Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist

Dekhuijzen, P.N.R.; Corrigan, Chris J.; Hadfield, Ruth M.; Roche, Nicolas; Usmani, Omar; Barnes, Peter J.; Scullion, Jane; Lavorini, Federico; Corbetta, Lorenzo; Kocks, Janwillem; Cosío, Borja G.; Buhl, Roland; Pedersen, Søren

doi:10.1016/j.jaip.2022.03.013

Cited by 6 publications

(15 citation statements)

References 28 publications

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“…Bei der Auswahl des geeigneten Inhalationssystems sind sowohl die kognitiven und motorischen Fähigkeiten sowie die Umsetzung von Sprühstoßauslösung und Inhalationsmanöver als auch die Höhe des Inspirationsflusses zu berücksichtigen [175,176]. Patientenpräferenzen sind ebenso in die Entscheidung miteinzubeziehen [177].…”

Section: Medikamentöse Therapieunclassified

S2k-Leitlinie zur fachärztlichen Diagnostik und Therapie von Asthma 2023

et al. 2023

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ZusammenfassungDas Management von Asthma hat sich in den letzten Jahrzehnten fundamental gewandelt. Die vorliegende Leitlinie zur Diagnostik und Therapie von Asthma wurde für pneumologisch tätige Fachärztinnen und Fachärzte entwickelt, welche detaillierte und evidenzbasierte Informationen zu den neuen diagnostischen und therapeutischen Optionen von Asthma benötigen. Die Leitlinie zeigt die neue Bedeutung der Biomarker, insbesondere der Bluteosinophilen und des exhalierten NO (FeNO), in den diagnostischen Algorithmen von Asthma. Als erste Asthma-Leitlinie weltweit benennt die vorliegende Leitlinie die nachhaltige Symptomprävention und die Asthma-Remission als Asthma-Therapieziele, welche durch den Einsatz individuell angepasster, krankheitsmodifizierender Medikamente (wie inhalative Steroide, Allergenimmuntherapie oder Biologika) erreicht werden können. Die zentrale Bedeutung der Behandlung von typischen Asthma-Komorbiditäten wird zudem betont. Schließlich wird auch auf besondere Herausforderungen im Asthma-Management eingegangen, wie bspw. die Therapie von Asthma in der Schwangerschaft, die Behandlung von schwerem Asthma oder die Diagnostik und Therapie von arbeitsbedingten Asthma-Formen.

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Section: Medikamentöse Therapieunclassified

S2k-Leitlinie zur fachärztlichen Diagnostik und Therapie von Asthma 2023

et al. 2023

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“…It happens very often that the results do not meet the prespecified end points [ 172 ], so, in fact, only some of the solution studied in clinics will be transferred to everyday use. Furthermore, the results of the clinical study may be biased by inadequate use, since only 11.9% of studies provide reliable information on the training of patients to properly use inhaler devices properly [ 173 ]. To enhance the chances of different investigated formulations becoming real therapy methods and not only for the purpose of research for curiosity, sufficient communication between clinics and research institutes is required.…”

Section: Challenges and Future Perspectivesmentioning

confidence: 99%

Inhalable microparticles as drug delivery systems to the lungs in a dry powder formulations

Knap

Kwiecień

Reczyńska-Kolman

et al. 2022

Regenerative Biomaterials

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Inhalation-administrated drugs remain an interesting possibility of addressing pulmonary diseases. Direct drug delivery to the lungs allows one to obtain high concentration in the site of action with limited systemic distribution, leading to a more effective therapy with reduced required doses and side effects. On the other hand, there are several difficulties in obtaining a formulation that would meet all the criteria related to physicochemical, aerodynamic, and biological properties, which is the reason why only very few of the investigated systems can reach the clinical trial phase and proceed to everyday use as a result. Therefore, we focused on powders consisting of polysaccharides, lipids, proteins, or natural and synthetic polymers in the form of microparticles that are delivered by inhalation to the lungs as drug carriers. We summarized the most common trends in research today to provide the best dry powders in the right fraction for inhalation that would be able to release the drug before being removed by natural mechanisms. This review paper addresses the most common manufacturing methods with novel modifications, pros and cons of different materials, drug loading capacities with release profiles, and biological properties such as cytocompatibility, bactericidal, or anticancer properties.

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“…To acquire proficiency in handling inhalers, it is essential to provide proper training to patients (Poureslami et al, 2016;Dhadge et al, 2020;Luley et al, 2020;Rodrigues et al, 2021;Lindh et al, 2022;Sulku et al, 2022), since education on the proper use of inhalers is received by only a small number of them (Poureslami et al, 2016;Dekhuijzen et al, 2022). Furthermore, COPD clinical practice guidelines pay particular attention to proper advice and instruction on inhaler management as a vital part of treatment.…”

Section: Introductionmentioning

confidence: 99%

“…Chronic obstructive pulmonary disease (COPD) is among the significant health challenges worldwide ( Duarte-de-Araújo et al, 2019 ; Lindh et al, 2019 ) due to its high prevalence (11.7%) ( Padmanabhan et al, 2019 ), the high healthcare costs it leads to ( Barja-Martínez et al, 2019 ; Padmanabhan et al, 2019 ; Rincon-Montaña and Rosselli, 2019 ), and the negative effects it has on the quality of life ( Rincon-Montaña and Rosselli, 2019 ). The treatment relies primarily on inhaled medication ( Barja-Martínez et al, 2019 ; Duarte-de-Araújo et al, 2019 ; Padmanabhan et al, 2019 ) through currently available devices, which include dry powder inhalers (DPIs), metered-dose inhalers (MDIs), pressurized metered-dose inhalers (pMDIs), and soft mist inhalers (SMIs) ( Rincon-Montaña and Rosselli, 2019 ; Dekhuijzen et al, 2022 ; Lindh et al, 2022 ). These devices require many steps, which may be complex, making them difficult to use ( Melzer et al, 2017 ; Takaku et al, 2017 ; Dekhuijzen et al, 2022 ).…”

Section: Introductionmentioning

confidence: 99%

“…The treatment relies primarily on inhaled medication ( Barja-Martínez et al, 2019 ; Duarte-de-Araújo et al, 2019 ; Padmanabhan et al, 2019 ) through currently available devices, which include dry powder inhalers (DPIs), metered-dose inhalers (MDIs), pressurized metered-dose inhalers (pMDIs), and soft mist inhalers (SMIs) ( Rincon-Montaña and Rosselli, 2019 ; Dekhuijzen et al, 2022 ; Lindh et al, 2022 ). These devices require many steps, which may be complex, making them difficult to use ( Melzer et al, 2017 ; Takaku et al, 2017 ; Dekhuijzen et al, 2022 ). Therefore, the incorrect use of these devices becomes a major problem, leading to reduced therapeutic effects, increased symptoms, and ineffective disease control ( Vila Jato, 2020 ; Dekhuijzen et al, 2022 ).…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of an educational intervention about inhalation technique in healthcare professionals in primary care: a cluster randomized trial

Vázquez-González,

Leiva-Fernández,

Cotta-Luque

et al. 2023

Front. Pharmacol.

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Background: Incorrect inhalation technique (IT) is an important issue for chronic obstructive pulmonary disease (COPD) patients and healthcare professionals. Studies in which counseling is carried out with healthcare professionals beforehand so that they can properly educate their patients are required. The objective of the present trial is to assess the improvement in the performance of the IT in subjects with COPD and prescribed inhaled therapy after the implementation of an educational intervention conducted by their general practitioners.Methods: A cluster randomized clinical trial was conducted. A total of 286 COPD patients received scheduled inhalation therapy from 27 general practices in seven primary care centers. A teach-back educational intervention was implemented for both healthcare professionals and patients. The primary outcome of this study was the performance of the correct inhalation technique. It is considered a good technique if all steps in the inhalation data sheet are correctly performed. The secondary outcomes were assessed using forced spirometry, the basal dyspnea index, the Medical Research Council dyspnea scale, St George’s Respiratory Questionnaire (SGRQ), and EuroQoL5D-5L for health-related quality of life. A one-year follow-up was conducted using an intention-to-treat analysis.Results: After the intervention, incorrect IT was observed in 92% of professionals and patients, with rates reaching 50% and 69.2%, respectively. The effectiveness in patients was significant, with a number needed to treat of 2.14 (95% CI 1.79–2.66). Factors related to correct IT in patients included the type of intervention, length of intervention (>25 min), good pulmonary function, age (youngest <=65, oldest >83), and less limitation of activity due to dyspnea. There was no relation with the cluster.Conclusion: This study shows the effectiveness of direct inhaler technique training provided by a trained professional on an appropriate timescale (for example, a specific consultation for medication reviews), aiming to help subjects improve their performance using the teach-back method. This could be an encouraging intervention to improve medication adherence and health promotion in people with COPD.Clinical Trial Registration:clinicaltrials.gov, identifier ISRCTN93725230.

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Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist

Cited by 6 publications

References 28 publications

S2k-Leitlinie zur fachärztlichen Diagnostik und Therapie von Asthma 2023

S2k-Leitlinie zur fachärztlichen Diagnostik und Therapie von Asthma 2023

Inhalable microparticles as drug delivery systems to the lungs in a dry powder formulations

Effectiveness of an educational intervention about inhalation technique in healthcare professionals in primary care: a cluster randomized trial

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