Inhaler personalisation based on peak inspiratory flow (PIF) among dry powder inhaler users: a pilot randomised control trial (RCT) in COPD.

IF 3.3 Q1 HEALTH POLICY & SERVICES Journal of Pharmaceutical Policy and Practice Pub Date : 2024-10-18 eCollection Date: 2024-01-01 DOI:10.1080/20523211.2024.2415425
Mas Fazlin Mohamad Jailaini, Jaya Muneswarao, Ching Zhen Hao, Rabia Hussain, Mohamed Faisal Abdul Hamid
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Abstract

Background: Dry powder inhalers (DPIs) are commonly used among patients with Chronic Obstructive Pulmonary Disease (COPD). These inhalers are breath-actuated, and require patients to generate sufficient peak inspiratory flow (PIF) to disaggregate the drug powder into respirable fine particles and deliver it to the lower airway tracts. Inhaler personalisation based on PIF among DPI users has not been studied in Malaysia, thus we conducted the present pilot study to determine the feasibility of conducting such research among COPD patients.

Methods: This was an open-label pilot randomised control trial, conducted from June 2021-January 2022 at the respiratory clinic of Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia. Measurement of PIF was performed with In-Check DIAL G16 among adult COPD patients treated with DPI and had suboptimal PIF. Eligible subjects were randomised using block randomisation into two groups, either the interventional group or the control group.

Results: Twenty-two COPD patients fulfilled the study criteria and were randomised to intervention (n = 11) and control (n = 11) groups. For the interventional group, there were statistically significant improvements between baseline and at 12 weeks for both FEV1 and CAT scores. The mean (% predicted) FEV1 were 54.6 ± 20.4% and 56.6 ± 19.8% (p = 0.026), pre-and post-intervention. The mean CAT score at baseline was 24.4 ± 5.8 and reduced to 19.6 ± 4.4 at 12 weeks (p = 0.012). For the control group, the mean (% predicted) FEV1 at baseline was 58.0 ± 21.9% and 56.5 ± 20.7% at 12 weeks, with no statistical significance difference (p = 0.143). However, there was a statistically significant difference in CAT scores at baseline and 12 weeks, with a mean of 26.5 ± 6.1 and 23.3 ± 5.6, respectively (p = 0.010).

Conclusion: The findings from the present pilot RCT highlighted that inhaler personalisation based on PIF among COPD patients was feasible and practical.

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基于干粉吸入器使用者吸入峰值流量 (PIF) 的个性化吸入器:慢性阻塞性肺病随机对照试验 (RCT)。
背景:干粉吸入器(DPI)是慢性阻塞性肺病(COPD)患者常用的吸入器。这些吸入器由呼吸驱动,需要患者产生足够的吸气峰值流量(PIF)才能将药粉分解成可吸入的细小颗粒,并将其输送到下气道。马来西亚尚未研究过根据吸入峰流速对使用干粉吸入器的患者进行吸入器个性化治疗,因此我们开展了本试验研究,以确定在慢性阻塞性肺病患者中开展此类研究的可行性:这是一项开放标签随机对照试验,于 2021 年 6 月至 2022 年 1 月在马来西亚国民大学 Canselor Tuanku Muhriz 医院呼吸科诊所进行。使用 In-Check DIAL G16 对接受 DPI 治疗且 PIF 不达标的成年慢性阻塞性肺病患者进行 PIF 测量。符合条件的受试者被随机分为两组,即干预组或对照组:22 名慢性阻塞性肺病患者符合研究标准,被随机分为干预组(11 人)和对照组(11 人)。干预组患者的 FEV1 和 CAT 评分在基线和 12 周后均有统计学意义上的显著改善。干预前后的 FEV1 平均值(预测百分比)分别为 54.6 ± 20.4% 和 56.6 ± 19.8% (p = 0.026)。基线时的平均 CAT 评分为 24.4 ± 5.8,12 周后降至 19.6 ± 4.4(p = 0.012)。对照组的 FEV1 基线平均值(预测百分比)为 58.0 ± 21.9%,12 周时为 56.5 ± 20.7%,差异无统计学意义(p = 0.143)。然而,基线和 12 周时的 CAT 评分差异有统计学意义,平均值分别为 26.5 ± 6.1 和 23.3 ± 5.6(p = 0.010):本试验性 RCT 的研究结果表明,基于 PIF 对慢性阻塞性肺病患者进行个性化吸入器治疗是可行的,也是切实可行的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Pharmaceutical Policy and Practice
Journal of Pharmaceutical Policy and Practice Health Professions-Pharmacy
CiteScore
4.70
自引率
9.50%
发文量
81
审稿时长
14 weeks
期刊最新文献
A quantitative investigation in a territory of Italy on citizens' attitudes towards medicines through the COVID-19 pandemic: the importance of possible indirect effects caused by the pandemic. Cost-effectiveness analysis of genotype-guided optimization of major depression treatment in Qatar. Exploring the influencing factors of adverse drug reaction reporting among medical personnel: a COM-B model-based study. Pharmacovigilance: the evolution of drug safety monitoring. Inhaler personalisation based on peak inspiratory flow (PIF) among dry powder inhaler users: a pilot randomised control trial (RCT) in COPD.
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