Search Results (14)

Background: Treatment compliant with the Global Initiative for Asthma (GINA) can promote more effective disease control. Single-inhaler triple therapy (SITT) is one method that is used to optimize therapy in this context, but TRIPLE therapy is still employed by physicians to a limited extent. Objective: This study aimed to describe the factors influencing challenges in optimizing asthma therapy. Methods: A 19-question survey, created via the CATI system, was distributed among pulmonologists, allergologists, general practitioners, and internal medicine specialists in Poland, Greece, Sweden, Slovenia, and Austria. Results: Statistically significant percentage differences in the use of TRIPLE therapy in the context of asthma management were observed among countries as well as between pulmonologists, allergists, and other specialists. Overuse of oral corticosteroids (OCSs) to treat nonsevere and severe asthma in the absence of an approach that focuses on optimizing inhalation therapy among asthma patients receiving TRIPLE therapy was observed in different countries as well as among physicians with different specialties. Twenty elements associated with the challenges involved in diagnosing and managing difficult-to-treat and severe asthma were identified. Six clinical categories for the optimization of asthma therapy via SITT were highlighted. The degree of therapeutic underestimation observed among severe asthma patients was assessed by comparing actual treatment with the recommendations of the GINA 2023 guidelines. Conclusions: Physicians of various specialties in Europe are subject to therapeutic inertia in terms of their compliance with the GINA 2023 guidelines. Full article

Background/Objectives: Due to limited current evidence, this post-marketing database surveillance study aimed to investigate the occurrence of hospitalization due to community-acquired pneumonia (CAP) among patients with chronic obstructive pulmonary disease in Japan who received single-inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol; FF/UMEC/VI) or multiple-inhaler triple therapy (MITT). Methods: This retrospective cohort study used health insurance claims data from the Medical Data Vision Co., Ltd. database (November 2017–April 2023) to identify overall and incident users of FF/UMEC/VI or MITT. Index date was the start of FF/UMEC/VI or MITT. Hazard ratios (HRs) for CAP hospitalization were assessed using inverse probability of treatment weighting based on propensity scores (PS). Incidence rates and time to occurrence of CAP hospitalization were also assessed. Adjustments were made to the PS model to address missing body mass index data. Results: In total, 8790 and 10,881 patients were included in the overall FF/UMEC/VI and MITT cohorts, and 3939 and 4017 patients were included in the incident FF/UMEC/VI and MITT cohorts, respectively. HR for CAP hospitalization among incident users ranged from 1.05 to 1.15 across all PS adjustments. Similar incidence rates of CAP hospitalization were reported among both cohorts and across all PS adjustments. The cumulative adjusted incidence rates of first CAP hospitalization at 360 days post-index among incident users was 0.060 and 0.054 in the FF/UMEC/VI and MITT cohorts, respectively. Conclusions: There was no difference in the risk of CAP between patients treated with FF/UMEC/VI and MITT. This safety information may help healthcare providers select appropriate treatments. Full article

Background/objectives: This study aimed to investigate the impact of single-inhaler triple therapy on selecting treatment for lung cancer and the perioperative period in lung cancer patients with chronic obstructive pulmonary disease (COPD) and a forced expiratory volume in 1 s (FEV₁) <1.5 L. Methods: All patients had baseline FEV₁ < 1.5 L. The therapeutic drug for COPD, fluticasone furoate/umeclidinium/vilanterol, was initiated 2 weeks preoperatively and continued until 3 months postoperatively. Radical surgery was actively recommended for patients with an FEV₁ ≥ 1.5 L after COPD treatment; otherwise, palliative surgery and postoperative complication risks were discussed. Results: Among 675 lung cancer patients, 214 (31.7%) had COPD, 41 of whom with FEV₁ < 1.5 L were enrolled. After triple-inhaler therapy, FEV₁ improved to ≥1.5 L in 63.4% of patients. Significant differences in the Brinkman index (840 vs. 1120, p = 0.0058) and radical resection (88.5% vs. 40.0%, p = 0.0030) were observed between patients with FEV₁ ≥ 1.5 L and <1.5 L post-treatment. Pneumonia and home oxygen therapy occurred in two cases (4.9%) and one case (2.4%), respectively, all of which were patients with FEV₁ < 1.5 L post-treatment. Among patients undergoing anatomical lung resection, triple-inhaler therapy significantly improved not only post-inhalation FEV₁ (1.26 vs. 1.55 L, p < 0.0001), but also FEV₁ at 3 months postoperatively compared to the value before inhalation (1.31 vs. 1.26 L, p = 0.042). Conclusions: Preoperative triple therapy in lung cancer patients with untreated COPD and FEV₁ < 1.5 L improved respiratory function and increased the feasibility of performing radical resection surgery. Furthermore, it was considered safe and effective, indicating the potential to maintain preoperative respiratory function without increasing perioperative complications. Full article

Background: Japanese guidelines recommend the addition of a long-acting muscarinic antagonist for patients with asthma uncontrolled on inhaled corticosteroid/long-acting β₂-agonist (ICS/LABA) therapy, the effectiveness of which is evaluated here. Methods: Retrospective, observational, single-arm cohort study in patients with asthma initiating fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) following ICS/LABA, using independently analyzed data from Japanese claims databases: JMDC and Medical Data Vision (MDV). The index date was that of the first FF/UMEC/VI prescription. Outcomes were assessed during a 12-month follow-up versus a 12-month pre-index period (baseline) and included asthma exacerbations, oral corticosteroid (OCS) use, and short-acting β₂-agonist (SABA) use. P-values associated with rate ratios (RRs) were estimated using Conditional Poisson regression. Results: Overall, 3229 patients in the JMDC database and 1135 in the MDV database were included. Following FF/UMEC/VI initiation, the total annualized moderate–severe asthma exacerbation rate in the JMDC database reduced from 0.50 to 0.40 per-person-per-year (PPPY) (RR [95% confidence interval]: 0.78 [0.73, 0.84]; p < 0.001), with similar reductions in the MDV database: 0.53 to 0.42 PPPY (0.79 [0.70, 0.89]; p < 0.001). In both databases, there was a 20% reduction (JMDC: 0.80 [0.73, 0.88]; p < 0.001; MDV: 0.80 [0.68, 0.94]; p = 0.005) in patients with ≥1 OCS prescription after FF/UMEC/VI initiation. The proportion of patients with ≥1 SABA canister prescription dropped by 31% 0.69 [0.57, 0.84]; p < 0.001) in the JMDC database and 23% (0.77 [0.66, 0.90]; p < 0.001) in the MDV database. Conclusions: This suggests FF/UMEC/VI is effective in improving asthma exacerbations and reducing OCS and SABA use in Japanese patients previously using ICS/LABA in real-world clinical practice. Full article

Background: Despite the ongoing innovations and the availability of numerous effective inhaled treatment options, achieving optimal disease control in most patients frequently remains disappointing. Unfortunately, although inhaled therapy is the cornerstone of respiratory disease management, the selection of the most appropriate inhaler is still overlooked or underestimated by some healthcare professionals, and inhaler misuse remains a significant challenge in managing chronic respiratory diseases which directly influences patients’ quality of life, clinical outcomes, and risk of disease progression. Materials and Methods: This is a unicentric, observational, cross-sectional study designed to evaluate the inhaled therapy prescribed in hospitalized patients and to analyze device changes after hospitalization, as well as the factors associated with these changes. A single face-to-face visit was performed during the patient’s hospitalization, where the inhaled therapy used prior to hospitalization was evaluated: technique (critical errors), compliance (TAI questionnaire), maximum peak inspiratory flow [PIF (L/min)], and level of inhaler handling-related knowledge. A binary logistic regression model was used to explore the association between changing device at discharge and the other independent variables Results: The inhaler most used during hospitalization was the metered-dose inhaler (MDI) with a chamber (51.9% of patients), with the dry powdered inhalers (DPI) being the inhalers used in 43% of maintenance inhaled therapies in the community setting prior to hospitalization. In addition, 90% of patients showed a maximum PIF ≥ 30 L/min, and 35.6% performed critical inhaler errors. These patients had statistically significantly lower maximum PIF values (52.1 L/min in patients with critical inhaler errors vs. 60.8 L/min without critical inhaler errors; p > 0.001) and were more likely to exhibit poor inhaler compliance compared to those without critical errors (50.5% vs. 31.0%, respectively). More than half of the patients who used MDI with spacer chamber made critical inhaler errors; 69.9% showed regular or poor treatment adherence, although 75.6% demonstrated good knowledge about inhaler handling. Only in 27% of the patients did the healthcare professional change the type of inhaler after hospitalization within clinical practice. The medical and nursing staff responsible for the patient’s hospitalization were not informed of the assessment carried out in the study. The probability of not performing a device change at discharge was lower in patients with previous at-home treatment with combined inhaled therapy with LABA + ICS (OR 0.3 [0.18–0.83], p = 0.016) and in patients under triple inhaled therapy (OR 0.3 [0.17–0.76], p = 0.007). No significant differences were observed in inhaler changes when considering the frequency of critical inhaler errors, inhaler handling-related knowledge or maximum PIF values. Conclusions: Our study highlights the urgent need for a more personalized inhaler selection and consistent monitoring by healthcare professionals to minimize inhaler misuse, increase treatment compliance and adherence, and improve disease management outcomes. It is essential to provide training and promote the role of nursing in the evaluation and education of inhaled therapy. Additionally, the use of standardized approaches and tools, such as the CHECK DIAL, is crucial to facilitate the adaptation of devices to patients’ needs. Full article

Background/Objectives: Inhaler devices have been developed for the effective delivery of inhaled medications used in the treatment of pulmonary diseases. However, differing operating procedures across the devices can lead to user errors and reduce treatment efficacy, especially when patients use multiple devices simultaneously. To address this, we developed a novel dry powder inhaler (DPI), combining fluticasone propionate (FP), salmeterol xinafoate (SX), and tiotropium bromide (TB) into a single device designed for bioequivalent delivery compared to existing commercial products in an animal model. Methods: The micronized FP/SX/TB-loaded capsule was prepared by sieving, blending, and filling capsules. Capsule suitability of the drugs was investigated from the comparison of the stability of drugs within various capsule formulations to that of commercial products. The particle size of the drugs was adjusted using spiral air jet milling, and the ratio of lactose hydrate carriers was optimized by comparing the aerodynamic particle size distribution (APSD) with that of commercial products. To investigate the bioequivalence of micronized FP/SX/TB-loaded DPI to commercial products, the dissolution profile of FP/SX/TB particles and pharmacokinetics in rats were evaluated and compared to commercial products. Results: Capsules with hydroxypropyl methylcellulose (HPMC) without a gelling agent showed superior stability of the drugs compared to commercial products. The deposition pattern was influenced by the particle size of the drugs, and fine particle mass exhibited a significant correlation with the amount of fine carrier. Micronized FP/SX/TB-loaded DPI gave a similar APSD and dissolution profile compared to the commercial products and showed dose uniformity by the DPI device. Furthermore, micronized FP/SX/TB-loaded DPI exhibited bioequivalence to commercial products, as evidenced by no significant differences in pharmacokinetic parameters following intratracheal administration in rats. Conclusions: A novel triple-combination DPI containing FP/SX/TB was successfully developed, demonstrating comparable pharmacological performance to commercial products. Optimized FP/SX/TB-loaded DPI with HPMC capsule achieved bioequivalence in rat studies, suggesting its potential for improved patient compliance and therapeutic outcomes. This novel single-device DPI offers a promising alternative for triple therapy in pulmonary diseases. Full article

Background: Chronic obstructive pulmonary disease (COPD) is among the most relevant comorbidity associated with lung cancer. The advent of innovative triple treatment approaches for COPD has significantly improved patients’ quality of life and outcomes. Few data are available regarding the impact of triple inhaler therapy on patients featuring COPD and lung cancer. Methods: We retrospectively evaluated the impact of triple inhale bronchodilators in a cohort of 56 patients with treated COPD who underwent lung surgery for primary cancer. Results: Triple bronchodilation can help to relieve the symptoms of the disease and improve lung function, allowing people with lung cancer to reduce the risk of serious exacerbations and improve their quality of life. Conclusions: Within the limits of the study, it should be underlined that bronchodilators can effectively affect the outcome and performance status after thoracic surgery. Full article

Medication non-adherence remains a substantial obstacle in asthma care, prompting the exploration of novel therapeutic modalities that prioritize rapid symptom relief, anti-inflammatory activity, and facilitate patients’ compliance. This task is well-served by the following new form of therapy: inhaled triple-combination medications ICS/LABA/LAMA (inhaled glucocorticosteroid/long-acting beta2-agonist/long-acting muscarinic antagonist). The integration of three medications within a singular inhalation device culminates in the reduction of the effective dose of the principal therapeutic agent for asthma management, namely ICS. This consolidation yields a dual benefit of minimizing the likelihood of adverse effects typically linked with ICS while concurrently optimizing bronchodilator efficacy. The accumulated evidence suggests that adding LAMA to a medium- or high-dose ICS/LABA results in a decrease of asthma exacerbations compared to medium- or high-dose ICS/LABA alone, accompanied by sustained enhancements in lung function parameters. In adult patients experiencing suboptimal asthma control despite medium/high-dose ICS/LABA treatment—regardless of adherence to GINA-recommended strategies, such as MART therapy as a first-line approach, or alternative second-line strategies—we propose that the preferred course for intensifying asthma therapy involves the addition of a LAMA, ideally in the form of SITT. Full article

Background: Today, single-inhaler ICS/LAMA/LABA (SITT) COPD therapies are available. It is unclear whether they are more effective than multiple-device triple therapies (MITT) in improving COPD outcomes. Methods: We retrospectively considered patients on SITT/MITT in 2019/2020 who were prescribed >7 packages of ICS/LABA/LAMA or ICS/LAMA (+LAMA). The two treatments were compared concerning systemic corticosteroids, antibiotics, salbutamol, antifungal prescriptions, and number of emergency room visits/hospitalizations (ERV/Hs). We studied 292 MITT patients (Group A) during 2019, switching to SITT in 2020, and 366 subjects (Group B) who took SITT during 2019, and 206 MITT individuals (Group C) in 2020. Results: ICS/LABA + LAMA (MITT) package use was 8.2 ± 4.2 and 7.85 ± 4 in 2019, switching to 11.2 ± 3.2 when patients shifted to SITT in 2020 (p = 0.0001). Group A MITT package use was lower than in SITT patients in 2019 (9.31 ± 2.71, p = 0.0001; Group B). Throughout 2020, Group C (10.3 ± 6.1 packs) adherence to ICS/LABA was similar to SITT adherence in Group A (p = 0.270), whereas LAMA package use (9.1 ± 5) was lower (p = 0.0038). Patients using systemic corticosteroids/antibiotics were fewer in SITT in 2020, compared to the MITT results in 2019. Subjects with fewer ERV/Hs were observed with SITT rather than with MITT. Particularly, 13.8% of patients needed ≥2 ERV/Hs when treated with SITT, whereas 19.2% needed ≥2 ERV/Hs with MITT in 2019 (p = 0.08). Multivariate analysis, adjusted for all confounding factors including treatment adherence, showed that MITT (vs. SITT) can have an increased risk of at least one ERV/H (subjects receiving MITT during 2019 passing to SITT in 2020, OR: 1.718 [1.010–2.924], p = 0.046; Group A/MITT/2019 vs. Group B/SITT/2019, OR: 1.650 [0.973–3.153], p = 0.056; Group C/MITT/2020 vs. Group B/SITT/2019, OR: 1.908 [1.018–3.577], p = 0.044). Conclusions: SITT therapy may promote treatment adherence more effectively, therefore, reducing COPD exacerbations better than MITT. A possible synergistic effect of ICS/LABA/LAMA intake with a single device might be another cause of SITT’s greater efficacy. Full article

Background/Objectives: Several studies have demonstrated the positive clinical and functional impact of adding Long-Acting Muscarinic Antagonist (LAMA) to Inhaled Corticosteroids (ICS) and Long-Acting Beta-Agonists (LABA) therapy in the treatment of severe asthma. Aim and objectives: To demonstrate that treating Small Airways Disease (SAD) in severe asthma patients who are candidates for biologics can improve respiratory symptoms, lung function, and airways inflammation, potentially avoiding or delaying the use of biological therapy. Methods: Thirty-two severe asthma patients with SAD were transitioned from separate inhalers for ICS/LABA and LAMA to extrafine single-inhaler beclomethasone, formoterol, and glycopyrronium. None of these patients underwent biological therapy before the study. Follow-up evaluations were conducted at baseline (T0) and three months after initiation (T3). Assessments included clinical evaluations, spirometry, oscillometry, and inflammation markers. Results: Transitioning to single-inhaler triple therapy from T0 to T3 resulted in significant improvements in Asthma Control Test (ACT) and SAD parameters, including increased Forced Expiratory Volume in the mid-range of lung capacity and improved airway resistance and reactance measurements using impulse oscillometry. A significant reduction in airway inflammation was evidenced by lower levels of Fractional Exhaled Nitric Oxide 350 (FeNO 350) (p < 0.001 for all). Conclusions: Adopting a single-inhaler triple therapy notably enhanced clinical control and small airway function in patients with severe asthma and SAD, supporting the positive impact of target-therapy for the achievement of a stable state termed “Quiet Asthma”. Full article

Chronic obstructive pulmonary disease (COPD) is one of the major causes of disability and death. Maintenance use of inhaled bronchodilator(s) is the cornerstone of COPD pharmacological therapy, but inhaled corticosteroids (ICSs) are also commonly used. This narrative paper reviews the role of ICSs as maintenance treatment in combination with bronchodilators, usually in a single inhaler, in stable COPD subjects. The guidelines strongly recommend the addition of an ICS in COPD subjects with a history of concomitant asthma or as a step-up on the top of dual bronchodilators in the presence of hospitalization for exacerbation or at least two moderate exacerbations per year plus high blood eosinophil counts (≥300/mcl). This indication would only involve some COPD subjects. In contrast, in real life, triple inhaled therapy is largely used in COPD, independently of symptoms and in the presence of exacerbations. We will discuss the results of recent randomized controlled trials that found reduced all-cause mortality with triple inhaled therapy compared with dual inhaled long-acting bronchodilator therapy. ICS use is frequently associated with common local adverse events, such as dysphonia, oral candidiasis, and increased risk of pneumonia. Other side effects, such as systemic toxicity and unfavorable changes in the lung microbiome, are suspected mainly at higher doses of ICS in elderly COPD subjects with comorbidities, even if not fully demonstrated. We conclude that, contrary to real life, the use of ICS should be carefully evaluated in stable COPD patients. Full article

Long-acting muscarinic antagonists (LAMAs) are a class of inhalers that has recently been included as add-on therapy in the GINA guidelines, either in a single inhaler device with inhaled corticosteroids plus long-acting β2-agonists (ICS + LABA) (closed triple inhaler therapy) or in a separate one (open triple inhaler therapy). This review summarizes the existing evidence on the addition of LAMAs in patients with persistently uncontrolled asthma despite ICS + LABA treatment based on clinical efficacy in the reduction of asthma symptoms and exacerbations, the improvement in lung function, and its safety profile. Full article

Introduction: Chronic obstructive pulmonary disease (COPD) is the third cause of mortality and it is smoking-related. It is characterized by a non-reversible airflow limitation and a progressive worsening of the respiratory function. Objective: The aim of this study is to point out the benefit of smoking cessation combined with a single inhaler triple therapy in terms of clinical and functional outcome in this setting. Methods: A retrospective analysis was performed in patients affected by severe COPD and at least one exacerbation a year, who underwent a smoking cessation program. All patients underwent a 6 min walking test, body plethysmography, and an exhaled test for carbon monoxide. The modified medical research council test (mMRC) test, the Fagestrom nicotine dependency test (FTND) and the COPD assessment test (CAT) questionnaire were also administered. All patients were checked at the baseline and in the six-month follow-up after the start of the treatment. Results: Smoking cessation was achieved by 51% of patients within a month and it was confirmed by eCO measure (<7 ppm). Patients who quit smoking reported better results after six months compared with patients who did not. The increase in FEV1 within the group of quitters was 90 mL (p < 0.05) and the walking test improved by 90 m (p < 0.01); eCO decreased by 15 ppm (p < 0.01) while FVC increased by 70 mL (p < 0.05). No significant changes were recorded within the group of sustainers. The difference in functional changes between groups was significant with regard to FEV1, cCO, and WT. Conclusions: Smoking cessation enhances the efficacy of single inhaler triple therapy, improving clinical and functional variables after six months from the start. Full article

There are more single inhaler device triple therapy available for COPD patients now. However, the effect of long-term triple therapy fixed dose combination (FDC) on mortality remains unclear. This study aimed to evaluate the impact of one-year single inhaler device triple therapy, including long-acting β2-agonists (LABAs), long-acting muscarinic receptor antagonists (LAMAs), and inhaled corticosteroids (ICSs), with dual therapies, comprised of either LABA/LAMA or ICS/LABA, on the mortality of patients with COPD. We searched the PubMed, Cochrane library, Web of Science, Embase databases, and clinical trial registry of clinicaltrials.gov and WHO ICTRP. Randomized controlled trials (RCTs) compared single inhaler device triple and dual therapies for 52 weeks were selected for the meta-analysis. The primary endpoint was all-cause mortality. A total of 6 RCTs were selected for the meta-analysis, including 10,274 patients who received single inhaler device triple therapy (ICS/LABA/LAMA FDC) and 12,395 patients who received ICS/LABA or LABA/LAMA dual therapy. Risk of death was significantly lower in the ICS/LABA/LAMA FDC group compared to the LABA/LAMA group (RR = 0.69, 95% CI = 0.53–0.90, p = 0.007). There was no significant difference in mortality between the ICS/LABA/LAMA FDC and ICS/LABA therapy groups (RR = 0.94, 95% CI = 0.72–1.24, p = 0.66). In addition, patients receiving ICS/LABA/LAMA FDC therapy had less moderate or severe exacerbations compared with the dual therapy groups (RR = 0.76, 95% CI = 0.73–0.80, p < 0.001 for LABA/LAMA; RR = 0.84, 95% CI = 0.78–0.90, p < 0.001 for ICS/LABA). By contrast, the risk of pneumonia in the ICS/LABA/LAMA FDC group was higher than in the LABA/LAMA group (RR = 1.43, 95% CI = 1.21–1.68, p < 0.001). In conclusion, ICS/LABA/LAMA FDC therapy could help improve the clinical outcomes of patients with COPD. However, triple therapy could increase the risk of pneumonia in comparison with LABA/LAMA dual therapy. Full article