A multicenter, randomized, double-blind, double-simulated, positive-controlled phase III clinical trial comparing the efficacy and safety of Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation (SalmexTM) with Seretide in adult subjects with bronchial asthma

开始日期2020-07-01

申办/合作机构

广州医科大学附属第一医院（广州呼吸中心）

NCT03543176

/ CompletedN/A

Claims-linked Survey Study to Assess Burden of Illness Among Patients Treated With LAMA/LABA vs ICS/LABA Single Inhaler Dual Therapy

The main purpose of the study is to assess the burden of illness for, COPD using both patient-reported symptom burden and claims-based economic burden, among the subjects treated with single-inhaler dual therapy treatments, Fluticasone/Salmeterol FLUT/SAL; Advair) or Umeclidinium/Vilanterol (UMEC/VI; Anoro) to support Global Initiative for Chronic Lung Disease (GOLD) category B recommendations. The study will use a health plan recruitment strategy and subject's will be recruited using Optum's health plan recruitment strategy to collect information relating to the subject's condition history, current treatment, smoking history, symptoms and symptom severity (Modified Medical Research Council Dyspnoea Scale [mMRC] and COPD Assessment Test [CAT]), and demographic and sociodemographic characteristics. A total of 2700 subject's, are planned to be enrolled in the study to reach the target evaluable sample size, n=770 subjects. Following completion of data collection, results of the survey, will be merged with claims data, covering the 12-month Baseline period for analysis. Pharmacy and medical claims data, will be used to calculate all-cause and COPD-related health care utilization and costs, treatment patterns, and Baseline clinical characteristics. The study duration is estimated to be of 12-months.

开始日期2018-05-31

申办/合作机构

GSK Plc

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100 项与 AL-209 相关的临床结果

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100 项与 AL-209 相关的转化医学

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100 项与 AL-209 相关的专利（医药）

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2,321

项与 AL-209 相关的文献（医药）

2025-09-01·COLLOIDS AND SURFACES B-BIOINTERFACES

A triple-cascade nanoreactor for potent anti-tumor chemodynamic and immunotherapy

Article

作者: Zhang, Yanyan ; Yin, Hang ; Zhu, Li-Min ; Li, Fan ; Wang, Tong ; Williams, Gareth R ; Wu, Junzi ; Liu, Yang ; Du, Yichao ; Xu, Jianxiang ; Zheng, Yilu

Chemodynamic therapy (CDT) has shown promising effects in the treatment of malignant tumors, especially in inducing immunogenic cell death (ICD). However, the therapeutic efficacy of CDT is much weakened due to limitations in tumor oxidative stress response, and intracellular H₂O₂ and catalyst levels. In order to solve these challenges, we have designed an intracellular acid-activated cascade nanoreactor (Sal/Fe₃O₄@SiO₂-NaCN) which induces ICD by accelerating the process of CDT-mediated ferroptosis. The nanoreactor operates in three synergistic steps. Firstly, the platform can catalyze the degradation of glucose to gluconic acid and H₂O₂ under ultrasound (US) exposure in an acidic environment. Secondly, Fe₃O₄ can then convert this H₂O₂ to ·OH. In addition, salinomycin (Sal) causes Fe accumulation in the cell and enhances the efficacy of the Fenton process. Extensive in vitro and in vivo experiments reveal the production of reactive oxygen species, accumulation of Fe in cells, and stimulation of ferroptosis and ICD. In a bilateral tumor model, magnetic resonance signals and excellent therapeutic effects were observed in vivo. This novel nanoreactor offers a promising strategy for CDT-based cancer treatment and immunotherapy.

2025-09-01·AQUATIC TOXICOLOGY

From pharmaceuticals to toxic threats: Unveiling the impact of furosemide and by-products on fish model

Article

作者: Duval, Aliénor ; Garrigue-Antar, Laure ; Sandré, Fidji

Pharmaceutical pollutants and their transformation products pose emerging challenges to aquatic ecosystems. Among these, furosemide (FUR), a widely used diuretic, has gained attention due to the potential ecological risks of its degradation products, saluamine (SAL) and pyridinium (PYR). This study investigates the sub-lethal effects of SAL and PYR on zebrafish larvae (Danio rerio), focusing on oxidative stress, cardiac function, and behavioral responses at environmentally relevant concentrations. Our results reveal that both SAL and PYR induce significant reactive oxygen species (ROS) production, leading to oxidative stress dysfunction. Cardiovascular analyses show marked alterations in heart rate, while behavioral assays demonstrate impaired locomotion, even at low exposure levels concentrations consistent with those detected in natural water bodies. Importantly, these effects were observed at concentrations where FUR itself showed no significant impact, emphasizing the greater toxicity potential of its degradation products. These findings underscore the need to incorporate pharmaceutical transformation products into environmental risk assessments and regulatory frameworks, as they may exert greater ecological threats than their parent compounds. Future studies are required to better elucidate the long-term and multi-trophic impacts of these pollutants on aquatic ecosystems.

2025-08-01·RESPIRATORY MEDICINE

Comparative effectiveness of inhaled fluticasone propionate/salmeterol and budesonide/formoterol fixed-dose combinations in asthma control – a retrospective United States database analysis

Article

作者: Gemicioglu, Bilun ; Fritscher, Leandro ; Hanania, Nicola A ; Boonsawat, Watchara ; Odo, Nnaemeka ; Mamjudar, Anurita ; Rendon, Adrian ; Stanford, Richard ; Hamouda, Mohamed

BACKGROUND:

Asthma affects over 260 million people globally, with significant health impacts. The Global Initiative for Asthma (GINA) 2024 report recommends inhaled corticosteroid/long-acting β₂-agonist (ICS/LABA) combinations, including fluticasone propionate/salmeterol (FP/SAL) and budesonide/formoterol (BUD/FOR), for maintenance treatment. Both combinations have demonstrated clinical benefits, with previous clinical trials and real-world studies showing comparable asthma control with FP/SAL and BUD/FOR. This United States (US)-based study compares the real-world effectiveness of FP/SAL and BUD/FOR on asthma control and treatment adherence.

METHODS:

This retrospective cohort study analyzed data from the US Optum's Market Clarity database (July 1, 2010, to December 31, 2019), with integrated medical, pharmacy claims, and clinical electronic health records. Patients aged ≥18 years with asthma at GINA Steps 3-4, and ≥1 pharmacy claim for FP/SAL or BUD/FOR (index) were included. Patients on other ICS/LABA therapy ≥12 months prior to index were excluded. Inverse probability of treatment weighting adjusted for confounders. Outcomes were stratified by asthma severity.

RESULTS:

A total of 57,000 patients were included (FP/SAL: 28,639; BUD/FOR: 28,361). Baseline characteristics were balanced post-weighting. Asthma control was similar between cohorts, with no significant differences in Asthma Control Test scores or short-acting β₂-agonist fills during the 12-month period following the index. Treatment adherence, assessed using proportion of days covered (≥0.8), was higher in the FP/SAL cohort (5.4 %) versus the BUD/FOR cohort (4.4 %; p < 0.001).

CONCLUSIONS:

FP/SAL and BUD/FOR were similarly effective for asthma control in real-world settings, while FP/SAL was generally associated with greater medication adherence, a key factor for long-term control.

100 项与 AL-209 相关的药物交易

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