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Randomized Controlled Trial
. 2024 Nov 27;25(8):274.
doi: 10.1208/s12249-024-02998-1.

User-Friendliness Evaluation of Handling pMDI with Various Add-on Devices in Asthmatic Patients

Ahmed M Abdelfattah  1 , Rania M Sarhan  2 , Yasmin M Madney  2 , Ahmed F Mady  3 , Mohamed E A Abdelrahim  2 , Hadeer S Harb  4
Affiliations
Randomized Controlled Trial

User-Friendliness Evaluation of Handling pMDI with Various Add-on Devices in Asthmatic Patients

Ahmed M Abdelfattah et al. AAPS PharmSciTech. .

Abstract

The objective of this study was to assess the use of pMDI alone and pMDI with different spacers in asthmatic patients and to identify any associations between errors in handling the device for the first time and the sessions needed to reach the correct handling method, considering patient demographics and clinical characteristics. A total of 150 Asthmatic patients were crossed over to handle pMDI alone and with add-on inhalable devices (Aerochamber plus, Tips Haler, Able, Dispozable and Aer-8) randomly, without receiving verbal or demonstrative instruction (baseline assessment). The assessment of the inhaler technique was performed using checklists that had been set beforehand. Subsequently, the proper utilization of the inhaler was exhibited, and the patient's inhaler usage was reassessed. The demonstration was repeated until an optimal technique was attained. The number of counselling attempts required to achieve successful management, together with patient demographics and clinical factors, were documented. The mean percentage of total errors at baseline shows that pMDI alone is significantly higher than pMDI attached to add-on devices (53.90 ± 9.71, 32.54 ± 13.93, 24.53 ± 14.93, 21.6 ± 14.48, 25.14 ± 10.99, 27.47 ± 10.28) for pMDI alone, Aerochamber plus, Tips Haler, Able, Dispozable and Aer-8 respectively at p < 0.01. Able and Tips Haler spacers are significantly lower than other spacers with pMDI and pMDI alone in terms of total sessions needed to attain the complete optimal handling technique at p < 0.01. Weak and very weak correlations were observed between the percentage of total errors at baseline and the total sessions with education years, Montreal Cognitive Assessment, and age as well as some demographics and clinical variables. Handling pMDI can be challenging however the introduction of spacers simplifies this procedure. Different spacers cannot be treated as a homogeneous group due to variations in handling techniques and ease of use. the Able spacer requires the fewest handling steps of any spacer and has the highest percentage of patients who can use it without assistance.

Keywords: PMDI; add-on devices; asthma; critical errors; handling; spacers.

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Conflict of interest statement

Declarations. Ethical Committee Approval: Ethical approval was obtained from the clinical research ethics committees of both Institutional Review Board “IRB”, Faculty of Medicine, Minia University (1184/06/2024) and the Research Ethical Committee of the Faculty of Pharmacy, Beni-Suef University (REC-H-PhBSU-23051). Informed Consent Statement: Written informed consent was obtained from all the participants in the study. Competing of Interest: The authors declare no competing interests.

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