Identifying patients at risk of poor asthma outcomes associated with making inhaler technique errors.

OBJECTIVES: Correct inhaler technique is essential to optimal clinical outcomes in asthma patients. The study aim was to use real-life data from the iHARP database to determine patient factors associated with the performance of inhaler technique errors associated with poor asthma outcomes (as identified in the Critikal study) in patients with asthma prescribed the Turbuhaler (TH), Metered Dose Inhaler (MDI), and Accuhaler (AH) device. METHODS: This was a retrospective cross-sectional study using the iHARP database, a multinational initiative including questionnaires and technique review. Identification of inhaler technique errors specifically associated with poor asthma outcomes was performed by reference to the Critikal study. Multivariable logistic regression was used to identify demographic and clinical factors associated with ≥ 1 of these errors. RESULTS: Factors significantly associated with ≥ 1 inhaler technique error and worsening asthma outcomes for the TH cohort include female gender, very poor to average self-assessment of inhaler technique; for the MDI cohort, female gender, secondary education, and current smoking status; and, in the AH cohort, lack of inhaler technique review by a trained healthcare professional in the previous twelve months and very poor to average self-assessment of inhaler technique. CONCLUSIONS: Numerous specific patient demographic and clinical factors associated with the performance of these errors have been identified, differing according to device. Inhaler technique error associated with poor asthma outcomes is further widespread across devices. Knowledge of these factors and the frequency of their occurence may assist in optimizing device selection and training.

Climate change in healthcare: Exploring the potential role of inhaler prescribing.

Climate change has been described as the biggest global health threat of the 21st century. As a result, governments around the world are committing to legislative change in order to reduce greenhouse gas emissions (GHGEs). The healthcare sector makes a significant contribution to GHGEs and in line with national legislation in the UK, the NHS has recently committed to achieving net zero emissions by 2050. The management of asthma and COPD largely depends on the prescribing of medications that are delivered through inhalers. In the UK, the use of pressurized metered dose inhalers (pMDIs), which rely on hydrofluorocarbon (HFC) propellants accounts for 3.5% of the NHS's total carbon footprint. In contrast, dry powder inhalers (DPIs) have a much lower carbon footprint due to the absence of a HFC propellant. Here we review evidence of the impact of inhaler choices across four domains: environmental impact, clinical effectiveness, cost effectiveness and patient preferences. We find that as well as a lower global-warming potential, DPIs have additional benefits over pMDIs in other domains and should be considered first line where clinically appropriate.

Pathways for Improving Inpatient Pediatric Asthma Care (PIPA): A Multicenter, National Study.

BACKGROUND AND OBJECTIVES: Pathways guide clinicians through evidence-based care of specific conditions. Pathways have been demonstrated to improve inpatient asthma care but mainly in studies at large, tertiary children's hospitals. It remains unclear if these effects are generalizable across diverse hospital settings. Our objective was to improve inpatient asthma care by implementing pathways in a diverse, national sample of hospitals. METHODS: We used a learning collaborative model. Pathway implementation strategies included local champions, external facilitators and/or mentors, educational seminars, quality improvement methods, and audit and feedback. Outcomes included length of stay (LOS) (primary), early administration of metered-dose inhalers, screening for secondhand tobacco exposure and referral to cessation resources, and 7-day hospital readmissions or emergency revisits (balancing). Hospitals reviewed a sample of up to 20 charts per month of children ages 2 to 17 years who were admitted with a primary diagnosis of asthma (12 months before and 15 months after implementation). Analyses were done by using multilevel regression models with an interrupted time series approach, adjusting for patient characteristics. RESULTS: Eighty-five hospitals enrolled (40 children's and 45 community); 68 (80%) completed the study (n = 12 013 admissions). Pathways were associated with increases in early administration of metered-dose inhalers (odds ratio: 1.18; 95% confidence interval [CI]: 1.14-1.22) and referral to smoking cessation resources (odds ratio: 1.93; 95% CI: 1.27-2.91) but no statistically significant changes in other outcomes, including LOS (rate ratio: 1.00; 95% CI: 0.96-1.06). Most hospitals (65%) improved in at least 1 outcome. CONCLUSIONS: Pathways did not significantly impact LOS but did improve quality of asthma care for children in a diverse, national group of hospitals.

Use of secret simulated patient followed by workshop based education to assess and improve inhaler counseling in community pharmacy in Jordan

OBJECTIVES: To assess inhaler technique demonstration skills of community pharmacists located in Amman, Jordan via incorporating the trained secret simulated patient (SSP) approach. Secondly, to evaluate the effectiveness of a 2-hour educational workshop focused on SSP feedback. METHODS: This cross-sectional study involved community pharmacies located in Amman, Jordan. Initially, a trained SSP was involved to enact baseline visits requesting advice on how to use Ventolin(R) (a pressurized metered-dose inhaler; pMDI) and Pulmicort(R) (a Turbohaler inhaler, TH). Immediately after each visit, the SSP completed an inhaler technique evaluation form with inhaler checklists based on previously published checklists (consisting of 9 and 10 items for pMDI and TH respectively). The SSP invited all participating pharmacists to a 2-hour workshop that included feedback on their demonstration skills, and the second evaluation of their inhaler technique. The workshop included a summary of the initial visits' results highlighting pharmacists' performance. RESULTS: Sixty pharmacies were visited and 120 inhaler assessments were completed. During baseline assessment, pharmacists scored an average of 4.5 out of 9 for pMDI and 4.9 out of 10 for TH. Only 11 pharmacists (18.3%) attended the workshop. During the workshop, inhaler technique demonstration skills significantly improved, as scores improved from 5.4 (SD 1.6) to 7.8 (SD 0.9) (p = 0.008) and from 4.6 (SD 2.5) to 9.9 (SD 0.6) (p = 0.003) for pMDI and TH respectively. CONCLUSIONS: The SSP approach revealed a lack of ability to demonstrate correct inhaler technique for pMDI and TH inhalers by community pharmacists in Amman, Jordan. A focused educational workshop based on SSP feedback improved inhaler technique significantly

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BET 1: Efficacy of different techniques using a metered-dose inhaler with Spacer to relieve symptoms in children with acute asthma.

A shortcut review was carried out to establish which inhaler with spacer technique provides the greatest improvement in symptoms in children with acute asthma. Four relevant papers were identified for inclusion using the reported search strategy. The author, date and country of publication; group studied; study type; relevant outcomes; results and study weaknesses of these papers are tabulated. It is concluded that a 'tidal breathing' technique, with a minimum of three breaths per inhaler activation, is likely equivalent in efficacy to a 'single breath and hold technique', and easier for a breathless child to perform.

Difficult-to-treat and severe asthma in adults: Towards a new treatment paradigm.

BACKGROUND: Asthma is a common yet complex airway disorder, comprising diverse phenotypes and pathophysiology. According to the Australian Institute of Health and Welfare, asthma affects 11% of the Australian population. Despite the availability of effective therapies and a national medicines subsidy scheme, a significant burden of disease still exists in Australia, with high mortality by international standards. OBJECTIVE: This article discusses the challenges in managing patients with difficult-to-treat and severe asthma in primary care, how to distinguish between difficult-to-treat and severe asthma, when to refer, and the role of biologic therapy. DISCUSSION: Asthma that remains uncontrolled despite treatment with high-dose preventive therapies is not only challenging for clinicians but also imposes long-term, debilitating burdens on patients' quality of life. Recent advances in evidence-based guidelines for severe asthma, increasing evidence about phenotypic patterns and asthma biomarkers, and the availability of targeted biologic therapies offer hope for improving patient outcomes.

Imperative Instruction for Pressurized Metered-Dose Inhalers: Provider Perspectives.

BACKGROUND: Reports show that many patients do not use their pressurized metered-dose inhalers (pMDIs) effectively. The National Heart, Lung, and Blood Institute recommends that health-care providers educate and assess patients' pMDI technique at each opportunity. However, limited data exist regarding how often pediatric primary care providers perform assessments and which methods they use. We sought to (1) identify instructional methods used to teach pMDI use, (2) describe how pMDI use is reassessed at follow-up visits, and (3) describe primary care provider attitudes and barriers to in-office pMDI instruction. METHODS: A 34-item electronic survey was distributed from August to December 2016 via E-mail to local pediatric primary care providers. Descriptive statistics were used for analysis. RESULTS: Sixty two of 223 potential primary care providers (28%) responded. Physicians and nurse practitioners were identified most often as the providers of pMDI education (53%). When first prescribing a pMDI, only 10% reported having the patient practice inhaler use in the office and receive feedback. Only 19% "always" reassessed the technique, even for patients with poorly controlled asthma. Among those who reassessed the technique, most (76%) did so verbally, and only 42% asked the patients to demonstrate pMDI use. Only 32% reported that typical patient education in their setting was adequate to ensure proper pMDI use. Commonly cited barriers included time (84%) and access to demo pMDIs (67%). Provider solutions included video tutorials and access to demo inhalers. CONCLUSIONS: Many pediatric primary care providers did not demonstrate or have patients practice pMDI use when teaching or assessing pMDI technique, and the reassessment rate was low even for patients with poorly controlled asthma. Identifying and training a consistent pMDI educator and obtaining demo pMDIs may abate some barriers. Respiratory therapists could appropriately fulfill this educator role. Brief, repeated pMDI practice for motor learning could promote more stable pMDI mastery.

Clinical burden of asynchrony in patients with asthma when using metered-dose inhalers for control.

Background: Asynchrony, or lack of coordination between inhalation and actuation when using a pressurized metered-dose inhaler (MDI), could theoretically impact the delivery of inhaled medications and treatment efficacy. Objective: To assess the real-world association between asynchrony and clinical outcomes among patients with asthma who receive controller therapy delivered by MDIs. Methods: A cohort of patients was assembled via electronic health records. The patients were aged ≥12 years, with one or more documentations of an asthma diagnosis, no diagnosis of chronic obstructive pulmonary disease, and two or more prescriptions for an inhalation aerosol corticosteroid alone or with long-acting beta-2-agonist delivered via MDI. Their inhaler technique, demonstrated by using a placebo MDI, was evaluated at a clinic visit by study nurses who used a standardized 10-step checklist. Asynchrony was defined as any gap in timing between inhalation and actuation. Clinical outcomes were assessed via electronic health records during the 6 months before the clinic visit and were compared between patients with and patients without asynchrony by using multivariable regression analyses adjusted for age, gender, asthma severity proxy, and baseline comorbidities. Results: Of the total 254 eligible patients, mean age of 49.3 years, 90 males (35.4%), 32 (12.6%) had asynchrony. Patients with asynchrony had higher odds of an asthma exacerbation (adjusted odds ratio, 2.99; p = 0.009), and lower odds of risk domain asthma control (adjusted odds ratio, 0.41; p = 0.04) compared with patients without asynchrony. Conclusion: This study provided real-world evidence that asynchrony in MDI use among patients with asthma who were treated with controller MDIs was associated with clinical burden in terms of asthma exacerbations and control.

A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers.

BACKGROUND: Despite little evidence for its effectiveness, the breath-actuated nebulizer (BAN) is the default albuterol delivery method in our pediatric emergency department. OBJECTIVE: We compared the clinical efficacy of BAN and the metered-dose inhaler (MDI) in treating subjects patients 2 to 17 years of age who presented with mild to moderate asthma exacerbations. METHODS: This is a randomized, nonblinded, noninferiority study conducted at a single pediatric tertiary care emergency department. Subjects presenting with a Pediatric Asthma Score ranging from 5 to 11 received albuterol by BAN or MDI via standard weight-based and symptom severity dosing protocols. Aerosolized ipratropium (via BAN) and intravenous magnesium sulfate were given when clinically indicated. The primary outcome was patient disposition. The noninferiority margin for the primary outcome was an admission rate difference ≤10%. Analyses were adjusted for confounders that were significant at p ≤ 0.10. RESULTS: We enrolled 890 subjects between October 2014 and April 2015. BAN and MDI groups were comparable for age, gender, and race but not for pretreatment symptom severity; 51% in the MDI group had a Pediatric Asthma Score of moderate severity (8-11) vs. 63% in the BAN group (p < 0.003). Unadjusted admission rates were 11.9% for MDI and 12.8% for BAN, for an unadjusted risk difference of -0.9% (95% confidence interval -5% to 3%). After adjusting for baseline confounder severity, the risk difference was 2% (95% confidence interval -4% to 7%), which met the criteria for noninferiority. CONCLUSIONS: Albuterol therapy by MDI is noninferior to BAN for the treatment of mild to moderate asthma exacerbations in children 2 to 17 years of age.

Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes.

BACKGROUND: Inhaled drug delivery is the cornerstone treatment for asthma and chronic obstructive pulmonary disease (COPD). However, use of inhaler devices can be challenging, potentially leading to critical errors in handling that can significantly reduce drug delivery to the lungs and effectiveness of treatment. METHODS: A systematic review was conducted to define 'critical' errors and their impact on health outcomes and resource use between 2004 and 2016, using key search terms for inhaler errors in asthma and COPD (Search-1) and associated health-economic and patient burden (Search-2). RESULTS: Search-1 identified 62 manuscripts, 47 abstracts, and 5 conference proceedings (n = 114 total). Search-2 identified 9 studies. We observed 299 descriptions of critical error. Age, education status, previous inhaler instruction, comorbidities and socioeconomic status were associated with worse handling error frequency. A significant association was found between inhaler errors and poor disease outcomes (exacerbations), and greater health-economic burden. CONCLUSIONS: We have shown wide variations in how critical errors are defined, and the evidence shows an important association between inhaler errors and worsened health outcomes. Given the negative impact diminished disease outcomes impose on resource use, our findings highlight the importance of achieving optimal inhaler technique, and a need for a consensus on defining critical and non-critical errors.

Drug Delivery from an Innovative LAMA/LABA Co-suspension Delivery Technology Fixed-Dose Combination MDI: Evidence of Consistency, Robustness, and Reliability.

To ensure consistency of clinical outcomes, orally inhaled therapies must exhibit consistent delivered dose and aerosol properties at the time of manufacturing, throughout storage, and during various patient-use conditions. Achieving consistency across these scenarios has presented a significant challenge, especially for combination products that contain more than one drug. This study characterized the delivered dose and aerosol properties of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI; Bevespi Aerosphere™). GFF MDI, a fixed-dose combination (FDC) of a long-acting muscarinic antagonist, glycopyrrolate (18 µg, equivalent to glycopyrronium 14.4 µg), and a long-acting ß2-agonist, formoterol fumarate (9.6 µg; equivalent to formoterol fumarate dihydrate 10 µg), is formulated using innovative co-suspension delivery technology, which suspends micronized drug crystals with spray-dried phospholipid porous particles in hydrofluoroalkane propellant. In this study, delivered dose uniformity was assessed through the labeled number of doses, and aerosol properties, such as percent fine particle fraction (FPF) and mass median aerodynamic diameter, were determined by cascade impaction. GFF MDI achieved reproducible dose delivery and an FPF greater than 55%, whether formulated and delivered as a monocomponent or dual FDC. The performance of GFF MDI was maintained across various manufacturing batches, under extended storage, and with variations in flow rate. Furthermore, unlike a GFF drug crystal-only suspension, drug delivery remained consistent for GFF MDI when simulated patient-handling errors were applied, such as reduced shake energy and delays between shaking and actuation. These results demonstrate that co-suspension delivery technology overcomes well-known sources of variability in MDI drug delivery.

Evaluation of beclomethasone dipropionate (80 and 160 micrograms/day) delivered via a breath-actuated inhaler for persistent asthma.

BACKGROUND: Breath-actuated inhalers (BAI) may simplify the delivery of inhaled medications compared with other devices. OBJECTIVE: To evaluate the efficacy and safety of beclomethasone dipropionate BAI versus matching placebo in adolescent and adult patients with persistent asthma. METHODS: This phase III, 12-week, double-blind study enrolled patients with asthma aged ≥12 years who were previously treated with a stable dose of inhaled corticosteroid or noncorticosteroid therapy. After a run-in period of 14 to 21 days, patients were randomly assigned in a 1:1:1 ratio to beclomethasone dipropionate BAI 80 or 160 micrograms/day (40 or 80 micrograms twice daily) or placebo BAI. The primary end point was the standardized baseline-adjusted trough morning forced expiratory volume in 1 second (FEV1) area under the effect curve from time 0 to 12 weeks (AUEC[0-12 weeks]). Secondary end points included peak expiratory flow, rescue medication use, asthma symptoms, and the time to withdrawal due to meeting predefined criteria for worsening asthma. Additional end points evaluated quality of life, instructions for use, and safety. RESULTS: The full analysis and the safety sets included 270 and 273 patients, respectively. Patients who received beclomethasone dipropionate BAI 80 or 160 micrograms/day had significant improvements in FEV1 AUEC(0-12 weeks) versus placebo (p ≤ 0.001). Improvements in secondary end points were also apparent in patients who received beclomethasone dipropionate BAI 80 or 160 micrograms/day compared with placebo. Patients who received beclomethasone dipropionate BAI 80 or 160 micrograms/day had greater increases in Asthma Quality of Life Questionnaire scores versus placebo patients at week 12. Of 98 patients who participated in the instructions-for-use substudy, 87 (88.8%) used the inhaler successfully on their first attempt. Treatment was generally safe and well tolerated. CONCLUSION: Beclomethasone dipropionate BAI 80 and 160 micrograms/day were effective and well-accepted treatments in patients with asthma, with safety comparable to beclomethasone dipropionate delivered via a metered-dose inhaler.Clinical trial NCT02040779, www.clinicaltrials.gov.

Aerosol: A Novel Vehicle for Pharmacotherapy in Neonates.

BACKGROUND: Local delivery of drugs to the lungs of newborn infant represents an unmet need as no drugs have been approved. Potential benefits could be large. Development of aerosol for delivery of drugs to infants and newborn offers huge potential for better therapy. Newborn infants present unique challenges with regard to aerosol therapy. Efficient deposition of aerosolized medications on the neonate airway surface is hampered by anatomical features such as small airway geometries and physiological features such as exquisitely small tidal volumes, rapid breathing and unfavorable inhalation:exhalation ratios. METHODS: The selection of aerosol generators capable of delivering any more than a few percent of the nominal drug dose to the airways remains extremely limited with nebulizers and pressurized metered dose inhalers being predominantly used. Further hampering the development of bespoke high performance aerosol therapy for neonates is the as yet unknown ideal droplet size. RESULTS: Droplet size is a critical determinant of the amount of aerosol that escapes the patient circuit, becoming available to the patient, and subsequently the location of deposition within the lung. It is assumed that smaller is better at traversing the tortuous path from aerosol generator to airway surface. To date, patient interface has been shown to have little effect with respect to delivered dose, but some may provide advantage with respect to ease of use and patient acceptance. CONCLUSION: The present review iteratively describes the difficulties in achieving optimized aerosol drug delivery in neonates. We suggest possible technical solutions aimed at improving delivery and developing a platform for increased reliability and reproducibility of dosing such that new and existing medications may exploit the potential advantages of aerosol therapy in the neonate population.

Discriminating Ability of Abbreviated Impactor Measurement Approach (AIM) to Detect Changes in Mass Median Aerodynamic Diameter (MMAD) of an Albuterol/Salbutamol pMDI Aerosol.

This article reports on results from a two-lab, multiple impactor experiment evaluating the abbreviated impactor measurement (AIM) concept, conducted by the Cascade Impaction Working Group of the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). The goal of this experiment was to expand understanding of the performance of an AIM-type apparatus based on the Andersen eight-stage non-viable cascade impactor (ACI) for the assessment of inhalation aerosols and sprays, compared with the full-resolution version of that impactor described in the pharmacopeial compendia. The experiment was conducted at two centers with a representative commercially available pressurized metered dose inhaler (pMDI) containing albuterol (salbutamol) as active pharmaceutical ingredient (API). Metrics of interest were total mass (TM) emitted from the inhaler, impactor-sized mass (ISM), as well as the ratio of large particle mass (LPM) to small particle mass (SPM). ISM and the LPM/SPM ratio together comprise the efficient data analysis (EDA) metrics. The results of the comparison demonstrated that in this study, the AIM approach had adequate discrimination to detect changes in the mass median aerodynamic diameter (MMAD) of the ACI-sampled aerodynamic particle size distribution (APSD), and therefore could be employed for routine product quality control (QC). As with any test method considered for inclusion in a regulatory filing, the transition from an ACI (used in development) to an appropriate AIM/EDA methodology (used in QC) should be evaluated and supported by data on a product-by-product basis.

Development and Evaluation of a Family of Human Face and Upper Airway Models for the Laboratory Testing of Orally Inhaled Products.

Many orally inhaled products are supplied with a facemask instead of a mouthpiece, enabling aerosolized medication to be transferred from the inhaler to the lungs when the user lacks the capability to use a mouthpiece. Until recently, laboratory evaluation of an orally inhaled product-facemask was frequently undertaken by removing the facemask, treating the facemask adapter as being equivalent to a mouthpiece. Measurements of delivered drug mass were therefore subject to bias arising from the absence of dead volume, had the facemask been present. We have described the development of the Aerosol Delivery to an Anatomic Model (ADAM) infant, small child, and adult faces and upper airways, and their subsequent evaluation. Each model possesses physical features of appropriate size, and the soft tissues are also simulated. Rudimentary underlying bony structure is also present, because its purpose is only to provide support, enabling the mechanical response of the facial soft tissues when a facemask is applied to be realized. A realistic upper airway (nasopharynx for the infant model, naso- and oropharynx for the child and oropharynx for the adult models) is also incorporated, so that each model can be used to determine the mass of inhaled medication likely to penetrate as far as the lungs where therapy is intended to be applied. Measurements of the mass of pressurized metered-dose inhaler-delivered salbutamol at a filter distal to the upper airway of each model, simulating age-appropriate tidal breathing, were remarkably consistent, almost all being in the range 0.3 to 1.0 µg/kg across the model age ranges, when expressed as a fraction of body weight.

[Bench-test evaluation of spacer devices for fluticasone delivery to infants]. / Chambres d'inhalation pour délivrance de fluticasone chez le nourrisson au banc d'essai.

INTRODUCTION: Use of a spacer device to optimize the delivery of fluticasone to infants with asthma is an important issue and clinicians require guidance around the choice of device. This in vitro study characterizes the particle size and the fluticasone delivery via 9 spacers. METHODS: We used an in vitro infant nasal cast with two different inspiratory flow rates (50 and 100mL/s). Fluticasone particle size in the aerosol was evaluated by laser diffractometry and tracheal deposition by spectrophotometric assay. RESULTS: Significant differences in particle size were observed between the 9 spacers (similar D50 but D90 from 5.65±0.65 to 8.80±1.35µm). A 75 % or higher respirable fraction was obtained for only 5 spacers. The 50mL/s flow rate lead to the best drug delivery. At this flow, OptiChamber® (62±3 %) and Vortex® (91±8.5 %) had a tracheal deposition over 50 % of the initial dose of fluticasone, although the 7 other spacers exhibited a fluticasone deposition less than 25 %. DISCUSSION: This study shows a wide variation of drug delivery between the 9 spacers studied. We demonstrate that a low inspiratory flow and a spacer showing antistatic properties facilitate drug delivery.

Effectiveness of Various Methods of Teaching Proper Inhaler Technique.

OBJECTIVE: To compare the effectiveness of 4 different instructional interventions in training proper inhaler technique. DESIGN: Randomized, noncrossover trial. SETTING: Health fair and indigent clinic. PARTICIPANTS: Inhaler-naive adult volunteers who spoke and read English. INTERVENTIONS: Subjects were assigned to complete the following: (1) read a metered dose inhaler (MDI) package insert pamphlet, (2) watch a Centers for Disease Control and Prevention (CDC) video demonstrating MDI technique, (3) watch a YouTube video demonstrating MDI technique, or (4) receive direct instruction of MDI technique from a pharmacist. PRIMARY OUTCOME: Inhaler use competency (completion of all 7 prespecified critical steps). RESULTS: Of the 72 subjects, 21 (29.2%) demonstrated competent inhaler technique. A statistically significant difference between pharmacist direct instruction and the remaining interventions, both combined ( P < .0001) and individually ( P ≤ .03), was evident. No statistically significant difference was detected among the remaining 3 intervention groups. Critical steps most frequently omitted or improperly performed were exhaling before inhalation and holding of breath after inhalation. CONCLUSION: A 2-minute pharmacist counseling session is more effective than other interventions in successfully educating patients on proper inhaler technique. Pharmacists can play a pivotal role in reducing the implications of improper inhaler use.

Incidence of oral thrush in patients with COPD prescribed inhaled corticosteroids: Effect of drug, dose, and device.

BACKGROUND AND AIMS: Little information is available on real-life occurrence of oral thrush in COPD patients treated with ICS. We investigated oral thrush incidence in COPD patients prescribed FDC ICS/LABA therapies and assessed whether it is modulated by the ICS type, dose, and delivery device. METHODS: We conducted a historical, observational, matched cohort study (one baseline year before and one outcome year after initiation of therapy) using data from the UK Optimum Patient Care Research Database. We assessed oral thrush incidence in patients initiating long-acting bronchodilators or FDC ICS/LABA therapy. We then compared different combination therapies (budesonide/formoterol fumarate dihydrate [BUD/FOR] and fluticasone propionate/salmeterol xinafoate [FP/SAL]) and devices (DPI and pMDI). RESULTS: Patients prescribed FDC ICS/LABA had significantly greater odds of experiencing oral thrush than those prescribed long-acting bronchodilators alone (adjusted OR 2.18 [95% CI 1.84-2.59]). Significantly fewer patients prescribed BUD/FOR DPI developed oral thrush compared with FP/SAL DPI (OR 0.77 [0.63-0.94]) when allowing for differences in prescribed doses between the drugs. A significantly smaller proportion of patients developed oral thrush in the FP/SAL pMDI arm than in the FP/SAL DPI arm (OR 0.67 [0.55-0.82]). Additionally, in the FP/SAL cohort (both DPI and pMDI), increased risk of oral thrush was significantly associated with high ICS daily dose (OR 1.97 [1.22-3.17] vs low daily dose). CONCLUSIONS: ICS use increases oral thrush incidence in COPD and this effect is dose-dependent for FP/SAL therapies. Of the therapies assessed, FP/SAL pMDI and BUD/FOR DPI may be more protective against oral thrush.

Pressurised metered dose inhaler-spacer technique in young children improves with video instruction.

UNLABELLED: The importance of good device technique to maximise delivery of aerosolised medications is widely recognised. Pressurised metered dose inhaler (pMDI)-spacer technique was investigated in 122 children, aged 2-7 years, with asthma. Eight individual steps of device technique were evaluated before and after viewing an instructional video for correct device technique. Video measurements were repeated every three months for nine months. Device technique improved directly after video instruction at the baseline study visit (p < 0.001) but had no immediate effect at subsequent visits. Additionally, pMDI-spacer technique improved with successive visits over one year for the group overall as evidenced by increases in the proportion of children scoring maximal (p = 0.02) and near-maximal (p = 0.04) scores. CONCLUSION: Repeated video instruction over time improves inhaler technique in young children. WHAT IS KNOWN: • Correct device technique is considered essential for sufficient delivery of inhaled medication. • Poor inhaler use is common in young asthmatic children using pressurised metered dose inhalers and spacers. What is New: • Video instruction could be used as a strategy to improve device technique in young children.