Background/Objectives: Quantitative computed tomography (CT) can be used to characterize airway responses to therapies for chronic obstructive pulmonary disease (COPD), but prospective real-world data in treatment-naïve patients remain limited, and the role of inflammatory markers as potential predictors of structural airway response is poorly understood. Methods: We conducted a prospective real-world study in treatment-naïve patients with moderate-to-severe COPD (n = 47). Lung function and chest CT were assessed at baseline and after 12 weeks of tiotropium/olodaterol (n = 34). Blood eosinophil count and high-sensitivity C-reactive protein (hs-CRP) were measured at baseline. Results: Lung function improved after 12 weeks (p < 0.05). Airway lumen area normalized to body surface area (Ai/BSA) increased from 10.2 ± 2.6 to 12.2 ± 2.7 mm[2]/m[2], whereas relative wall area (WA%) decreased from 58.3 (56.6-61.5) to 55.9 (54.4-57.9)% (both p < 0.001). Improvement in Ai/BSA did not differ between upper and lower lobes (p > 0.05). Higher baseline hs-CRP was associated with a smaller Ai/BSA increase (r = -0.454, p = 0.01). No statistically significant associations were detected between ΔAi/BSA and the evaluated baseline variables, including blood eosinophil count, Ai/BSA, age, smoking history and lung function measurements (all p > 0.05), or between blood eosinophil count and baseline Ai/BSA or WA% (both p > 0.05). Conclusions: Initial dual bronchodilator therapy improved lung function and CT-derived airway measurements. In this cohort, no statistically significant association was detected between blood eosinophil count and airway response, whereas higher hs-CRP was associated with a smaller Ai/BSA increase.

Current Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations emphasize symptom-driven management, which may limit the use of maintenance bronchodilator therapy in patients without dyspnea. In this exploratory post hoc analysis of the tiotropium in early-stage chronic obstructive pulmonary disease (Tie-COPD) trial, we assessed tiotropium in 305 patients with mild-to-moderate chronic obstructive pulmonary disease (COPD) and a modified Medical Research Council dyspnea score of 0 (157 tiotropium, 148 placebo). Over 2 years, tiotropium maintained a higher pre-bronchodilator forced expiratory volume in 1 s (FEV1) than placebo (adjusted between-group differences 143-183 mL; all p < 0.001). The lung function benefit was similar across subgroups defined by age, body mass index, symptom burden, blood eosinophil count, GOLD stage, and smoking (all p for interaction >0.05). The annual exacerbation rate was lower with tiotropium (adjusted incidence rate ratio 0.51, 95% confidence interval [CI] 0.32, 0.82; p = 0.005), as was the risk of a first clinically important deterioration (adjusted hazard ratio 0.55, 95% CI 0.43, 0.70; p < 0.001), whereas COPD assessment test and clinical COPD questionnaire scores did not differ. These hypothesis-generating findings indicate that tiotropium may provide benefits in lung function and exacerbations in COPD without dyspnea, suggesting that a strictly symptom-based treatment criterion warrants prospective reevaluation.

Preschool children with asthma are more susceptible to develop acute life-threatening respiratory distress leading to hospital admissions compared to school children and treatment options are limited for this age group. We evaluated the safety and efficacy of tiotropium as add-on therapy to inhaled corticosteroids (ICS) in preschool children with high-risk, partly controlled or uncontrolled asthma.

As a major public health issue, chronic obstructive pulmonary disease (COPD) causes approximately 2.7 million deaths worldwide each year and has a significant negative impact on patients' health. We have developed a novel long-acting fixed-dose combination dry powder inhalation formulation with synergistic therapeutic effects, containing indacaterol maleate (IND, a long-acting β2 agonist) and tiotropium bromide (TIO, a long-acting muscarinic receptor antagonist), aimed at improving the clinical management of COPD and providing patients with superior bronchodilator effects. We prepared composite powder formulations using different ratios of fine lactose powder and magnesium stearate, combined with active pharmaceutical ingredients of varying particle sizes. We conducted preliminary studies on the total mixture content, mixing uniformity, delivered dose (DD), and fine particle dose (FPD) of each formulation using high-performance liquid chromatography (HPLC). Further screening and characterization were performed using scanning electron microscopy (SEM), laser particle size analyzers, and powder X-ray diffraction (XRD); simultaneously, we conducted aerodynamic studies and accelerated stability testing on the selected optimal formulation. This formulation (F7) demonstrated superior performance compared to other formulations. It exhibited excellent mixing uniformity, appropriate content and optimal aerodynamic properties with FPD values near the median standard range. Accelerated stability testing confirmed excellent stability with no significant changes in crystalline form or aerodynamic properties after 6 months. The developed IND/TIO composite inhalation powder represents an innovative dual-bronchodilator DPI formulation. The dual-stage lactose carrier system significantly enhanced drug detachment efficiency and in vitro pulmonary deposition. The introduction of magnesium stearate effectively addressed challenges of poor flowability and particle aggregation in micronized APIs. The formulation exhibits simple preparation process, excellent stability, and superior in vitro pulmonary drug delivery efficacy, making it a promising therapeutic candidate for COPD treatment.

This study aimed to investigate the ameliorative effects of the traditional Chinese herbal compound formula, Shenge Yifei Formula, on pulmonary inflammation and function in mice with chronic obstructive pulmonary disease(COPD) and to elucidate its underlying mechanism from the perspective of inhibiting T helper 1(Th1) immune responses. A COPD model was established in C57BL/6 mice by intratracheal instillation of lipopolysaccharide(LPS) combined with passive smoking exposure. The mice were randomly divided into a blank group, a model group, a tiotropium bromide group, and low-and high-dose Shenge Yifei Formula groups. Following a 5-week intervention, pulmonary function tests and HE staining were performed to assess lung histopathological changes. Flow cytometry, multicolor immunofluorescence, and ELISA were employed to detect the proportion and distribution of CD4~+ C-X-C chemokine receptor 3(CXCR3)~+ Th1 cells in lung tissue, as well as the levels of interferon-γ(IFN-γ), interleukin-12(IL-12), and C-X-C motif chemokine ligand 10(CXCL10) in bronchoalveolar lavage fluid(BALF). Additionally, transcriptomic sequencing was conducted on lung tissue from the high-dose Shenge Yifei Formula group. The study demonstrated that, compared with the model group, Shenge Yifei Formula significantly improved pulmonary function in COPD mice and attenuated alveolar structural damage, airway remodeling, and inflammatory cell infiltration in a dose-dependent manner. Mechanistic investigations revealed that the high dose of Shenge Yifei Formula markedly reduced the proportion and density of CD4~+CXCR3~+Th1 cells in lung tissue and decreased the levels of IFN-γ, IL-12, and CXCL10 in BALF. Transcriptomic analysis further confirmed that its mechanism of action is closely associated with the modulation of immune pathways such as T cell differentiation and cytokine-cytokine receptor interaction. In conclusion, Shenge Yifei Formula effectively ameliorates pulmonary inflammation and dysfunction in COPD mice by inhibiting Th1 cell differentiation, recruitment, and the associated cytokine network. Unlike tiotropium bromide, which primarily improves ventilatory function, Shenge Yifei Formula exerts a significant inhibitory effect on the Th1 axis, suggesting a distinct advantage complementary to bronchodilator therapy at the level of immune inflammation. This study provides modern experimental evidence for the clinical application of Shenge Yifei Formula and indicates its therapeutic potential in COPD by concurrently targeting anti-inflammatory and anti-remodeling processes.

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease associated with inflammation and obstruction of the airways. COPD progresses through 4 stages of increasing airflow limitation — mild, moderate, severe, and very severe — with symptoms and functional limitations worsening at each stage. Symptoms include difficulty in breathing, cough, and flare-ups (exacerbations) that may require hospitalization. As of 2022–2023, the prevalence of COPD was 8.74% in Canada.

Lung hyperinflation in COPD adversely affects cardiac function and may influence autonomic nervous system activity. The onset of cardiac improvement with dual bronchodilator therapy remains uncertain.