Greenhouse gas emissions associated with suboptimal asthma care in the UK: the SABINA healthCARe-Based envirONmental cost of treatment (CARBON) study.

BACKGROUND: Poorly controlled asthma is associated with increased morbidity and healthcare resource utilisation (HCRU). Therefore, to quantify the environmental impact of asthma care, this retrospective, cohort, healthCARe-Based envirONmental cost of treatment (CARBON) study estimated greenhouse gas (GHG) emissions in the UK associated with the management of well-controlled versus poorly controlled asthma. METHODS: Patients with current asthma (aged ≥12 years) registered with the Clinical Practice Research Datalink (2008‒2019) were included. GHG emissions, measured as carbon dioxide equivalent (CO2e), were estimated for asthma-related medication use, HCRU and exacerbations during follow-up of patients with asthma classified at baseline as well-controlled (<3 short-acting ß2-agonist (SABA) canisters/year and no exacerbations) or poorly controlled (≥3 SABA canisters/year or ≥1 exacerbation). Excess GHG emissions due to suboptimal asthma control included ≥3 SABA canister prescriptions/year, exacerbations and any general practitioner and outpatient visits within 10 days of hospitalisation or an emergency department visit. RESULTS: Of the 236 506 patients analysed, 47.3% had poorly controlled asthma at baseline. Scaled to the national level, the overall carbon footprint of asthma care in the UK was 750 540 tonnes CO2e/year, with poorly controlled asthma contributing excess GHG emissions of 303 874 tonnes CO2e/year, which is equivalent to emissions from >124 000 houses in the UK. Poorly controlled versus well-controlled asthma generated 3.1-fold higher overall and 8.1-fold higher excess per capita carbon footprint, largely SABA-induced, with smaller contributions from HCRU. CONCLUSIONS: These findings suggest that addressing the high burden of poorly controlled asthma, including curbing high SABA use and its associated risk of exacerbations, may significantly alleviate asthma care-related carbon emissions.

Use of inhaled corticosteroids and the risk of hospitalisation for pneumonia in children with asthma: a nationwide cohort study.

BACKGROUND: The potential association between the use of inhaled corticosteroids (ICS) and the risk of pneumonia among adults is disputed and paediatric-specific evidence is scarce. AIM: To assess the potential association between ICS, use and the risk of hospitalisation for pneumonia among children (age 2-17 years) with asthma. METHODS: This was a cohort study based on nationwide data from routine clinical practice in Sweden (January 2007 to November 2021). From 425 965 children with confirmed asthma, episodes of new ICS use and no use were identified using records of dispensed drugs. We adjusted for potential confounders with propensity score overlap weighting and the risk of a hospitalisation with pneumonia as primary diagnosis was estimated. Multiple subgroup and sensitivity analyses were also performed. RESULTS: We identified 249 351 ICS (mean follow-up of 0.9 years) and 214 840 no-use (mean follow-up of 0.7 years) episodes. During follow-up, 369 and 181 events of hospitalisation for pneumonia were observed in the ICS and no-use episodes, respectively. The weighted incidence rates of hospitalisation for pneumonia was 14.5 per 10 000 patient-years for ICS use episodes and 14.6 for no-use episodes. The weighted HR for hospitalisation for pneumonia associated with ICS use was 1.06 (95% CI 0.88 to 1.28) and the absolute rate difference was -0.06 (95% CI -2.83 to 2.72) events per 10 000 patient-years, compared with no use. CONCLUSIONS: In this nationwide cohort study, we found no evidence of an association between ICS use and the risk of hospitalisation for pneumonia among children with asthma, as compared with no use.

Wireless Alerts and Data Monitoring from BNNO-MWCNTs/PDMS Composite Film-Based TENG Integrated Inhaler for Smart Healthcare Application.

In recent years, the implementation of energy-harvesting technology in medical equipment has attracted significant interest owing to its potential for self-powered and smart healthcare systems. Herein, the integration of a triboelectric nanogenerator (TENG) is proposed into an inhaler for energy-harvesting and smart inhalation monitoring. For this initially, barium sodium niobium oxide (Ba2NaNb5O15) microparticles (BNNO MPs) are synthesized via a facile solid-state synthesis process. The BNNO MPs with ferroelectricity and high dielectric constant are incorporated into polydimethylsiloxane (PDMS) polymer to make BNNO/PDMS composite films (CFs) for TENG fabrication. The fabricated TENG is operated in a contact-separation mode, and its electrical output performance is compared to establish the optimal BNNO MPs concentration. Furthermore, multi-wall carbon nanotubes (MWCNTs), a conductive filler material, are used to enhance the electrical conductivity of the CFs, thereby improving the electrical output performance of the TENG. The robustness/durability of the proposed BNNO-MWCNTs/PDMS CF-based TENG are investigated. The proposed TENG device is demonstrated to harvest electrical energy from mechanical motions via regular human activities and power portable electronics. The TENG is integrated into the inhaler casing to count the number of sprays remaining in the canister, send the notification to a smartphone via Bluetooth, and harvest energy.

Inhaler Steroid Use Changes Oral and Airway Bacterial and Fungal Microbiome Profile in Asthma Patients.

INTRODUCTION: The full spectrum of bacterial and fungal species in adult asthma and the effect of inhaled corticosteroid use is not well described. The aim was to collect mouthwash and induced sputum samples from newly diagnosed asthma patients in the pretreatment period and in chronic asthma patients while undergoing regular maintenance inhaled corticosteroid therapy, in order to demonstrate the bacterial and fungal microbiome profile. METHODS: The study included 28 asthmatic patients on inhaler steroid therapy, 25 steroid-naive asthmatics, and 24 healthy controls. Genomic DNA was isolated from induced sputum and mouthwash samples. Analyses were performed using bacterial primers selected from the 16S rRNA region for the bacterial genome and "panfungal" primers selected from the 5.8S rRNA region for the fungal genome. RESULTS: Dominant genera in mouthwash samples of steroid-naive asthmatics were Neisseria, Haemophilus, and Rothia. The oral microbiota of asthmatic patients on inhaler steroid treatment included Neisseria, Rothia, and Veillonella species. Abundant genera in induced sputum samples of steroid-naive asthma patients were Actinomyces, Granulicatella, Fusobacterium, Peptostreptococcus, and Atopobium. Sputum microbiota of asthma patients taking inhaler steroids were dominated by Prevotella and Porphyromonas. Mucor plumbeus and Malassezia restricta species were abundant in the airways of steroid-naive asthma patients. Choanephora infundibulifera and Malassezia restricta became dominant in asthma patients taking inhaled steroids. CONCLUSION: The oral and airway microbiota consist of different bacterial and fungal communities in healthy and asthmatic patients. Inhaler steroid use may influence the composition of the oral and airway microbiota.

Pediatric Asthma Inhaler Technique: Quality and Content Analysis of YouTube Videos.

This study aims to analyze the quality, reliability, and content of YouTube videos on pediatric asthma inhaler techniques both for parents and children. The study has a descriptive, retrospective, and cross-sectional design. The research was conducted by searching YouTube using the "Pediatric Metered Dose Inhaler," "Pediatric Accuhaler," and "Pediatric Diskus." The video's popularity was measured using the Video Power Index. The quality and reliability of the videos were evaluated using the modified DISCERN and Global Quality Scale (GQS). This study analyzed 55 YouTube videos on the pediatric inhaler technique. In total, 19 of the videos were related to the pressurized metered dose inhalers (pMDI) with a spacer for tidal breathing, 14 pMDI inhalers with a spacer for single breath, and 22 diskus devices. Findings show that videos demonstrating the use of pMDI devices for single breath have more reliable modified DISCERN scores. However, videos related to tidal breathing are more popular than those showing the use of diskus devices and pMDI single breath. Based on the checklist for videos on diskus devices, the steps with the highest error rates are 'Check dose counter' at 72.7% and 'Breathe out gently, away from the inhaler' at 63.6%. A moderate correlation was observed between the modified DISCERN score and the GQS. While YouTube videos on the pMDI single-breath technique may be useful for pediatric patients and caregivers, it is crucial for them to receive inhaler technique education from their healthcare provider. This study's findings hold great significance for pediatric patients and caregivers, particularly those who rely on YouTube for health-related information.

Evaluation of the quality and content of YouTube videos as an educational resource in developing patients' inhaler use skills.

BACKGROUND: YouTube has educational videos on inhalers. However, their content and quality are not adequately known. OBJECTIVES: This study investigated the quality and content of educational YouTube videos on inhalers. METHODS: This descriptive study analyzed 178 YouTube videos on inhalers between May and July 2022. Two researchers independently evaluated the videos. The Global Quality Score (GQS), Journal of American Medical Association (JAMA) Benchmark Criteria, and Inhaler Application Checklist (IAC) were used to assess the quality and content of the videos. Spearman's correlation, Kruskal-Wallis, Mann-Whitney U, ANOVA, and Post hoc analysis Bonferroni test were used for data analysis. RESULTS: The videos had a mean GQS score of 3.70 ± 1.24, and JAMA score of 2.22 ± 0.60. A negative correlation was between the quality score of the videos and views, likes, comments, duration, and likes/views (respectively; r = -0.237 p < 0.005, r = -0.217 p < 0.003, r = -0.220 p < 0.005, r = -0.147, p < 0.005). The videos narrated by nurses and doctors had significantly higher mean JAMA and GQS scores than others (p = 0.001). The videos missed some procedural steps [gargling (29.1%), adding no more than five ml of medication and device cleaning (41.9%), and exhaling through the nose (37.5%)]. Videos uploaded by individual missed significantly more procedural steps than professional organizations (p < 0.05). CONCLUSIONS: YouTube videos about inhaler techniques have a moderate level of quality. Videos uploaded by doctors and nurses as content narrators were of higher quality. The videos missed some procedural steps. Individual video uploaders had higher missed procedural steps. Counseling should be provided to patients regarding the reliability of online information.

Correlation of vitamin D receptor genotypes, specific IgE levels and other variables with asthma control in children.

INTRODUCTION: Asthma is a common condition affecting millions of children globally. The main goal of this study is to assess factors related to asthma management, particularly atopy level and the impact of genetic variants of the vitamin D receptor (VDR) gene. METHODS: Asthmatic children were enrolled in an outpatient respiratory clinic. Information on patients' medication adherence, medical and medication factors, and sociodemographic were gathered. Spirometry FEV1% and FVC% measurements, and the asthma control test were used to evaluate the severity of asthma, and genotyping of the VDR gene and radioallergosorbent test (RAST) were conducted. Regression analyses were conducted to evaluate variables associated with asthma control and spirometry measures. RESULTS: A total of 313 participants (67.4% males) were recruited in the current study. The mean age was 9.37 (±3.45) years. The mean score for adherence was 4.26 (±2.52), and only 46% of the participants had controlled asthma. Forward conditional stepwise binary regression showed that low and moderate Inhaled corticosteroids (ICS) dose (OR= 0.42 (95% CI 0.20-0.90), p = 0.026; OR = 0.371 (95% CI 0.2-0.72), p = 0.003, respectively) decreased the odds of being in the controlled asthma group, while higher inhaler score (OR = 2.75 (95% CI 2.17-3.49, p < 0.001)) increased the odds of being in the controlled asthma group. However, results found no association between VDR genotype and asthma control, spirometry values or hospitalization due to asthma. CONCLUSIONS: The results indicated that many of the asthma patients had poorly controlled asthma. Factors that were associated with poor asthma control included poor inhaler technique.

Adherence to single inhaler triple therapy and digital inhalers in Chronic Obstructive Pulmonary Disease: a literature review and protocol for a randomized controlled trial (TRICOLON study).

BACKGROUND: Medication non-adherence is a significant problem in patients with Chronic Obstructive Pulmonary Disease (COPD). Efforts to address this issue are receiving increased attention. Simplifying treatment by prescribing single-inhaler triple therapy (SITT) as an alternative to multi-inhaler triple therapy (MITT) or with smart inhalers are often considered potential solutions. However, the actual impact of these innovations on adherence and clinical outcomes is unclear. METHODS: To address this knowledge gap we first conducted a literature review focusing on two research questions: 1) the difference in adherence between SITT and MITT users in COPD, and 2) the effect of smart inhalers on adherence in COPD. Separate searches were conducted in PubMed and two authors independently assessed the articles. In addition, we present a protocol for a study to acquire knowledge for the gaps identified. RESULTS: To address the first research question, 8 trials were selected for further review. All trials were observational, i.e. randomized controlled trials were lacking. Seven of these trials showed higher adherence and/or persistence in patients on SITT compared with patients on MITT. In addition, four studies showed a positive effect of SITT on various clinical outcomes. For the second research question, 11 trials were selected for review. While most of the studies showed a positive effect of smart inhalers on adherence, there was considerable variation in the results regarding their effect on other clinical outcomes. The TRICOLON (TRIple therapy COnvenience by the use of one or multipLe Inhalers and digital support in ChrONic Obstructive Pulmonary Disease) trial aims to improve understanding regarding the effectiveness of SITT and smart inhalers in enhancing adherence. This open-label, randomized, multi-center study will enroll COPD patients requiring triple therapy at ten participating hospitals. In total, 300 patients will be randomized into three groups: 1) MITT; 2) SITT; 3) SITT with digital support through a smart inhaler and an e-health platform. The follow-up period will be one year, during which three methods of measuring adherence will be used: smart inhaler data, self-reported data using the Test of Adherence to Inhalers (TAI) questionnaire, and drug analysis in scalp hair samples. Finally, differences in clinical outcomes between the study groups will be compared. DISCUSSION: Our review suggests promising results concerning the effect of SITT, as opposed to MITT, and smart inhalers on adherence. However, the quality of evidence is limited due to the absence of randomized controlled trials and/or the short duration of follow-up in many studies. Moreover, its impact on clinical outcomes shows considerable variation. The TRICOLON trial aims to provide solid data on these frequently mentioned solutions to non-adherence in COPD. Collecting data in a well-designed randomized controlled trial is challenging, but the design of this trial addresses both the usefulness of SITT and smart inhalers while ensuring minimal interference in participants' daily lives. TRIAL REGISTRATION: NCT05495698 (Clinicaltrials.gov), registered at 08-08-2022. Protocol version: version 5, date 27-02-2023.

Asthma medication adherence, control, and psychological symptoms: a cross-sectional study.

BACKGROUND: Nonadherence to therapies and psychological disorders are associated with poor asthma control. This study aims to assess the prevalence of anxiety and depressive symptoms, asthma control, and adherence to inhalers and to investigate whether there is an association of anxiety and depressive symptoms with adherence to inhalers and asthma control. METHODS: We measured anxiety and depressive symptoms using the Hospital Anxiety and Depression Scale in patients with asthma. Asthma Control Test and the 10-Item Test of Adherence to Inhalers Scale were used to assess levels of asthma control adherence to inhalers, respectively. Univariate and multivariate regression models assessed the associations of anxiety and depressive symptoms with adherence to inhalers and asthma control. RESULTS: A total of 287 patients completed the study, of whom 72% were female. The mean ± SD age and body mass index of our study population were 44 ± 13 years and 29 ± 7.2 kg/m2, respectively. Poor adherence to inhaler use was highly prevalent (49.8%; 95% CI: 43.8 to 55.7). The prevalence of anxiety, depression and poor asthma control was 27.2% (95% CI: 22.1 to 32.7), 20.9% (95% CI: 16.3 to 26.1), and 22.7% (95% CI: 17.9 to 27.9), respectively. We found a negative relationship between asthma control and anxiety, and depressive symptoms (adjusted ß: -0.25; 95% CI: -0.36 to -0.14; p < 0.001 and adjusted ß: -0.29; 95% CI: -0.40 to -0.18; p < 0.001, respectively). A negative relationship was also observed between adherence to inhalers and anxiety and depressive symptoms (adjusted ß: -0.34; 95% CI: -0.46 to -0.22; p < 0.001 and adjusted ß: -0.36; 95% CI: - 0.48 to - 0.24; p < 0.001, respectively). CONCLUSIONS: The high prevalence of uncontrolled asthma symptoms and poor adherence to inhalers and their impact on anxiety and depression levels among patients with asthma point to the need for early screening for psychological symptoms and recognition of nonadherence as part of asthma assessment and management plan in primary care in Saudi Arabia to avoid further worsening of asthma symptoms. Further studies are needed to explore the effectiveness of specific psychoeducational interventions and investigate the long-term impact of early psychological symptom detection on asthma outcomes.

The Nonclinical Assessment of Trans-1,3,3,3-tetrafluoropropene (HFO-1234ze (E)), a Near Zero Global Warming Potential Propellant for Use in Metered Dose Inhalation Products.

HFO-1234ze (E) is proposed as a near zero global warming propellant for use in metered dose inhaled (MDI) products. This paper describes the non-clinical safety assessment in mice, rats, and dogs and supplements previously reported data (genetic toxicology, short-term toxicology, and reproductive toxicology). In all species, HFO-1234ze (E) was only detectable in blood for a short period after dosing with no evidence of accumulation. HFO-1234ze (E) was without any toxicological effects at very high doses in subchronic (13-week mouse) and chronic (39-week dog) studies. Chronic (26-week) administration to rats at very high doses was associated with an exacerbation of rodent progressive cardiomyopathy, a well-documented background finding in rodents. In a 2-generation study, extremely high doses were associated with the early euthanasia of some lactating female rats. This finding was considered to be significantly influenced by a state of negative energy balance, reflecting the specific vulnerability of rats during lactation. These findings are considered to not pose a risk to humans with typical MDI use given they occurred at doses which far exceed those expected in patients. Overall, the nonclinical safety data for HFO-1234ze (E) support its further development as an MDI propellant.

Quality by Design in Pulmonary Drug Delivery: A Review on Dry Powder Inhaler Development, Nanotherapy Approaches, and Regulatory Considerations.

Dry powder inhalers (DPIs) are state-of-the-art pulmonary drug delivery systems. This article explores the transformative impact of nanotechnology on DPIs, emphasizing the Quality Target Product Profile (QTPP) with a focus on aerodynamic performance and particle characteristics. It navigates global regulatory frameworks, underscoring the need for safety and efficacy standards. Additionally, it highlights the emerging field of nanoparticulate dry powder inhalers, showcasing their potential to enhance targeted drug delivery in respiratory medicine. This concise overview is a valuable resource for researchers, physicians, and pharmaceutical developers, providing insights into the development and commercialization of advanced inhalation systems.

Real-Time Particle Emission Monitoring for the Non-Invasive Prediction of Lung Deposition via a Dry Powder Inhaler.

Although inhalation therapy represents a promising drug delivery route for the treatment of respiratory diseases, the real-time evaluation of lung drug deposition remains an area yet to be fully explored. To evaluate the utility of the photo reflection method (PRM) as a real-time non-invasive monitoring of pulmonary drug delivery, the relationship between particle emission signals measured by the PRM and in vitro inhalation performance was evaluated in this study. Symbicort® Turbuhaler® was used as a model dry powder inhaler. In vitro aerodynamic particle deposition was evaluated using a twin-stage liquid impinger (TSLI). Four different inhalation patterns were defined based on the slope of increased flow rate (4.9-9.8 L/s2) and peak flow rate (30 L/min and 60 L/min). The inhalation flow rate and particle emission profile were measured using an inhalation flow meter and a PRM drug release detector, respectively. The inhalation performance was characterized by output efficiency (OE, %) and stage 2 deposition of TSLI (an index of the deagglomerating efficiency, St2, %). The OE × St2 is defined as the amount delivered to the lungs. The particle emissions generated by four different inhalation patterns were completed within 0.4 s after the start of inhalation, and were observed as a sharper and larger peak under conditions of a higher flow increase rate. These were significantly correlated between the OE or OE × St2 and the photo reflection signal (p < 0.001). The particle emission signal by PRM could be a useful non-invasive real-time monitoring tool for dry powder inhalers.

Using Dry Dispersion Laser Diffraction to Assess Dispersibility in Spheronized Agglomerate Formulations.

In this study, dry dispersion laser diffraction was used to study the dispersibility of spheronized agglomerate formulations and identify geometric particle size metrics that correlated well with aerodynamic particle size distribution (APSD). Eleven unique batches of agglomerates were prepared for both laser diffraction and cascade impaction testing. Correlations between the particle size distribution (PSD) and aerodynamic particle size distribution (APSD) metrics for the eleven agglomerate batches were determined in a semi-empirical manner. The strongest correlation between APSD and PSD was observed between the impactor-sized mass (%ISM) and the cumulative PSD fraction <14.5 µm. The strongest correlation with fine particle fraction (FPF) was observed with the cumulative PSD fraction <0.99 micron (R-squared = 0.974). In contrast to the other APSD metrics, good correlations were not found between the mass median aerodynamic diameter (MMAD) and the cumulative PSD fractions. Overall, the implementation of laser diffraction as a surrogate for cascade impaction has the potential to streamline product development. Laser diffraction measurements offer savings in labor and turnaround time compared to cascade impaction.

A comparative evaluation of the effects of respiratory diseases on dental caries.

PURPOSE: The aim of this study is to evaluate the susceptibility of patients suffering from asthma and chronic obstructive pulmonary disease (COPD) to dental caries by analyzing the physical, chemical, and microbiological characteristics of saliva, which are influenced by the medications they use. METHODS: A cohort of 104 individuals, spanning from 18 to 70 years of age, underwent a meticulous categorization based on their unique medical profiles and prescribed medication routines. Subsequently, a comprehensive evaluation was conducted to elucidate potential risk factors associated with dental caries. Alongside the assessment of decayed, missing, and filled teeth (DMFT index), decayed, missing, and filled surfaces (DMFS index), and Green and Vermillion Oral Hygiene Index-Simplified (G&V OHI-S) values, measurements were performed to gauge salivary flow rate, buffering capacity, and the presence of S. mutans, L. casei, S. aureus, and C. albicans. The acquired data were then inputted into the Cariogram software, enabling the derivation of personalized caries risk profiles for each individual. RESULTS: The diseased group exhibited significantly elevated levels of DMFT, DMFS, and G&V OHI-S values in comparison to the control group (p < 0.01). Moreover, the caries risk levels derived from the Cariogram were found to be significantly higher in patients diagnosed with asthma and COPD (p < 0.01). Notably, no substantial distinction was observed between these two experimental groups. Furthermore, it was discerned that COPD patients utilizing two or three distinct medications did not display any discernible variation in terms of their susceptibility to dental caries (p > 0.05). CONCLUSION: Asthma and COPD patients exhibit an increased susceptibility to dental caries as a result of their medication regimens. Hence, it is highly advisable for these individuals to demonstrate heightened vigilance in terms of oral hygiene practices and seek regular dental check-ups for continuous monitoring and preventive care.

[Rate of Correct Inhaler Usage and Related Factors in Elderly Patients With Chronic Obstructive Pulmonary Disease].

BACKGROUND: Poor disease control in patients with chronic obstructive pulmonary disease (COPD) is associated with suboptimal inhaler use. PURPOSE: This study was designed to explore the accuracy of inhaler use and related factors in elderly patients with COPD. METHODS: A cross-sectional survey design was used to recruit patients with COPD from a medical centre in southern Taiwan who were over 65 years old and used inhalers regularly. All of the data as well as information on inhaler use accuracy were collected using a self-designed questionnaire and inhaler operation checklist. Multivariable logistic regression was used to analyse significant correlates of correct inhaler operation. RESULTS: The average age of the 150 participants was 75.0 years (SD = 7.5) years. Most used one type of inhaler only (86.0%). The rate of accurate inhaler operation was 40.7% (n = 61) for the sample, with dry powder inhalers associated with the highest accuracy (64%) and pressurized metered-dose inhalers associated with the lowest accuracy (1.6%). Multivariate logistic regression analysis showed that using a soft mist inhaler (adjusted odds ratio, AOR = 23.29; 95% confidence interval, 95% CI [2.84, 191.07]), using a dry powder inhaler (AOR =15.60, 95% CI [1.99, 122.26]), and higher satisfaction with the inhaler were positively and independently associated with accurate inhaler use (AOR = 1.94, 95% CI [1.09, 3.44]). CONCLUSIONS / IMPLICATIONS FOR PRACTICE: Important factors related to inhaler use accuracy include inhaler type and level of patient satisfaction with their inhaler. Healthcare professionals should regularly confirm that older patients are able to use their inhalers correctly and are satisfied with their inhalers.

Factors affecting asthma control in pregnancy: A cross-sectional study.

Background and Objective: Asthma control in pregnant women remains of utmost importance; suboptimal control can have adverse repercussions on both fetal and maternal health. The objective was to identify the factors that affect asthma control in pregnant Pakistani women presenting to a tertiary care hospital. Methods: This descriptive, cross-sectional research was conducted at KRL General Hospital between 1st November 2022 to 30th April 2023. Non-probability technique was used to sample one hundred and forty-five pregnant women with confirmed bronchial asthma irrespective of their trimester presented. Data regarding demographics and factors affecting asthma control was collected. Results: The mean age was 30.39 ± 4.33 years, with two-thirds (65%) being multiparous. Approximately 48% of participants were non-compliant with treatment, and less than 40% achieved adequate asthma control. A chi-squared test applied showed that multiparity (p = 0.003), treatment compliance (p < 0.001), BMI (p < 0.001), and proper inhaler technique (p < 0.001) were statistically significant factors affecting asthma control in pregnant women while, the level of education and household income did not exhibit a significant association. Multiple regression analysis qualified higher BMI, multiparity, treatment compliance, and inhaler technique as significant predictors of asthma control amongst pregnant women. Conclusion: Ensuring asthma control during pregnancy is important. This study identified BMI, multiparity, inhaler technique, and treatment compliance as factors that affect asthma control in pregnant women. Addressing these factors through regular antenatal check-ups can significantly mitigate risks and promote the optimal health of both maternal and fetal lives.

Effect of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler combined with nasal high-flow nasal cannula on elderly patients with COPD and respiratory failure.

Objective: To explore the clinical effect of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) combined with high-flow nasal cannula (HFNC) in the treatment of elderly patients with chronic obstructive pulmonary disease (COPD) and respiratory failure. Methods: The clinical records of 94 elderly patients with COPD and respiratory failure who were treated in Yongkang First People's Hospital from February 2022 to January 2023 were retrospectively selected. Among them, 46 patients received HFNC alone (Control-group) and 48 patients received HFNC combined with BGF MDI (Study-group). The treatment effect, arterial blood gas status, pulmonary function, and acute physiology and chronic health evaluation (APACHE) II score before and after treatment were analyzed in both groups. Results: The total efficacy of treatment in the Study-group (95.8%) was higher than that in the Control-group (78.3%) (P<0.05). After treatment, the partial pressure of arterial carbon dioxide (PaCO2), residual volume, and APACHE II scores in the two groups decreased compared to those before treatment, with the Study-group lower overall. However, arterial oxygen saturation (SaO2), oxygen partial pressure (PaO2), the percentage of peak expiratory flow (PEF), and forced expiratory volume in one second (FEV1) as percent of predicted (%FEV1) were higher than before treatment, and higher in the Study-group (P<0.05). Conclusions: Compared with HFNC alone, BGF MDI combined with HFNC can effectively regulate the arterial blood gas status of elderly patients with COPD and respiratory failure, restore pulmonary function, and improve the overall treatment effect.

Can single-inhaler Beclometasone Dipropionate/Formoterol Fumarate/Glycopyrronium therapy postpone or save biologics for severe asthma?

Inhaled corticosteroids, along with beta2-agonists and anti-muscarinics, represent the cornerstone of asthma treatment. Although the advent of monoclonal antibodies has dramatically changed severe asthma management, there are still patients ineligible or with poor response to biologics. Moreover, high costs associated with monoclonal antibodies prescription are still an open issue, leading clinicians to carefully assess cost-benefit ratio before their administration. From this perspective, the use of single-inhaler Beclometasone Dipropionate/Formoterol Fumarate/Glycopyrronium in patients with severe asthma could not only improve their clinical and functional performance, but also postpone biologic prescription, with positive repercussions on healthcare costs.

Relative bioavailability of budesonide/glycopyrrolate/formoterol fumarate triple therapy delivered using next generation propellants with low global warming potential.

INTRODUCTION: The climate crisis poses an immediate threat to human health and well-being, demanding urgent adaptions across sectors, including healthcare. The development of pressurized metered dose inhalers (MDIs) with greater sensitivity to the climate emergency using novel propellants with lower global warming potentials (GWPs), but comparable pharmacokinetic (PK) parameters to currently marketed MDIs, is a vital step toward reducing the impact of healthcare for respiratory disorders on climate change. This study evaluated the relative bioavailabilities of the individual components of a fixed-dose combination of budesonide/glycopyrrolate/formoterol fumarate (BGF) 160/9/4.8 µg per actuation between three different propellant formulations. METHODS: Healthy male participants (aged 18-60 years) were randomized into a single-blind, three-period, single-dose, single-center, crossover study (NCT04600505). The PK and safety and tolerability profiles of BGF MDI formulated with two novel propellants with low GWP (hydrofluoroolefin-1234ze [HFO]; hydrofluorocarbon-152a [HFC]) were compared with BGF MDI formulated with the propellant used in the currently marketed reference product (hydrofluoroalkane-134a [HFA]). The study included a screening period, three treatment periods (with 3- to 7-day washout periods between each dose), and a follow-up. The primary PK parameters assessed were maximum observed plasma concentration (Cmax), area under the plasma concentration curve (AUC) from time zero extrapolated to infinity (AUCinf), and AUC from time zero to the time of the last quantifiable analyte concentration (AUClast). The study was not powered to statistically demonstrate bioequivalence. RESULTS: Forty-seven participants completed the study, and 24 participants were evaluable for PK assessments. Systemic exposure, based on geometric mean ratios (90% confidence interval), to each BGF component from the test propellants delivered in a standard MDI was comparable with the reference propellant for AUClast (HFO vs. HFA: budesonide, 107.30 [94.53, 121.90]; glycopyrrolate, 106.10 [86.18, 130.60]; formoterol, 98.13 [86.44, 111.40]; HFC vs. HFA: budesonide, 98.80 [84.59, 115.40]; glycopyrrolate, 99.71 [80.84, 123.00]; formoterol, 107.00 [88.82, 128.90]); AUCinf (where evaluable) and Cmax followed the same trend. There were no serious adverse events or adverse events leading to treatment discontinuation. No new safety signals were observed. CONCLUSIONS: Systemic BGF component exposure was similar for both test propellants (HFO and HFC) compared with the HFA reference propellant, with an acceptable safety profile in the studied population. Therefore, both novel low GWP propellants show strong potential as candidates for development of MDIs with greater sensitivity to the climate crisis, a vital step toward ameliorating the detrimental impact of healthcare on the environment. Further investigation in larger studies is warranted.

Near Elimination of In Vitro Predicted Extrathoracic Aerosol Deposition in Children Using a Spray-Dried Antibiotic Formulation and Pediatric Air-Jet DPI.

PURPOSE: This study evaluated the in vitro aerosol performance of a dry powder antibiotic product that combined a highly dispersible tobramycin powder with a previously optimized pediatric air-jet dry powder inhaler (DPI) across a subject age range of 2-10 years. METHODS: An excipient enhanced growth (EEG) formulation of the antibiotic tobramycin (Tobi) was prepared using a small particle spray drying technique that included mannitol as the hygroscopic excipient and trileucine as the dispersion enhancer. The Tobi-EEG formulation was aerosolized using a positive-pressure pediatric air-jet DPI that included a 3D rod array. Realistic in vitro experiments were conducted in representative airway models consistent with children in the age ranges of 2-3, 5-6 and 9-10 years using oral or nose-to-lung administration, non-humidified or humidified airway conditions, and constant or age-specific air volumes. RESULTS: Across all conditions tested, mouth-throat depositional loss was < 1% and nose-throat depositional loss was < 3% of loaded dose. Lung delivery efficiency was in the range of 77.3-85.1% of loaded dose with minor variations based on subject age (~ 8% absolute difference), oral or nasal administration (< 2%), and delivered air volume (< 2%). Humidified airway conditions had an insignificant impact on extrathoracic depositional loss and significantly increased aerosol size at the exit of a representative lung chamber. CONCLUSIONS: In conclusion, the inhaled antibiotic product nearly eliminated extrathoracic depositional loss, demonstrated high efficiency nose-to-lung antibiotic aerosol delivery in pediatric airway models for the first time, and provided ~ 80% lung delivery efficiency with little variability across subject age and administered air volume.