ the differences between devices. ondary variables. The mean time spent with each device was estimated Missing data were not imputed and were treated as and, using the Wilcoxon hypothesis test for differences lost. The subgroups defined in the protocol (age, between means, an assessment was made regarding comorbidities and social status) were analysed in line whether there were statistically significant differences with the analyses for the general population. between both devices. 6 J. GINER ET AL. Table 4. Total error rate, handling error rate and inhalation error rate for DuoResp® Spiromax® and Symbicort® Turbuhaler®. DuoResp® Spiromax® Symbicort® Turbuhaler® (n = 161) (n = 161) p value Total errors Number of questions 13 17 Number of possible errorsa 2093 2737 Number of errors observed 228 313 Error rate (total number of errors) 10.9% 11.4% 0.584 Handling errors Number of questions 5 9 Number of possible errorsa 805 1449 Number of errors observed 74 130 Error rate (handling errors) 9.2% 9.0% 0.921 Inhalation errors Number of questions 8 8 Number of possible errorsa 1288 1288 Number of errors observed 154 183 Error rate (inhalation errors) 12.0% 14.2% 0.101 a Calculated as (total number of questions) × 161 (total number of patients). The distribution of absolute and relative frequencies In total, 161 patients (54.7% female), with an overall of data collected using the 5-point Likert scale were mean (SD) age of 49.2 (17.5) years, were included in the study (Table 3). The majority (97.5%) were white, with a level of education ranging from primary educa­ tion only (36.6%), to secondary education (31.7%) and higher education (29.2%). Of the 161 evaluable patients, 138 (85.7%) were diagnosed with asthma and 23 (14.3%) with COPD. The mean (SD) length of time between initial diagnosis and entry into this study was 11.9 (13.2) years for asthma patients and 8.8 (10.4) years among COPD patients. Most patients (78.3%) were naïve to treatment with Symbicort® Turbuhaler® at the time of inclusion. No patients had prior experi­ ence with DuoResp® Spiromax® due to the recent com­ Figure 1. Error rates (total errors, handling errors, inhalation mercialisation of this device at the time the study was errors) for DuoResp® Spiromax® and Symbicort® Turbuhaler®. conducted. p = NS for DuoResp® Spiromax® and Symbicort® Turbuhaler® in all Sixty-seven (41.6%) patients had at least one comor­ cases bidity, with the most common coexisting conditions being hypertension (18 patients, 11.2%), dyslipidaemia (seven patients, 4.3%), hypercholesterolaemia (six prepared, and the statistical difference between both patients, 3.7%) and hypothyroidism (six patients, inhalers was compared using the McNemar test. 3.7%). Of 103 comorbidities overall, 95 were active at Descriptive statistics for patient preference findings the start of the study. Twenty-five patients (15.5%) are presented. were smokers at the start of the study, 52 (32.3%) were ex-smokers and 84 (52.2%) were non-smokers. Results Study population Error rates (total errors, handling errors and inhalation errors) At the time of database cut-off (31 March 2017), 175 patients had been enrolled at 14 hospitals in Spain and In terms of rates of errors made by the participants in Portugal. In total, 14 patients were excluded from the this study overall, inhalation errors were the most analysis for not meeting the selection criteria (two common type of error made with both devices (Table patients were >80 years of age, while for 12 patients, 4; Figure 1). There was no statistically significant dif­ <6 months had passed between the last time they used ference between DuoResp® Spiromax® and Symbicort® Symbicort® Turbuhaler® and their inclusion in the Turbuhaler® in terms of overall total error rate, hand­ study). ling error rate or inhalation error rate (Table 4). EUROPEAN CLINICAL RESPIRATORY JOURNAL 7 Symbicort® Turbuhaler® in patients with COPD (p = 0.081). Time spent with each device Mean time taken by patients to read the instructions and perform the technique (Time 1) was significantly longer with Symbicort® Turbuhaler® compared with DuoResp® Spiromax® (3.0 vs. 3.5 min; p < 0.001). Time spent by the HCP on the training process (Time 2) was also significantly longer with Symbicort® Figure 2. Patient-reported outcomes (patient responses to Turbuhaler® compared with DuoResp® Spiromax® (1.5 questions relating to the experience of using each device [%]). vs. 1.7 min; p = 0.023). There was no statistically S: DuoResp® Spiromax®; T: Symbicort® Turbuhaler®. significant difference in time spent performing at least two correct inhalation manoeuvres (Time 3) between In an analysis of mean errors per patient, signifi­ the two devices (2.2 vs. 2.5 min; p = 0.195). cantly fewer total errors per patient (1.4 vs. 1.9; p < 0.001) and significantly fewer handling errors per patient (0.5 vs. 0.8; p < 0.001) were observed with Inhalation technique DuoResp® Spiromax® compared with Symbicort® Turbuhaler®. There was no statistically significant dif­ Patients were assessed to determine their ability to ference in the mean number of inhalation errors per perform two independent correct inhalations. The patient between devices (1.0 for DuoResp® Spiromax® numbers of attempts for each correct inhalation were vs. 1.1 for Symbicort® Turbuhaler®; p = 0.107). recorded separately and then averaged. The mean number of attempts for patients using DuoResp® Spiromax® to perform two correct procedures was 1.9 (0.6) compared with 2.1 (0.9) attempts for patients Total number of errors stratified by age using Symbicort® Turbuhaler® (p = 0.016). A greater When the total number of errors made using each PIF1.5 (115.4 [37.8] vs. 105.3 [34.6] l/min; p < 0.001) device was stratified by age (Supplementary Table 1), and a greater final PIF was achieved with DuoResp® it was found that patients aged 41–65 years made fewer Spiromax® compared with Symbicort® Turbuhaler® errors on average with DuoResp® Spiromax® compared across all patients (116.3 [36.0] vs. 104.3 [35.9] l/min; with Symbicort® Turbuhaler® (mean 1.2 errors per p < 0.001). patient for DuoResp® Spiromax® vs. 1.7 for Symbicort® No difference between Symbicort® Turbuhaler® and Turbuhaler®; p = 0.038). A similar result was found for DuoResp® Spiromax® was observed in inhalation patients aged >65 years (mean 1.9 errors for DuoResp® volume, initial flow acceleration, Ti30 or PEF Spiromax® vs. 2.8 for Symbicort® Turbuhaler®; (p > 0.05 in all cases) (Supplementary Table 1). p = 0.007). There was no difference in the number of errors made with DuoResp® Spiromax® compared with Symbicort® Turbuhaler® in patients aged 18–40 years. Patient-reported outcomes Patient responses to questionnaires relating to the experience of using each device are presented in Figure Total number of errors stratified by diagnosis 2. Compared with Symbicort® Turbuhaler®, DuoResp® When the total number of errors made using each Spiromax® was found to be easy to learn how to use device was stratified by diagnosis (Supplementary (p < 0.001), easy to prepare (p < 0.001), easy to use Table 2), asthma patients made fewer errors on average (p < 0.001), comfortable in terms of weight and size with DuoResp® Spiromax® compared with Symbicort® (p = 0.001), and patients felt that they were using the Turbuhaler® (mean 1.3 errors per patient for DuoResp® device correctly (p < 0.001). Overall, 79.5% of patients Spiromax® vs. 1.8 for Symbicort® Turbuhaler®; stated that they preferred DuoResp® Spiromax® as their p = 0.001). There was no difference in the number of first option, while 20.5% (95% CI: 14.7–27.7) preferred errors made with DuoResp® Spiromax® compared with Symbicort® Turbuhaler® as their first choice. 8 J. GINER ET AL. Discussion Turbuhaler® (14.3%) versus those who had previously used Symbicort® Turbuhaler® (78.3%), which means This study showed that inhalation errors were the most that patients were bringing different levels of experi­ common type of error made with both devices, with no ence with this device to the study. A strength of this statistically significant difference between DuoResp® study is that all patients tested both devices, meaning Spiromax® and Symbicort® Turbuhaler® in overall total that they were able to compare devices directly through error rate, handling error rate or inhalation error rate. their own experience. However, the mean numbers of total errors (handling Although the effect of compromised dexterity on plus inhalation errors) and the mean number of hand­ handling errors was included as a secondary objec­ ling errors made by each patient, were lower with tive in this study (Table 1), it was not possible to DuoResp® Spiromax® compared with Symbicort® conduct this analysis because variables that define Turbuhaler®. In addition, 79.5% of patients in this this population were not captured in the case report study preferred DuoResp® Spiromax® as their inhaler form. of first choice, finding it easy to learn how to use, easy Finally, the results of this study may be skewed to prepare and to use and comfortable in terms of by fact that some patients had prior experience weight and size. Patients also felt confident that they with Symbicort® Turbuhaler® but were unlikely to were using the device correctly. have used DuoResp® Spiromax® because it only DuoResp® Spiromax® seemed particularly suited to became available in the region just before the older patients, with patients aged ≥41 years making start of this study. This discrepancy may have fewer errors with DuoResp® Spiromax® compared favoured Symbicort® Turbuhaler® as the most famil­ with Symbicort® Turbuhaler®. Patients with asthma iar device. made few device errors than those with COPD. Although we did not investigate the reasons for this Conclusion difference, it is likely to be because COPD patients are on average older than asthma patients, and therefore Inhalation errors were the most common type of error may be less manually dextrous [25,26]. made with both devices, with no statistically significant DuoResp® Spiromax® also performed better than difference between DuoResp® Spiromax® and Symbicort® Symbicort® Turbuhaler® in a number of other mea­ Turbuhaler® in the overall rate of errors made. However, sures, including a significantly shorter time required the number of total errors and handling errors per to use the device and statistically higher values for patient was lower with DuoResp® Spiromax® compared PIF1.5 and final PIF achieved. In addition, inhalation with Symbicort® Turbuhaler®. Overall, 79.5% of patients with DuoResp® Spiromax® needed to be repeated fewer in this study preferred DuoResp® Spiromax® over times in order to achieve a minimum of two correct Symbicort® Turbuhaler® as their first option, finding it procedures compared with Symbicort® Turbuhaler®. easy to learn how to use, easy to prepare and to use and Previous studies have indicated that implementation comfortable in terms of weight and size. of inhaler training achieves a measurable improvement in inhaler technique [27,28,29]. Multiple studies have shown that correct inhaler Acknowledgments technique leads to improved patient adherence and We thank Dynamic Science (Spain) for its participation in patient outcomes, and the importance of correct inha­ the project management, monitoring, data management and ler technique has been highlighted by GINA and statistical analysis of this study. GOLD [4,5,8,30,31]. Investigation and analysis of errors in the use of Funding inhalation devices in respiratory disease is therefore essential to allow these errors to be corrected This study was supported by Teva Pharmaceuticals Spain. through the implementation of training and educa­ Medical writing support, provided by Eleanor Coppins and Ian C. Grieve, PhD of Ashfield Healthcare Communications, tion strategies, and to ultimately improve patient part of UDG Healthcare plc, was funded by Teva outcomes. Pharmaceuticals. The current study has a number of limitations. First, the study population was very homogenous, although this reflects the population of the areas where the study Notes on contributors was conducted. In addition, there was a mix of patients Jordi Giner, RN, MsC in Respiratory Medicine, PhD. work­ who were naïve to treatment with Symbicort® ing in the Respiratory Medicine Service of the Santa Creu i EUROPEAN CLINICAL RESPIRATORY JOURNAL 9 Sant Pau Hospital in Barcelona (Spain); Author of the Funding Spanish Asthma Guide (GEMA); GEMA inhalers coordina­ tor; Coordinator of the Social Communication Committee of This study was supported by Teva Pharmaceuticals Spain. the Spanish Respiratory Society (SEPAR). Medical writing support, provided by Eleanor Coppins and Ian C. Grieve, PhD of Ashfield Healthcare Communications, Marta Villarnovo, BSc, MSc, PhD, is currently Medical part of UDG Healthcare plc, was funded by Teva Manager at Teva Pharma Spain. Before that she held several Pharmaceuticals. positions in the pharmaceutical industry. She earned her Master´s Degree in Biotechnology from International Business School Aliter, Madrid, Spain and her doctoral Data availability statement degree with the field of respiratory research at the University of A Coruña (Spain). The data that support the findings of this study are available from Teva Pharmaceuticals Spain upon reasonable request. Jaime Aboín Sierra, BSc, MSc, is currently Medical Manager Please contact Marta.VillarnovoCerrillo@tevaes.com with at Teva Pharma Spain. Before that he held several positions any enquiries. in the pharmaceutical industry. He earned his Master´s Degree in Biotechnology from International Business School Aliter, Madrid, Spain. References Laura Casas Herrero, BSc., is currently data analysis and biostatistician at the Clinical Research Organizations [1] GBD 2015 Chronic Respiratory Disease Collaborators. Dynamic for 10 years. Earlier she has worked as a biostatis­ Global, regional, and national deaths, prevalence, dis­ tician at the Clinical Research Organizations Biometrica. She ability-adjusted life years, and years lived with disability earned his Degree from Complutense University, Spain. for chronic obstructive pulmonary disease and asthma, 1990–2015: a systematic analysis for the global burden Oliver Patino, MPH, MA, is currently the Director of of disease study 2015. Lancet Respir Med. Scientific Communications and respiratory area lead of 2017;5:691–706. Teva Pharmaceuticals, Europe. He has held various positions [2] Asher I, Pearce N. Global burden of asthma among in the pharmaceutical industry in R&D and Medical Affairs children. Int J Tuberc Lung Dis. 2014;18: 1269–1278. for the last 20 years. Obtained his Master’s degree in Public [3] Ferkol T, Schraufnagel D. The global burden of respira­ Health at the Université Libre de Bruxelles (ULB), Brussels, tory disease. 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