Diskus Dry Powder Inhaler Research Articles

Automatic Audio-Based Classification of Patient Inhaler Use: A Pharmacy Based Study.

Chronic respiratory diseases may be controlled through the delivery of medication to the airways and lungs using an inhaler. However, adherence to correct inhaler technique is poor, which impedes patients from receiving maximum clinical benefit from their medication. In this study, the Inhaler Compliance Assessment device was employed to record audio of patients using a Diskus dry powder inhaler. An algorithm that classifies inhaler sounds (blister, inhalation, interference) was developed to automatically assess patient adherence from these inhaler audio recordings. The presented algorithm employed audio-based signal processing methods and statistical modeling in the form of quadratic discriminant analysis (QDA). A total of 350 audio recordings were obtained from 70 patients. The acquired audio dataset was split evenly for training and testing. A total accuracy of 85.35% was obtained (testing dataset) for this 3-class classification system. A sensitivity of 89.22% and 70% was obtained for inhalation and blister detection respectively. This approach may have significant clinical impact by providing healthcare professionals with an efficient, objective method of monitoring patient adherence to inhaler treatment.

Technical challenges in obtaining an optimized powder/DPI combination for inhalation delivery of a bi-component generic drug

Development of bi-component generic orally inhaled product (OIP) delivered from dry powder inhaler (DPI) is challenging due to the necessity to demonstrate the similarity of size distribution of both APIs in inhaled aerosol. The effects of selected technical factors on OIP development are investigated. The Monodose inhalers with different aerodynamic resistance were used to aerosolize generic fluticasone/salmeterol formulations. Flow dynamics in the DPIs was analyzed during realistic use. The effects of lactose grade, capsule types and blending equipment on aerosol particle size were studied with compendial methods. The best dispersion of bi-component powder was obtained in a medium-resistant (∼0.108 hPa0.5 min L−1) Monodose DPI as compared to low- and high-resistant devices. All studied technological factors had influence on the fine particle dose of each API and fluticasone/salmeterol mass ratio. It was demonstrated that the selected Monodose inhaler in combination with the newly developed bi-component drug formulation was able to reproduce the quality of inhalable aerosol obtained from Diskus DPI. Since powder dispersion depends on the energy available in a single breath, an optimized DPI is needed in generic OIP. By adjusting several technological factors it is possible to obtain the reproducible product with the required dose of each aerosolized APIs.

Characteristics of patients making serious inhaler errors with a dry powder inhaler and association with asthma-related events in a primary care setting

Objective: Correct inhaler technique is central to effective delivery of asthma therapy. The study aim was to identify factors associated with serious inhaler technique errors and their prevalence among primary care patients with asthma using the Diskus dry powder inhaler (DPI). Methods: This was a historical, multinational, cross-sectional study (2011–2013) using the iHARP database, an international initiative that includes patient- and healthcare provider-reported questionnaires from eight countries. Patients with asthma were observed for serious inhaler errors by trained healthcare providers as predefined by the iHARP steering committee. Multivariable logistic regression, stepwise reduced, was used to identify clinical characteristics and asthma-related outcomes associated with ≥1 serious errors. Results: Of 3681 patients with asthma, 623 (17%) were using a Diskus (mean [SD] age, 51 [14]; 61% women). A total of 341 (55%) patients made ≥1 serious errors. The most common errors were the failure to exhale before inhalation, insufficient breath-hold at the end of inhalation, and inhalation that was not forceful from the start. Factors significantly associated with ≥1 serious errors included asthma-related hospitalization the previous year (odds ratio [OR] 2.07; 95% confidence interval [CI], 1.26–3.40); obesity (OR 1.75; 1.17–2.63); poor asthma control the previous 4 weeks (OR 1.57; 1.04–2.36); female sex (OR 1.51; 1.08–2.10); and no inhaler technique review during the previous year (OR 1.45; 1.04–2.02). Conclusions: Patients with evidence of poor asthma control should be targeted for a review of their inhaler technique even when using a device thought to have a low error rate.

A Preference Study of Two Placebo Dry Powder Inhalers in Adults with COPD: ELLIPTA® Dry Powder Inhaler (DPI) versus DISKUS® DPI

Patients' preference is an important factor in selecting an inhaler treatment for COPD. The DISKUS® dry powder inhaler (DPI), which has been available to deliver several COPD medications for a decade, and the ELLIPTA® DPI, developed for the delivery of newer once-daily medications for patients with COPD, were studied in terms of patient preference and inhaler-specific attributes.We conducted a randomized, open-label, crossover study in patients with COPD. Patients used placebo ELLIPTA DPI once daily and placebo DISKUS DPI twice daily, for ∼1 week each, while continuing their COPD medications. Endpoints were: inhaler preference based on size of the numbers on the dose-counter (primary); the number of steps needed and inhaler size (secondary); and based on comfort of the mouthpiece, ease of opening, overall preference, and dosing regimen preference (‘other’). Safety assessments included adverse events (AEs).A total of 287 patients were randomized. A significantly (p < 0.001) larger proportion of patients preferred the ELLIPTA DPI over DISKUS DPI for each of the tested attributes and overall, and preferred once-daily over twice-daily dosing. AEs were reported for 36 patients (13%); one (dry mouth) was considered to be related to the placebo-containing DISKUS DPI. Three patients had five non-fatal serious AEs, none were deemed inhaler-related.This study demonstrated that more patients with COPD preferred five specific inhaler attributes of the ELLIPTA DPI over DISKUS DPI and overall, and preferred once-daily versus twice-daily dosing. Safety profiles were consistent with those expected for COPD.

Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma

Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma

Acoustic Analysis of Inhaler Sounds From Community-Dwelling Asthmatic Patients for Automatic Assessment of Adherence.

Inhalers are devices which deliver medication to the airways in the treatment of chronic respiratory diseases. When used correctly inhalers relieve and improve patients' symptoms. However, adherence to inhaler medication has been demonstrated to be poor, leading to reduced clinical outcomes, wasted medication, and higher healthcare costs. There is a clinical need for a system that can accurately monitor inhaler adherence as currently no method exists to evaluate how patients use their inhalers between clinic visits. This paper presents a method of automatically evaluating inhaler adherence through acoustic analysis of inhaler sounds. An acoustic monitoring device was employed to record the sounds patients produce while using a Diskus dry powder inhaler, in addition to the time and date patients use the inhaler. An algorithm was designed and developed to automatically detect inhaler events from the audio signals and provide feedback regarding patient adherence. The algorithm was evaluated on 407 audio files obtained from 12 community dwelling asthmatic patients. Results of the automatic classification were compared against two expert human raters. For patient data for whom the human raters Cohen's kappa agreement score was n}{}{>}{0.81}, results indicated that the algorithm's accuracy was 83% in determining the correct inhaler technique score compared with the raters. This paper has several clinical implications as it demonstrates the feasibility of using acoustics to objectively monitor patient inhaler adherence and provide real-time personalized medical care for a chronic respiratory illness.

P225 Inhaler use and misuse on the wards of Hospital

Clinicians are aware that inhalers are often improperly used incorrectly by patients. However, it often difficult to assess, because at present there is no tool that directly quantify adherence. We...

Adherence logger for a dry powder inhaler: A new device for medical adherence research

Adherence to inhaled steroid regimens is frequently poor. Finding ways to improve adherence depends on the ability to measure time and date of inhaler use reliably and to detect deliberate dose dumping. There is no such monitor for the popular new dry powder inhalers. To develop and test an electronic monitor for a dry powder inhaler that will provide information on the time and date of use. An electronic adherence monitor for the Advair Diskus dry powder inhaler was developed and tested. In this device, inhaler use is determined by detecting and recording the motion of the drug delivery lever in the inhaler with a magnetic sensor. An additional electronic interface and software were also developed to allow the adherence data to be uploaded to a computer for display and analysis. System and reliability tests involving multiple-day and repeated-use tests of the adherence monitor demonstrate the overall performance and reliability of the device, and specifically its ability to record the time and date of dose delivery. In the repeated-use test, 300 successive actuations of the dose delivery lever were correctly sensed and recorded without error. The simple-to-use, low-cost, reusable adherence monitor accurately records time and date of inhaler use and thus allows clinical monitoring and adherence studies in patients using the Advair Diskus dry powder inhaler. The same technology should be adaptable to other dry powder inhalers, including the Pulmicort Tubuhaler and the Symbicort Tubuhaler.

Clinical and functional responses to salbutamol inhaled via different devices in asthmatic patients with induced bronchoconstriction

This study aimed at evaluating changes in airway patency, lung volumes and perception of breathing discomfort intensity following salbutamol administration via the Diskus dry-powder inhaler (DPI) or a pressurized metered-dose inhaler with the Volumatic valved holding chamber (pMDI + Volumatic) in asthmatic patients with methacholine-induced bronchoconstriction. On six different study days, 18 patients inhaled methacholine until forced expiratory volume in 1 s (FEV(1)) decreased by approximately 35% of baseline. Following placebo, 200 and 400 microg of salbutamol through the pMDI + Volumatic or the Diskus, changes in FEV(1), volume-adjusted mean forced expiratory flow from 25 to 75% of the forced vital capacity (isoFEF(25-75)), lung volumes and breathing discomfort intensity, assessed by visual analogue scale (VAS) score, were repeatedly measured over a 60-min observation period. Induced bronchoconstriction was accompanied by obvious reductions in lung volumes and increases in VAS score. After salbutamol administration, FEV(1) and VAS score changes were similar in all experimental conditions. However, following 400 microg salbutamol via pMDI + Volumatic, isoFEF(25-75) values increased up to 4.48 l s(-1) (95% confidence interval 4.06, 4.90), a significantly (P < 0.01) higher value than those attained in all other experimental conditions. Independently of the salbutamol dose, lung volumes rose to significantly (P < 0.01) higher levels in pMDI + Volumatic than in Diskus trials. The low salbutamol dose via the pMDI + Volumatic and the high dose via the DPI increased isoFEF(25-75) and lung volumes to similar extents. Salbutamol via the pMDI + Volumatic provides greater isoFEF(25-75) and lung volume increases in asthmatic patients with induced bronchoconstriction; salbutamol-induced changes in VAS scores poorly reflect those in small airway patency. The lack of differences in FEV(1) increases observed after 200 and 400 microg salbutamol may reflect attainment of the flat portion of the dose-response curve using either device.

Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: A randomized, double-blind, placebo-controlled trial

Background: Many patients with persistent asthma need both long-acting bronchodilators and inhaled corticosteroids for optimal asthma control. Objective: Our purpose was to compare the efficacy and safety of salmeterol 50 μg combined with fluticasone 100 μg (in a combination dry powder product) with that of placebo, fluticasone, or salmeterol alone. Methods: A 12-week randomized, double-blind, multicenter study was conducted in 356 patients aged 12 years or older with asthma. After a 14-day screening period, patients were randomized to treatment with salmeterol 50 μg combined with fluticasone 100 μg (combination product), salmeterol 50 μg, fluticasone 100 μg, or placebo administered in the Diskus dry powder inhaler (GlaxoWellcome, UK) twice daily. Results: Mean change in FEV 1 at end point was significantly ( P ≤ .003) greater with the combination product (0.51 L) compared with placebo (0.01 L), salmeterol (0.11 L), and flutica-sone (0.28 L). The combination product significantly increased ( P ≤ .013) area under the curve compared with placebo and fluticasone on day 1 and compared with placebo, salmeterol, and fluticasone at week 1 and week 12. Patients in the combination product group were less likely to withdraw from the study because of worsening asthma compared with those in the other groups ( P ≤ .020). The combination product significantly increased ( P ≤ .012) morning PEF (combination, 52.5 L/min; placebo, –23.7 L/min; salmeterol, –1.7 L/min; fluticasone, 17.3 L/min) and evening PEF at end point compared with the other groups. The combination product significantly ( P ≤ .025) reduced symptom scores and albuterol use compared with the other treatments and increased the percentage of nights with no awakenings and the percentage of days with no symptoms compared with placebo and salmeterol. All treatments were equally well tolerated. Conclusion: Salmeterol 50 μg and fluticasone 100 μg combined in the Diskus powder delivery device offers significant clinical advantages over salmeterol or fluticasone alone at the same doses. (J Allergy Clin Immunol 2000;105:1108-16.)