Critical Steps: A Non-Interventional, Multicenter, Prospective, Observational Study on Critical Handling Errors with DPI Use, in Asthma and COPD Patients

Bouros, Demosthenes; Evangeliou, Mina

doi:10.4172/2161-105x.1000360

Cited by 8 publications

(6 citation statements)

References 27 publications

(42 reference statements)

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“…Although this more conservative power analysis was utilized, researchers sought to include a larger sample size in order to identify the differences between inhaler types. As such, this study highlights common administration issues with each inhaler type, and is consistent with previous studies [16,24,27]. This may be helpful when determining future medication therapies for patients.…”

Section: Strengthssupporting

confidence: 88%

Interventional, Quasi-Experimental Study of a Chronic Obstructive Pulmonary Disease Education Care Plan for Hospital Discharge

et al. 2021

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Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity, mortality, and reduced quality of life for patients. Proper use of inhaler devices is critical for effective drug delivery and prevention of COPD progression. The primary endpoint of this study was a mean percent increase in correct steps associated with inhaler technique after pharmacist education. The co-primary endpoint was a 25% increase in the proportion of patients correctly identifying the appropriate use of short-acting versus long-acting inhaler types. This was an interventional quasi-experimental study of patients hospitalized at a 491-bed tertiary academic medical center with a COPD exacerbation to assess a pharmacist-led COPD care plan. Eligible patients included general floor, adult patients admitted with a primary diagnosis of COPD exacerbation. The primary investigator recorded initial inhaler technique scores through a paper checklist, and provided education about device types and usage. Patients were reassessed within 48 h to determine if pharmacist education improved inhaler knowledge. A total of 67 patients received the COPD care plan before hospital discharge. At baseline, patients scored a median of 81.8% (67.5–97.0) of steps correct across all inhaler device types. After pharmacist education, patient scores increased to a median of 100% (90.9–100.0) (p < 0.0001). The proportion of patients correctly identifying when to use short-acting versus long-acting inhalers increased from 73.1% to 98.5% (p < 0.0001). Implementation of a pharmacist-led care plan for patients admitted for COPD exacerbation was associated with an increase in correct steps for appropriate inhaler technique and understanding of inhaler device types after pharmacist education.

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Section: Strengthssupporting

confidence: 88%

Interventional, Quasi-Experimental Study of a Chronic Obstructive Pulmonary Disease Education Care Plan for Hospital Discharge

et al. 2021

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“…Therefore, the results of high adherence that improves over time in the present observational study may be partly attributed to the appropriate use of the Elpenhaler device. To this end, it is also noteworthy that the Elpenhaler device, when compared with some other frequently used inhalation devices, exhibited the lowest error rates for critical errors in the inhalation maneuver [ 28 ]. Another important finding of that study is that physical demonstration of correct inhalation maneuvers prior to first administration leads to higher percentage of adequate use and minimization of critical errors [ 28 ].…”

Section: Discussionmentioning

confidence: 99%

“…To this end, it is also noteworthy that the Elpenhaler device, when compared with some other frequently used inhalation devices, exhibited the lowest error rates for critical errors in the inhalation maneuver [ 28 ]. Another important finding of that study is that physical demonstration of correct inhalation maneuvers prior to first administration leads to higher percentage of adequate use and minimization of critical errors [ 28 ]. Our results are in line with previously published data suggesting Elpenhaler as a ‘‘self-improvement’’ device [ 29 ].…”

Section: Discussionmentioning

confidence: 99%

Adherence and quality of life assessment in patients with asthma treatment with budesonide/formoterol via the Elpenhaler device: the COMPLETE study

Exarchos

Ρovina

Krommidas³

et al. 2022

BMC Pulm Med

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Background Asthma is a chronic inflammatory disease of the airways that causes recurring episodes of wheezing, breathlessness, chest tightness and coughing. Inhaled drugs on a daily basis are the cornerstone of asthma treatment, therefore, patient adherence is very important. Methods We performed a multicenter, open, non-interventional, observational, prospective study of 716 adult patients diagnosed with asthma receiving FDC (Fixed-dose combination) budesonide/formoterol via the Elpenhaler device. We assessed the adherence to treatment at 3 and 6 months (based on the MMAS-8: 8-item Morisky Medication Adherence Scale), the quality of life and change in forced expiratory volume in 1 s (FEV1) from baseline to follow-up. Results Approximately 80% of the patients showed medium to high adherence throughout the study. The mean (SD) MMAS-8 score at 6 months was 6.85 (1.54) and we observed a statistically significant shift of patients from the low adherence group to the high adherence group at 6 months. Moreover, after 6 months of treatment with FDC budesonide/formoterol, we observed an increase in the patients’ quality of life that as expressed by a change 2.01 (95%CI 1.93–2.10) units in Mini AQLQ (p < 0.0001) that was more pronounced in the high adherence group. The same trend was also observed in terms of spirometry (mean FEV1 2.58 L (0.85) at the end of the study, increased by 220 mL from baseline) with a higher improvement in the medium and high adherence groups. Conclusions Treatment with FDC of budesonide/formoterol via the Elpenhaler device was associated with improvement in asthma-related quality of life and lung function over 6 months that were more prominent in patients with higher adherence. Trial registration: 2017-HAL-EL-74 (ClinicalTrials.gov Identifier: NCT03300076).

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“…Patient satisfaction with the inhaler device is one of the factors affecting the adherence of patients to treatment. In this perspective, the role of the Elpenhaler® device has been evaluated in a Greek population diagnosed with COPD and asthma [28,29]. As far as adherence is concerned, the Elpenhaler®…”

Section: Discussionmentioning

confidence: 99%

Treatment Adherence and Health Status of Patients With COPD Under Treatment With Salmeterol/Fluticasone via the Elpenhaler® Device: The AHEAD Study

Exarchos,

Hillas,

Steiropoulos

et al. 2024

Clinical Respiratory J

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BackgroundChronic obstructive pulmonary disease (COPD) is a heterogeneous progressive lung condition characterized by long‐term respiratory symptoms and airflow limitation. Appropriate bronchodilation is the cornerstone of COPD treatment, leading to better health status as well as benefits in prognosis and mortality.MethodsIn the current open, noninterventional, observational study, 716 patients diagnosed with COPD of variable severity were administered a fixed‐dose combination (FDC) of fluticasone propionate and salmeterol (500 + 50 mcg) through the Elpenhaler® device. The patients' adherence to treatment (based on the MMAS‐8 [8‐item Morisky Medication Adherence Scale]) and health status (based on the CCQ [Clinical COPD Questionnaire]) were assessed at the beginning of the study and at the end of the 3‐month follow‐up period.ResultsThe mean ± SD MMAS‐8 score at 1 and 3 months was 6.12 ± 1.89 and 6.45 ± 1.80, respectively, indicating medium adherence overall; however, there was a statistically significant increase of 0.33 units in the MMAS‐8 score at the end of the follow‐up (paired t‐test p < 0.0001), suggestive of an improvement in adherence throughout the study. Higher adherence was associated with better health status at baseline, which further improved by the end of the follow‐up. Moreover, we observed a statistically significant decrease of 1.07 points (p < 0.0001) in the mean CCQ total score from the baseline (CCQ score = 2.2 ± 1.00) until the end of the study follow‐up (CCQ score = 1.13 ± 0.67). Similar conclusions were also drawn in the mean domain scores regarding symptoms (score equal to 1.36 ± 0.72, decrease by 1.18) as well as functional and mental state (scores equal to 0.86 ± 0.73 and 1.20 ± 0.88, decrease by 1.04 and 1.00, respectively, p < 0.0001). Similarly, when patients were stratified into subgroups with and without comorbidities, the former group showed an increase of 7% in the patients with medium to high adherence during the course of the study. In the same patient subgroup, there was a notable decrease in CCQ score by 1.18 points (p < 0.0001) during the study.ConclusionsThe administration of FDC of fluticasone propionate and salmeterol, (500 + 50 mcg) via the Elpenhaler® device for COPD, resulted in a well‐maintained or slight increase in treatment adherence and a subsequent benefit in health status, which further persisted after 3 months of treatment.

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Critical Steps: A Non-Interventional, Multicenter, Prospective, Observational Study on Critical Handling Errors with DPI Use, in Asthma and COPD Patients

Cited by 8 publications

References 27 publications

Interventional, Quasi-Experimental Study of a Chronic Obstructive Pulmonary Disease Education Care Plan for Hospital Discharge

Interventional, Quasi-Experimental Study of a Chronic Obstructive Pulmonary Disease Education Care Plan for Hospital Discharge

Adherence and quality of life assessment in patients with asthma treatment with budesonide/formoterol via the Elpenhaler device: the COMPLETE study

Treatment Adherence and Health Status of Patients With COPD Under Treatment With Salmeterol/Fluticasone via the Elpenhaler® Device: The AHEAD Study

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