Inhaled Corticosteroids Research Articles

Identifying the predictive value of fractional exhaled nitric oxide (FeNO) for uncontrolled asthma in 3-7-year-old Thai children.

Fractional exhaled nitric oxide (FeNO) is the method for monitoring airway inflammation. However, a singular FeNO value cutoff may not adequately represent the control status across different ages and demographics. This study aimed to evaluate the correlation between FeNO values and asthma control levels, identifying an optimal cutoff point for children aged 3 to 7 years. This cross-sectional study was conducted at Naresuan University Hospital from April 1, 2023 to July 31, 2023. Inclusion criteria were asthmatic patients aged 3 to 7 years who were capable of following commands. Exclusion criteria included children who had a coronavirus disease 2019 (COVID-19) infection, those experiencing difficulty breathing, or unable to perform the FeNO measurement. Eligible patients were classified according to their level of asthma control and underwent FeNO testing. Out of 108 participants who successfully completed FeNO measurements, a significant difference in FeNO values was observed across controlled, partially controlled, and uncontrolled asthma groups, with uncontrolled asthma presenting significantly higher values. The optimal FeNO cutoff point for predicting uncontrolled asthma was identified as ≥15 ppb with a sensitivity 46.7%, specificity 86.0%, positive predictive value (PPV) 35.0%, negative predictive value (NPV) 90.9%. This study established a significant correlation between FeNO levels and uncontrolled asthma, FeNO cutoff point ≥15 ppb as the optimal value in predicting uncontrolled asthma in Thai children aged 3-7 years. Factors such as uncontrolled allergic rhinitis, symptoms at onset, smoking exposure, treatment compliance, and inhaled corticosteroid (ICS) usage were associated with FeNO values. The application of FeNO measurement should be integrated with clinical assessments and consideration of these associated factors.

Bronchial asthma with normal forced expiratory volume in 1 second (FEV1) compared with low FEV1.

Cough variant asthma (CVA) is characterized by cough as a sole symptom and normal pulmonary function. However, it is unclear whether CVA really common among asthmatic patients with normal forced expiratory volume in 1 second (FEV1). The aim of this study was to evaluate the incidence of cough alone symptom among the subjects with normal FEV1 and to evaluate their differences from ordinary asthmatic subjects. We defined normal FEV1 as ≥90% predicted based on the article of Kotti GH. Of the patients with normal FEV1, we chose subjects without wheeze, and the duration of cough was not to ask, since the symptoms often occurred with acute exacerbation and timing of visiting a doctor depended on each patient's perception. Test for airway hyperresponsiveness was not performed in this study. Visual analogue scale (VAS) scores for cough and dyspnea, FEV1, and fractional exhaled nitric oxide (FeNO) responsiveness to inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) treatment were compared in patients with normal FEV1 and with low FEV1 <90%. Correlations of changes in symptoms with changes of FEV1, FeNO, peripheral eosinophil count, and serum immunoglobulin E (IgE) at single time point were also examined in each group and in overall patients. The participants were 329 physician-diagnosed treatment-naive patients with asthma who were divided into 187 in normal FEV1 and 142 in low FEV1 groups. Cough without dyspnea was present in 16 patients (8.6%) in the normal FEV1 group, suggesting candidates for CVA in this analysis were quite few. Improvement in symptoms after treatment was similar between both groups. But VAS scores of dyspnea were still higher in the low FEV1 group. The degree of improvement in FEV1 after ICS/LABA treatment was less in the normal FEV1 group than in the low FEV1 group, but was still evident. Peripheral eosinophil count, serum IgE, and FeNO values before treatment were lower in the normal FEV1 group. In overall patients, improvements of symptoms after treatment were significantly correlated with FEV1 changes. Improvement of dyspnea was also significantly related to peripheral eosinophil count and change of FeNO, whereas improvement of cough was not related to these T helper 2 (Th2) response markers. Candidates for CVA among the patients with asthma with predicted FEV1 ≥90% were few. Participants with normal FEV1 respond well to ICS/LABA treatment for improvement of symptom. The change of FEV1 after treatment, and the pre-treatment blood eosinophil count, serum IgE, and FeNO were lower in normal FEV1 cases than in low FEV1 cases. These observations suggest asthmatic patients with normal FEV1, including candidates for CVA having just common mild asthma. In overall participants, symptoms of cough and dyspnea were similar, but were not identical in relation to the Th2 background.

FLUTICASONE FUROATE AND VILANTEROL (FF/VI) VERSUS FLUTICASONE PROPRIONATE AND FORMOTEROL (FP/FM) AS MAINTENANCE THERAPY IN STABLE ASTHMATIC PATIENTS- A COMPARATIVE STUDY

Background: Fluticasone furoate (FF) is a novel long-acting inhaled corticosteroid (ICS). Vilanterol (VI) is a long‐acting beta2‐agonist (LABA) that binds to the beta2‐adrenoceptor on the airway smooth muscle, producing bronchodilation. The corticosteroid fluticasone propionate (FP)and the long-acting β₂-adrenoceptor agonist (LABA) formoterol fumarate (FM) have been combined in a single, pressurized, metered-dose, aerosol inhaler for the maintenance treatment of patients aged ≥12 years with persistent asthma.This study evaluated the efficacy and safety of Fluticasone furoate 100 mcgandVilanterol 6 mcg versus Fluticasone proprionate 250 mcg and Formoterol 25 mcg for 12 weeks in patients with persistent asthma as maintenance therapy. Methods and Materials: A hospital based comparative study was conducted among stable asthmatic patients attended to Santhiram Medical College and General Hospital, Nandyal during January 2024 to June 2024(6months) by using convenient sampling method with sample size 60. Study tool was pre-designed, pre-tested, asthma control questionnaire5 (ACQ5),asthma control test (ACT) and Ask 12 adherence barrier survey. Results: Among 60 patients, 30 patients (Group1) were given Fluticasone furoate and Vilanterol and another 30 patients (Group 2) were given Fluticasone proprionate and Formoterol. All the patients (both the treatment groups) completed the 12 weeks treatment period. Improvements from baseline in 0- to 24-h wmFEV1 were observed with both FF/VI (376 mL) and FP/FM (353 mL) the adjusted mean treatment difference was not statistically significant. There were no differences between 0- to 4-h serial wmFEV1, asthma control test, ACQ5 and Ask 12 adherence barrier survey. There was no difference in reported exacerbations between treatments. Adverse events reported in the present study were not significant. Both treatments were well tolerated. Conclusion: The present study shows that the efficacy of once daily Fluticasone furoate and Vilanterol was not inferior as compared to the efficacy of twice daily Fluticasone proprionate and Formoterol as maintenance therapy in stable asthmatic patients. Howevertreatment with once daily FF/VI has the advantage of forgetfulness and inconvenience of inhalation.Henceonce daily FF/VI can be also useful for stable asthmatic patients as maintenance therapy as FF/VI DPI treatment.

Exploring the Impact of Inhaled Corticosteroids on Endothelial Function in Chronic Obstructive Pulmonary Disease Patients Undergoing Pulmonary Rehabilitation.

Background: Chronic obstructive pulmonary disease (COPD) is associated with subclinical atherosclerosis and endothelial dysfunction, which can be assessed non-invasively through flow-mediated dilation (FMD). In this study, we evaluated the potential impact of inhaled corticosteroid (ICS) therapy on FMD of COPD patients undergoing pulmonary rehabilitation (PR). Methods: Medical records of COPD patients undergoing FMD assessment upon admission to our Pulmonary Rehabilitation Unit were reviewed in this retrospective post hoc analysis. Results: A total of 46 patients with COPD (median age 71.5 years, 28.3% postmenopausal females) were included in the final analysis. Among these, 27 participants were currently receiving ICS therapy, while 19 were not. At baseline, the two groups showed no difference in the main clinical and functional variables. Similarly, no significant difference was observed in vascular reactivity parameters, with a median FMD of 3.12% (IQR: 2.23-4.45) in ICS users and 3.39% (IQR: 2.45-4.08) in ICS nonusers (p = 0.544). After PR, a significant improvement in the main rehabilitation and patient-reported outcomes was observed in all groups, with a significant improvement in FMD documented in both patients treated with steroids (from 3.12%; IQR: 2.23-4.45 to 4.77%; IQR: 3.25-5.63, p = 0.022) and in those who were not (from 3.39%; IQR: 2.45-4.08 to 5.04%; IQR: 3.98-6.06, p = 0.005). FMD changes were of comparable magnitude among groups. Conclusions: Our preliminary findings do not indicate a significant impact of medications containing ICS on the endothelial function of COPD patients, suggesting that the potential beneficial effect of PR on this surrogate marker of cardiovascular risk is independent of inhaled therapy.

Inhaled budesonide and pulmonary sarcoidosis revisited.

Results of a few controlled clinical studies have been reported with inhaled corticosteroids (ICS) in patients with pulmonary sarcoidosis. Some evidence of efficacy has been observed, but mainly with the ICS budesonide (BUD). These clinically important and statistically significant results are restricted to maintenance therapy with BUD after induction of treatment with systemic corticosteroids for a few weeks or months. Positive results have also been described in patients with relapses after earlier treatment with oral corticosteroids. A possible explanation for BUD's efficacy in patients with parenchymal lesions could be that inhaled BUD is rapidly absorbed into systemic circulation, creating plasma peaks which result in systemic anti-inflammatory activity in both peripheral airways and lung tissue. At airway level this steroid activity is furthermore prolonged because a BUD fraction is intracellularly, reversibly transformed into lipophilic BUD-oleate. These mechanisms have been proposed to explain the theoretically unexpected similar efficacy of BUD compared with more lipophilic ICSs in patients with asthma and COPD. In this review we summarize the results of clinical studies with ICSs in patients with pulmonary sarcoidosis. It is obvious that current ICSs, including BUD, cannot generally be recommended as such for treatment of sarcoidosis. However, using BUD as a model substance further pharmacologic and kinetic studies could possibly define a kinetic profile giving optimal partitioning between airway and systemic activity with less adverse systemic risks. Such a substance could replace or reduce oral corticosteroids in the treatment of airway and pulmonary parenchymal diseases.

Asthma control and use of short-acting beta-2-agonists for symptom relief in Africa – A narrative review

More than 100 million people in Africa live with Asthma. With appropriate treatment, predominantly inhaled corticosteroids (ICSs), asthma is controllable in most people. However, in Africa, multiple factors constrain the accessibility, availability, and quality of asthma services, which lead to underdiagnosis and sub-optimal treatment of the disease. These constraints include weak healthcare systems and inadequate knowledge of healthcare providers on asthma diagnosis and treatment. There is also a poor awareness of asthma as a long-term disease in the general population. There are several myths and misconceptions about asthma as a disease. There is also poor access to ICSs, the most effective controller medicines for asthma. This is mostly due to the high cost. Furthermore, the non-use or delays in initiating treatment with inhaled steroids commonly leads to overuse and overreliance on rapid relievers of asthma symptoms, and in particular, short-acting beta-2-agonists (SABAs), both in oral and inhaled forms. This practice is very common and contributes to the sub-optimal treatment and resultant poor control of asthma, which is highly prevalent in Africa. In this paper, we highlight the burden of asthma in Africa, the effects of overuse/overreliance of SABA use on asthma control and provide suggestions to reduce the dependency on SABAs to improve asthma treatment and enhance asthma control on the African continent.

The Analysis Study of Comparison of Effectiveness and Safety of Inhalers in Mild-to Moderate Asthma in Adults: A Comprehensive Systematic Review

Background: Asthma, a prevalent and potentially debilitating chronic disease, is traditionally managed using reliever medications such as short-acting β2-agonists (SABA) or low-dose inhaled corticosteroids (ICS). Recent evidence, however, indicates that a combination of as-needed ICS and a rapid-acting long-acting β2-agonist (LABA) provides superior outcomes compared to SABA alone. Furthermore, this combination therapy is at least as effective as regular ICS in mitigating the risk of exacerbations. This emerging evidence highlights a significant shift in treatment strategies for mild asthma, underscoring the potential for enhanced management and improved patient outcomes with the new therapeutic approach. Methods: Following PRISMA 2020 guidelines, this systematic review focused exclusively on full-text articles published in English between 2014 and 2024. Result: The study conducted a comprehensive review of over 400 publications sourced from reputable databases, including ScienceDirect, SagePub, and PubMed. Folowing an initial screening, eight publications were identified as warranting more in-depth analysis. Conclusion: The study found that as-needed ICS/LABA is effective in preventing exacerbations in mild-to-moderate asthma patients, but less effective than regular ICS in improving FEV1 and ACQ scores. Combining ICS/LABA with SMART regimen was highest for severe exacerbations prevention.

Effect of low climate impact vs. high climate impact inhalers for patients with asthma and COPD-a nationwide cohort analysis

BackgroundChronic obstructive pulmonary disease (COPD) and asthma can be treated with inhaled corticosteroids (ICS) delivered by low climate impact inhalers (dry powder inhalers) or high climate impact inhalers (pressurized metered-dose inhalers containing potent greenhouse gasses). ICS delivered with greenhouse gasses is prescribed ubiquitously and frequent despite limited evidence of superior effect. Our aim was to examine the beneficial and harmful events of ICS delivered by low and high climate impact inhalers in patients with asthma and COPD.MethodsNationwide retrospective cohort study of Danish outpatients with asthma and COPD treated with ICS delivered by low and high climate impact inhalers. Patients were propensity score matched by the following variables; age, gender, tobacco exposure, exacerbations, dyspnoea, body mass index, pulmonary function, ICS dose and entry year. The primary outcome was a composite of hospitalisation with exacerbations and all-cause mortality analysed by Cox proportional hazards regression.ResultsOf the 10,947 patients with asthma and COPD who collected ICS by low or high climate impact inhalers, 2,535 + 2,535 patients were propensity score matched to form the population for the primary analysis. We found no association between high climate impact inhalers and risk of exacerbations requiring hospitalization and all-cause mortality (HR 1.02, CI 0.92–1.12, p = 0.77), nor on pneumonia, exacerbations requiring hospitalization, all-cause mortality, or all-cause admissions. Delivery with high climate impact inhalers was associated with a slightly increased risk of exacerbations not requiring hospitalization (HR 1.10, CI 1.01–1.21, p = 0.03). Even with low lung function there was no sign of a superior effect of high climate impact inhalers.ConclusionLow climate impact inhalers were not inferior to high climate impact inhalers for any risk analysed in patients with asthma and COPD.

Breathing for Two: Asthma Management, Treatment, and Safety of Pharmacological Therapy during Pregnancy.

The primary objectives of asthma management during pregnancy are to achieve adequate symptom control, reduce the risk of acute exacerbations, and maintain normal pulmonary function, all of which contribute to ensuring the health and well-being of both the mother and the baby. The Global Initiative for Asthma (GINA) recommends that pregnant women with asthma continue using asthma medications throughout pregnancy, as the benefits of well-controlled asthma for both the mother and fetus outweigh the potential risks of medication side effects, poorly controlled asthma, and exacerbations. The classification of asthma medications by the US Food and Drug Administration (FDA) into categories A, B, C, D, and X is no longer applied. Instead, the potential benefits and risks of each medication during pregnancy and lactation are considered individually. The use of medications to achieve good asthma control and prevent exacerbations during pregnancy is justified, encompassing inhaled corticosteroids (ICS), some leukotriene receptor antagonists (LTRA), short-acting beta-2 agonists (SABA), long-acting beta-2 agonists (LABA), short-acting muscarinic antagonists (SAMA), long-acting muscarinic antagonists (LAMA), and, recently, biological therapies, even in the absence of definitive safety data during pregnancy.

Is using inhaled corticosteroid effective against COVID-19 pneumonia severity and mortality?

It is known that the use of inhaled corticosteroids increases the incidence of pneumonia in patients followed up with the diagnosis of chronic asthma and chronic obstructive pulmonary disease (COPD). This study aimed to investigate the contribution of inhaled steroid use to pneumonia severity and mortality in cases with COVID-19 pneumonia. The study is a retrospective, observational study. Among the cases admitted to the pandemic clinic, patients diagnosed with COVID-19 pneumonia were included. The plan was to compare cases who received and did not receive inhaled corticosteroids in terms of pneumonia severity and mortality. In order to define risk factors for mortality, univariate and multivariable negative binomial regression analyses were performed. In our study, it was observed that n= 540 (75%) cases did not receive inhaled corticosteroids (group 1), and 180 (25%) cases used inhaled corti costeroids (group 2). Group 1 and group 2 cases were compared in terms of pneumonia severity with no significant difference between the two groups (p= 0.11). Then, risk factors affecting mortality in all cases were examined with univariate analyses. Increasing age, applying mechanical ventilation, having severe pneumonia, having interstitial lung disease, and applying prone position were found to be statistically significant factors in mortality (p < 0.05). In conclusion, in our study, it was observed that the use of inhaled corticosteroids did not increase the severity of pneumonia and mortality. It was thought that the treatment they received could be continued when the patients treated with inhaled corticosteroids due to asthma and COPD had COVID-19 pneumonia.

Effect of long-term inhaled corticosteroids therapy on cognitive function in patients with bronchial asthma and chronic obstructive pulmonary disease.

Inhaled corticosteroids (ICS) are prominent therapies for managing both asthma and chronic obstructive pulmonary disease (COPD). It has been noted that cognitive impairment is usually linked to high levels of corticosteroids in the blood. This investigation aims to ascertain how long-term inhaled corticosteroid treatment affects individuals with bronchial asthma and COPD's cognitive performance. A total of 139 inpatients diagnosed with COPD and bronchial asthma were enrolled in the study of which 43 were newly diagnosed (group 1), 34 were taking ICS for 0.5-1 year (group 2) and 62 were on long-term ICS, that is, for >2 years (group 3). Patients with a score of at least 24 were considered to have normal cognitive function as prescribed by the Montreal Cognitive Assessment scale. It was observed that 56 patients (90.3%) were on long-term ICS treatment, 25 patients (73.5%) were on intermediate therapy and 27 patients (62.7%) who were newly diagnosed had cognitive impairment. In conclusion, the duration of ICS therapy was significantly associated with a decline in cognitive function.

Elevated Fracture Risks in Patients Using Inhaled Corticosteroids: A Korean Nationwide Study.

In this comprehensive retrospective nationwide cohort study, we examined the relationships between various asthma medications and bone health, utilizing data from the National Health Insurance Service database of South Korea. From 2015 to 2019, the relevant dataset included 168,611 individuals aged 66 years, among whom 8,747 were diagnosed with asthma. We focused on a subset of 6,173 patients, all 66-year-old women. Participants were categorized into four groups: nonusers of asthma medication (n=2,868), leukotriene antagonist users (n=2,281), inhaled corticosteroid (ICS) users (n=517), and those using a combination of ICS and long-acting beta-agonist (ICS+LABA) medication (n=507). The primary outcomes measured were the incidences of major osteoporotic fractures and hip fractures during the follow-up period. Over 2.7 years of follow-up, 615 cases of major osteoporotic fractures and 96 cases of hip fractures were recorded. ICS users exhibited a heightened risk of both injuries, with hazard ratios of 1.38 (95% confidence interval [CI], 1.18 to 1.63; P<0.001) for major osteoporotic fractures and 1.56 (95% CI, 1.33 to 1.83; P<0.001) for hip fractures. Similarly elevated risks were observed in the ICS+LABA group. Notably, the risk associated with ICS was particularly pronounced among patients with osteopenia for both fracture types. Overall, the use of ICS, alone or in combination with LABA, in patients with asthma is associated with significantly increased risks of osteoporotic fractures, especially among those with osteopenia. These findings underscore the importance of considering bone health when managing asthma, especially in older patients and those with existing bone density issues.

Utility of exhaled nitric oxide to guide mild asthma treatment in atopic patients and its correlation with asthma control test score: a randomized controlled trial

BackgroundFractional exhaled nitric oxide (FeNO) is used for the diagnosis and monitoring of asthma, although its utility to guide treatment and its correlation with other tools is still under discussion. We study the possibility to withdraw inhaled corticosteroid treatment in atopic patients with mild asthma based on the FeNO level, as well as to study its correlation with other clinical control tools.MethodsProspective and randomized study including atopic patients aged 18 to 65 with mild asthma, stable, on low-dose inhaled corticosteroid (ICS) treatment, who had their treatment withdrawn based on a FeNO level of 40 ppb. Patients were randomized into two groups: control group (treatment with ICS was withdrawn regardless of FeNO level) and experimental group (according to the FeNO levels, patients were assigned to one of two groups: FeNO > 40 ppb on treatment with budesonide 200 mcg every 12 h and SABA on demand; FeNO ≤ 40 ppb only with SABA on demand). Follow-up was conducted for one year, during which medical assessment was performed with FeNO measurements, asthma control test (ACT), lung function tests (FEV1, FEV1/FVC, PEF, and RV/TLC), and recording of the number of exacerbations.ResultsNinety-two patients were included, with a mean age of 39.92 years (SD 13.99); 46 patients were assigned to the control group, and 46 patients to the experimental group. The number of exacerbations was similar between the groups (p = 0.301), while the time to the first exacerbation was significantly shorter in the control group (30.86 vs. 99.00 days), p < 0.001, 95% CI (43.332—92.954). Lung function tests (FEV1, FEV1/FVC, PEF, and RV/TLC) showed no differences between the groups (p > 0.05). Both FeNO and ACT showed significant changes in the groups in which ICS was withdrawn (p < 0.05 for both parameters). A significant negative correlation was observed between FeNO and ACT (r = -0.139, p = 0.008).ConclusionsIn atopic patients with mild asthma, withdrawal of ICS based on an FeNO of 40 ppb led to worsened symptoms but without changes in lung function tests or an increase in exacerbations. There was a negative correlation between FeNO values and symptomatic control measured by the ACT.Trial registrationClinical Trial Number: 2012–000372-42. Start Date: 2012–07-23. Trial registered prospectively (https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-000372-42). This study adheres to CONSORT guidelines of randomised control trials.

Effect of Long-Term Inhaled Corticosteroid Therapy on Metabolic And Anthropometric Parameters in Pediatric Patients with Asthma

Background: The long-term impact of inhaled corticosteroids (ICSs) metabolic parameters of asthmatic children is still uncertain. Objective: This study aimed to evaluate the effects of long-term use of ICSs on metabolic and anthropometric measures in children with asthma in Iran. Methods: This case-control study was conducted among 200 pediatric asthmatic patients who were referred to Abuzar Hospital (Ahvaz, Iran) during nine months. Demographic and clinical data of the patients were recorded. The participants were categorized into two groups: Group 1 (n = 100) comprising children with moderate to severe asthma, and Group 2 (n = 100) consisting of those with mild asthma. Results: The average age of 200 patients was 8.1 ± 2.9 years. The majority of them were male. The prevalence of wasting, stunting, obesity, and overweight was higher among Group 1 compared to Group 2 (p &lt; 0.05). Patients in Group 1 had significantly higher levels of calcium, vitamin D, lipids, and glycemic parameters than those in Group 2 (p &lt; 0.05). In addition, the duration of ICS use was notably longer in Group 1 (p &lt; 0.05). Conclusion: Children with moderate and severe asthma had significantly elevated lipid and glycemic parameters, as well as a higher prevalence of wasting, stunting, obesity, and overweight compared to patients with mild asthma. Further studies involving larger sample sizes and longer durations are necessary to confirm these findings.

Exploring the role of inhaled corticosteroid/betamethasone for managing recurrent respiratory illness in infants and young children

Background: Recurrent respiratory illnesses (RRIs) are frequent respiratory tract infections, particularly common in fall-winter and during seasonal changes. RRIs primarily affect children aged 2-7 years and the elderly, with respiratory viruses causing about 80% of cases. They interfere significantly with children's well-being and incur substantial medical and social costs. The study aim was to assess the effectiveness of inhaled corticosteroids (ICS) in infants and young children with recurrent respiratory symptoms. Methods: This prospective observational study took place over one year at the department of pediatrics, Cox’s Bazar medical college, Bangladesh, from June 1, 2014, to May 31, 2015. Results: The study involved 210 children with recurrent respiratory symptoms, mostly males (57.62%) and predominantly aged 1-3 years (55.71%). Atopy was present in 16.67%, and eczema in 30.48%. Only 2.38% of mothers smoked during pregnancy, and 20.48% of children were exposed to passive smoke. Salbutamol use was high (80.48%), and 32.86% used ICS. Symptoms ranged from mild (13.81%) to severe (23.81%). After six months, daytime cough reduced from 52.38% to 1.43%, and nighttime cough from 66.19% to 0%. Symptom-free days increased, and hospital admissions decreased from 90.95% to 9.05%. Common adverse events included worsening symptoms (13.81%) and fever (13.33%). Conclusions: Inhaled corticosteroid/betamethasone therapy significantly improved symptoms in infants and young children with RRIs over six months, reducing coughing, wheezing, shortness of breath, and hospital admissions, while increasing symptom-free days. Adverse events were mild and infrequent, suggesting ICS is effective and safe. Further research is needed to optimize treatment.

Increased Pneumonia Risk Associated with Concomitant Use of Inhaled Corticosteroids and Benzodiazepines: A Pharmacovigilance Analysis.

Inhaled corticosteroids (ICS) are effective in managing asthma and chronic obstructive pulmonary disease (COPD) but increase the risk of pneumonia. Benzodiazepines (BZD), commonly prescribed for comorbid psychiatric disorders in asthma or COPD patients, are also associated with pneumonia. This study investigates the risk of pneumonia associated with the concomitant use of ICS and BZD. Data from the FDA Adverse Event Reporting System from Q4 2013 to Q3 2023 were extracted. Reports involving asthma or COPD patients were included. Disproportionality analysis and logistic regression analysis were performed to assess the risk of pneumonia associated with the combined use of ICS and BZD. Additive and multiplicative models were used to further confirm the results. Additionally, subgroup analyses were conducted based on gender, age, and disease type. A total of 238,411 reports were included. The combined use of ICS and BZD was associated with a higher reporting of pneumonia (ROR: 2.41, 95% CI 2.25-2.58). Using additive and multiplicative methods, the results remained significant. The strongest risk signals were observed in specific drug combinations, such as mometasone with clonazepam, budesonide with temazepam, and mometasone with zopiclone. Subgroup analyses showed higher pneumonia risks in females, patients over 60years old, and those with asthma. Our findings identified a significantly elevated pneumonia risk with the combined use of ICS and BZD. These results highlighted the necessity for cautious co-prescription of ICS and BZD and suggested the need for more comprehensive clinical studies to assess this interaction.

DElaying disease Progression In COPD with early escalation to Triple therapy – A Modelling Study (DEPICT-2)

IntroductionIn patients with chronic obstructive pulmonary disease (COPD), dual bronchodilator (long-acting muscarinic antagonist (LAMA)/long-acting beta2-agonist (LABA)) and triple therapy (inhaled corticosteroid (ICS)/LAMA/LABA) reduce risk of exacerbations and lung function decline in short-mid-term, but their long-term impact is unknown. This modelling study explores long-term impact of these therapies on lung function decline, quality of life (QoL) and all-cause mortality.MethodsThis modelling approach used a longitudinal non-parametric superposition model using published data regarding exacerbations, QoL (assessed by St. George's Respiratory Questionnaire (SGRQ)), and mortality. The model simulated disease progression from 40 to 75 years of age and assessed the impact of initiating dual bronchodilator at age 45 years (“LAMA/LABA only” group) and escalation to triple therapy at age 50 years (“Escalation to triple” group) on forced expiratory volume in 1 s (FEV1) decline, QoL, and mortality.ResultsModel simulation predicted that by 75 years of age: “LAMA/LABA only” preserves 159.1 mL of FEV1versusno treatment, “Escalation to triple” preserves an additional 376.5 mL and 217.3 mL of FEV1versusno pharmacotherapy and “LAMA/LABA only”, respectively. In “LAMA/LABA only”, SGRQ score reduces (−3.2)versusno treatment, which further reduces to −7.5 therapy in “Escalation to triple”. In “LAMA/LABA only”, mortality reduces by 5.4% by 75 yearsversusno treatment, while the “Escalation to triple” shows further decrease in mortality by 12.0%.ConclusionEarly pharmacotherapy initiation and escalation from dual bronchodilator to triple therapy could slow disease progression by preserving lung function and improving QoL and survival in patients with COPD.

For people with uncontrolled asthma, how does adding long-acting beta2 agonists (LABA) or long-acting muscarinic antagonists (LAMA) to different doses of inhaled corticosteroids (ICS) or doubling the dose of ICS compare with medium-dose ICS?

For people with uncontrolled asthma, how does adding long-acting beta2 agonists (LABA) or long-acting muscarinic antagonists (LAMA) to different doses of inhaled corticosteroids (ICS) or doubling the dose of ICS compare with medium-dose ICS?

Treatment patterns in patients with newly diagnosed COPD in the USA

BackgroundPrompt and effective management with maintenance therapy (single or dual bronchodilator therapy) is recommended after the initial diagnosis of chronic obstructive pulmonary disease (COPD) to maintain lung function and prevent exacerbations. Contrary to guideline-based recommendations, most patients are not prescribed maintenance treatment at initial diagnosis. The current study assessed the pharmacologic treatment patterns and outcomes of newly diagnosed patients with COPD in the USA.MethodsThis retrospective, noninterventional study used de-identified data from the Inovalon Insights’ database (Commercial, Medicaid Managed Care, and Medicare Advantage–insured individuals) between January 1, 2015, and December 31, 2021. The “patient journey” from initial diagnosis was followed over a 4-year period. The primary outcome measure was the number of moderate or severe exacerbations. Secondary outcome measures included the cumulative incidence of exacerbations, mean cumulative count of moderate and severe exacerbations, rates of moderate and severe exacerbations in patients who remained untreated after diagnosis in 12-month time periods for 4 years, sociodemographic and clinical characteristics, and pharmacologic treatment patterns.ResultsThe cohort consisted of 238,158 newly diagnosed patients with COPD (female [52.9%]; mean age 63.8 years). The majority of patients with COPD had Medicaid as their primary insurance (46.2%). Overall, during the 4-year follow-up period, 32.9% of the patients had at least one moderate or severe exacerbation, and 25.8% and 13.8% experienced moderate and severe exacerbations, respectively. At diagnosis, 86.2% of the patients were untreated and most remained untreated by the end of the follow-up (63.8%). Most patients (62.0%) received long-acting beta-agonist (LABA)/inhaled corticosteroids (ICS) as their initial treatment at diagnosis, and LABA/ICS continued to be the most common initial treatment during the 4-year period (64.0% at year 1; 58.0% at year 4).ConclusionsMost patients with COPD were not treated at initial diagnosis and remained untreated during follow-up. Our data highlight a lack of adherence to recommendations for clinical practice.

The Impact of Eliminating Out-of-Pocket Payments on Asthma Medication Use.

High costs of controller therapies may be a barrier to guideline-recommended asthma treatment. We determined whether eliminating out-of-pocket (OOP) payments among low-income patients with asthma impacted controller medication use. We applied a controlled interrupted time series design to administrative claims data in British Columbia, Canada from 2017-2020. Cases were individuals with an annual household income <$13,750 in whom copays were eliminated on January 2019; there was no change in public coverage for the control group with annual income >$45,000. We evaluated trends in asthma medication costs, use, the ratio of inhaled corticosteroid (ICS)-containing medications to all asthma medications, excessive use of short-acting β-agonists (SABA) (>1 canister/month), and the proportion of days (PDC) covered by controller therapies. There were 12,940 cases (62% female, mean age 30.3 years, SD 14.9), and 71,331 controls (55% female, mean age of 31.3 years, SD 16.3). Removal of OOP payments increased monthly mean medication costs by $3.32 (95% CI $0.08 - $6.56, 2020 Canadian dollars), days supply of controller medications by 1.50 days (95% CI 0.61 - 2.40), and the ratio of ICS-containing medications to total medications by 4.20% (95% CI 0.73% - 7.66%) compared to the control group. The policy had no effect on PDC by controller therapies (0.01, 95% CI -0.01 - 0.04), but non-significantly decreased the percentage of patients with excessive SABA use (-6.37%; 95% CI -12.90% - 0.16%). Removal of OOP payments increased the dispensation of controller therapies, suggesting cost-related non-adherence could impair optimal asthma management.