Evaluation of inhalation technique in patients using Dry Powder Inhaler (DPI), and the effect of patient education on their techniques- an experience from Nepal

Abstract Background Inhaler selection is important when managing respiratory conditions; a patient’s inhalation technique should be appropriate for the selected device, and patients should ideally be able to use a device successfully regardless of disease severity. The NEXThaler is a multidose dry-powder inhaler with a breath-actuated mechanism (BAM) and dose counter that activates only following inhalation, so effectively an ‘inhalation counter’. We assessed inspiratory flow through the NEXThaler in two studies and examined whether inhalation triggered the BAM. Methods The two studies were open-label, single-arm, and single visit. One study recruited patients with asthma aged ≥ 18 years; the other recruited patients with chronic obstructive pulmonary disease (COPD) aged ≥ 40 years. All patients inhaled twice through a placebo NEXThaler. The inspiratory profile through the device was assessed for each inhalation using acoustic monitoring, with flow at and time to BAM firing, peak inspiratory flow (PIF), and total inhalation time assessed. Results A total of 40 patients were enrolled in the asthma study: 20 with controlled asthma and 20 with partly controlled/uncontrolled asthma. All patients were able to trigger the BAM, as evidenced by the inhalation counter activating on closing the device. Mean flow at BAM firing following first inhalation was 35.0 (range 16.3–52.3) L/min; mean PIF was 64.6 (35.0–123.9) L/min. A total of 72 patients were enrolled in the COPD study, with data analysed for 69 (mean forced expiratory volume in 1 s 48.7% predicted [17–92%]). As with the asthma study, all patients, regardless of airflow limitation, were able to trigger the BAM. Mean flow at BAM firing following first inhalation was 41.9 (26.6–57.1) L/min; mean PIF was 68.0 (31.5–125.4) L/min. Device usability was rated highly in both studies, with 5 min sufficient to train the patients, and a click heard shortly after inhalation in all cases (providing feedback on BAM firing). Conclusions Inhalation flows triggering the BAM in the NEXThaler were similar between patients with controlled and partly controlled/uncontrolled asthma, and were similar across COPD airflow limitation. All enrolled patients were able to activate the device.

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Evaluation of inhalation technique in patients using a dry powder device (DPI) at chest clinic in Dhulikhel Hospital – Kathmandu University Hospital, and the effect of patient education on it

Clinical Medicine ◽

10.7861/clinmedicine.19-3s-s64 ◽

2019 ◽

Vol 19 (Suppl 3) ◽

pp. s64-s66

Author(s):

Sudeep Shrestha ◽

Sandhya Shrestha ◽

Maun Ranjan Baral ◽

Sambhawana Bhandari ◽

Swati Chand ◽

...

Keyword(s):

Patient Education ◽

University Hospital ◽

Inhalation Technique ◽

Dry Powder ◽

Chest Clinic

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Albuterol multidose dry powder inhaler efficacy and safety versus placebo in children with asthma

Allergy and Asthma Proceedings ◽

10.2500/aap.2016.37.4015 ◽

2016 ◽

Keyword(s):

Dry Powder Inhaler ◽

Efficacy And Safety ◽

Dry Powder ◽

Children With Asthma

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A generic fluticasone propionate and salmeterol dry powder inhaler: Evidence of usability, function, and robustness

Allergy and Asthma Proceedings ◽

10.2500/aap.2021.42.200112 ◽

2021 ◽

Vol 42 (1) ◽

pp. 30-35 ◽

Cited By ~ 1

Author(s):

Donald P. Tashkin ◽

Arkady Koltun ◽

Róisín Wallace

Keyword(s):

Chronic Obstructive Pulmonary Disease ◽

Fluticasone Propionate ◽

Healthy Volunteers ◽

Pulmonary Disease ◽

Dry Powder Inhaler ◽

Chemical Degradation ◽

Chronic Obstructive ◽

Dry Powder ◽

Obstructive Pulmonary Disease ◽

Flow Rates

Background: A generic combination of fluticasone propionate and salmeterol xinafoate inhalation powder in a premetered, multidose, nonreusable inhaler was recently approved. Objective: To assess the performance of the generic device. Methods: Findings from three studies with regard to device usability, function, and robustness were reviewed. Results: In a study to assess device function in patients and healthy volunteers, the generic device was successfully used by patients with asthma and chronic obstructive pulmonary disease who were either dry powder inhaler users or dry powder inhaler‐naive, even though they were not trained beyond being provided the instructions for use. In a study to measure inhaled flow rates generated by patients and healthy volunteers, the generic device consistently simulated the delivery of a full dose of drug, even to patients with severe respiratory disease and reduced inspiratory flow rates. Although the generic device had a slightly higher airflow resistance, this study demonstrated that this difference did not result in any clinically meaningful differences in terms of drug delivery. Pressure drop, a key parameter that drives the fluidization and aerosolization of the powder dose, was found to be comparable between the devices. In an open-label study, the generic device met all U.S. Food and Drug Administration specifications for device robustness after 21.5 days of twice-daily dosing via oral inhalation among 111 participants with asthma or chronic obstructive pulmonary disease. All inhalers tested demonstrated conformity with a pharmacopeia with respect to key quality parameters (assay, delivered dose uniformity, aerodynamic size distribution). There was no evidence of chemical degradation of the active ingredients, nor of microbial or water ingress into the powder, as a result of inhaler use.

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Study Evaluating 5 Doses of RPL554 and Placebo in COPD Patients Via a Dry Powder Inhaler

Case Medical Research ◽

10.31525/ct1-nct04027439 ◽

2019 ◽

Author(s):

Keyword(s):

Dry Powder Inhaler ◽

Dry Powder ◽

Copd Patients

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Flow and Particle Modelling of Dry Powder Inhalers: Methodologies, Recent Development and Emerging Applications

Pharmaceutics ◽

10.3390/pharmaceutics13020189 ◽

2021 ◽

Vol 13 (2) ◽

pp. 189

Author(s):

Zhanying Zheng ◽

Sharon Shui Yee Leung ◽

Raghvendra Gupta

Keyword(s):

Dry Powder Inhaler ◽

Research Direction ◽

Particle Methods ◽

Future Research ◽

High Dose ◽

Dry Powder ◽

Multi Scale ◽

Wide Range ◽

Computational Fluid Dynamics Cfd ◽

Discrete Element Methods

Dry powder inhaler (DPI) is a device used to deliver a drug in dry powder form to the lungs. A wide range of DPI products is currently available, with the choice of DPI device largely depending on the dose, dosing frequency and powder properties of formulations. Computational fluid dynamics (CFD), together with various particle motion modelling tools, such as discrete particle methods (DPM) and discrete element methods (DEM), have been increasingly used to optimise DPI design by revealing the details of flow patterns, particle trajectories, de-agglomerations and depositions within the device and the delivery paths. This review article focuses on the development of the modelling methodologies of flow and particle behaviours in DPI devices and their applications to device design in several emerging fields. Various modelling methods, including the most recent multi-scale approaches, are covered and the latest simulation studies of different devices are summarised and critically assessed. The potential and effectiveness of the modelling tools in optimising designs of emerging DPI devices are specifically discussed, such as those with the features of high-dose, pediatric patient compatibility and independency of patients’ inhalation manoeuvres. Lastly, we summarise the challenges that remain to be addressed in DPI-related fluid and particle modelling and provide our thoughts on future research direction in this field.

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