北京若生智能科技有限公司
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beclometasone + formoterol (CHF 1535 NEXThaler / CHF 1535 NEXT DPI / Inuvair)

✓ Approved

Chiesi Farmaceutici S.p.A. · ADRB2 · 小分子

什么是 beclometasone + formoterol？

beclometasone + formoterol 是一种小分子，由Chiesi Farmaceutici S.p.A.研发。该药已获批，用于治疗相关适应症，给药途径：Inhaled。

药物档案

商品名CHF 1535 NEXThaler, CHF 1535 NEXT DPI, Inuvair
公司Chiesi Farmaceutici S.p.A.
药物类别小分子
分子靶点ADRB2, NR3C1
给药途径Inhaled
状态Approved
来源： ClinicalTrials.gov, Chiesi Farmaceutici S.p.A.

作用机制

分子靶点

beclometasone + formoterol 作用于 2 个分子靶点：

ADRB2adrenoceptor beta 2 (B2AR, ARB2)
NR3C1nuclear receptor subfamily 3 group C member 1 (GR, GCCR)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

beclometasone + formoterol 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Respiratory, thoracic and mediastinal disordersAsthma✓ Approved
Respiratory, thoracic and mediastinal disordersChronic obstructive pulmonary disease✓ Approved

相关研究文献

PubMedERJ open research2026-09-08

A study protocol for a randomised controlled trial of two stepwise pharmacological treatment approaches to adult asthma: inhaled corticosteroid/formoterol reliever- versus short-acting β2-agonist reliever-based therapy - Asthma on TRACK.

Sayers Ross R, Cullen Ryan R, Oldfield Karen K, Barrett Jonathan J et al.

No randomised controlled trials (RCTs) have compared inhaled corticosteroid (ICS)/formoterol reliever-based stepwise algorithms with short-acting β-agonist (SABA) reliever-based stepwise algorithms, titrated to levels of asthma control and exacerbations. Knowledge gaps remain in understanding ICS exposure over time, transitions between treatment steps, efficacy and participant satisfaction with different algorithm approaches. The aim of the study is to determine the exposure to ICS in adults and adolescents aged 16 to 75 years treated with a budesonide/formoterol reliever-based algorithm (Algorithm 1) compared to a salbutamol reliever-based algorithm (Algorithm 2) across the spectrum of asthma severity. This is an investigator-initiated, 52-week, single-site, open-label, parallel-groups, 2-arm RCT of 152 adults and adolescents with mild, moderate and moderate-severe asthma (ACTRN12624001488594). Participants will be randomly allocated in a 1:1 ratio to a budesonide/formoterol reliever-based or a salbutamol reliever-based algorithm. Global Initiative for Asthma (GINA) treatment step at enrolment according to the 2024 GINA Guidelines will be used to allocate participants to the corresponding steps of each algorithm. Treatment step transition will be in response to asthma exacerbations and level of asthma control. Those experiencing exacerbations or poorly controlled asthma will be stepped up, and those well controlled stepped down. The primary outcome is ICS exposure. Important secondary outcomes include composite systemic corticosteroid exposure, rates of asthma exacerbations, asthma control, T-helper 2 biomarkers, spirometry and participants' treatment perceptions and satisfaction. This is the first RCT to compare ICS/formoterol- and SABA-based reliever stepwise algorithmic approaches in asthma, with treatment adjusted according to asthma control and exacerbations.

PMID 42707905
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PubMedThe Journal of asthma : official journal of the Association for the Care of Asthma2026-09-07

Inhaled corticosteroids with short-acting β2-agonists as rescue therapy for asthma: a systematic review and meta-analysis of randomized controlled trials.

Butt Abaan A, Qureshi Sarah S, Tanveer Nida N, Hussain Nabah N et al.

The Global Initiative for Asthma (GINA) recommends inhaled corticosteroid (ICS)-containing regimens for all patients, advising against short-acting β2-agonist (SABA) monotherapy. While ICS-formoterol is the preferred reliever, the role of ICS-SABA remains less clearly defined. We searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and WHO ICTRP from inception to November 2025 without language restrictions. Eligible studies were randomized controlled trials (RCTs) comparing as-needed ICS-SABA with SABA-only reliever therapy in patients with asthma. Random-effects models were used to pool relative risks (RR), hazard ratios (HR), mean differences (MD), and standardized mean differences (SMD). Five RCTs were included in the meta-analysis. ICS-SABA significantly reduced exacerbation rates (RR = 0.69, 95% CI: 0.52-0.91), risk of at least one exacerbation (RR = 0.69, 95% CI: 0.51-0.93), and prolonged time to first exacerbation (HR = 0.74, 95% CI: 0.62-0.89). Only the rate interaction favored milder asthma (GINA steps 1-2; one trial); the time-to-first and risk interactions were nonsignificant. Symptom-control and quality-of-life estimates favored ICS-SABA but were nonsignificant; systemic corticosteroid exposure was markedly reduced (MD = -38.51 mg, 95% CI: -65.97 to -11.04). No increase in adverse or serious adverse events was observed. ICS-SABA reliever therapy provides consistent reductions in asthma exacerbations and systemic corticosteroid use without compromising safety, supporting its role as a pragmatic alternative to ICS-formoterol rescue therapy. Future research should include head-to-head comparisons with ICS-formoterol, pediatric-focused trials, and long-term real-world studies to optimize asthma care.

PMID 42704292
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PubMedJournal of asthma and allergy2026-08-29

Gene Polymorphisms Associated with Treatment Response of Asthma in Chinese Children.

Zhu Lili L, Jiang Xinyi X, Li Changchang C, Zhu Tingting T et al.

To investigate the potential associations between therapeutically relevant single nucleotide polymorphisms (SNPs) with clinical characteristics and medication response of asthma in Chinese children. This prospective observational study was conducted at the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University from August 2021 to July 2022. Patients diagnosed with asthma and age-matched healthy individuals were recruited. Genotyping of 55 SNPs was performed using the Sequenom Mass Array platform. Both the association of 55 SNPs with clinical characteristics of asthma and the efficacy of budesonide/formoterol were analyzed. A total of 412 asthma patients and 262 age-matched healthy were recruited. The Minor Allele Frequency of SNPs differs markedly from that observed in European, American, and African populations but closely in the Asian populations. Comparing genotype and allele frequencies revealed that ORMDL3-rs2872507 (AA) and ZNF432-rs3752120 (TT) were significantly more frequent in the asthma group than in the control group. ZNF432-rs3752120 and ORMDL3-rs2872507 were further analyzed, stratified by clinical features and laboratory indicators. Atopy was significantly more common in ZNF432-rs3752120 TT genotype carriers compared to CC and CT genotypes. Additionally, the demand for inhalation device use was higher in CT carriers compared to those with CC and TT genotypes. However, no significant differences in asthma clinical characteristics were observed among ORMDL3-rs2872507 genotypes. Besides, eight SNPs were confirmed to be associated with the response of inhaling Budesonide/Formoterol dry powder 80/4.5. This study revealed that the ORMDL3-rs2872507 AA genotype and the ZNF432-rs3752120 TT genotype might be susceptible genotypes in Chinese children with asthma. rs1042713, rs2305089, rs2540487, rs2712807, rs28364072, rs320995, rs4980524, and rs730012 were identified as potentially associated with the efficacy of Budesonide/Formoterol (80/4.5) inhalation therapy in a cohort of children with asthma from southern Zhejiang, China.

PMID 42666756
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PubMedThe Journal of asthma : official journal of the Association for the Care of Asthma2026-08-19

Real-world comparison of inhaled corticosteroid monotherapy versus fixed-dose inhaled corticosteroid/long-acting beta-2 agonist combinations in children aged 6-11 years with persistent asthma.

Kaya Muhammet M, Anıl Hülya H, Şapcı Niyazi Onur NO, Aslan Sinem S et al.

In children aged 6-11 years with persistent asthma, earlier use of inhaled corticosteroid (ICS)-long-acting beta-2 agonist combination therapies has become a topic of increasing interest in recent years; however, available evidence in this age group remains limited. This study aimed to compare ICS monotherapy, fixed-dose ICS/salmeterol, and fixed-dose ICS/formoterol therapies regarding asthma exacerbations requiring systemic corticosteroids. This retrospective study included children aged 6-11 years with persistent asthma who were followed for at least 1 year while receiving regular inhaled therapy between January 2021 and August 2024. Patients classified as The Global Initiative for Asthma (GINA) steps 2-4 were grouped according to treatment with ICS monotherapy, fixed-dose ICS/salmeterol, or fixed-dose ICS/formoterol. Asthma exacerbations were assessed based on the need for systemic corticosteroids, emergency department visits, and/or hospitalization. A total of 296 children aged 6-11 years with persistent asthma met the inclusion criteria: 184 received fluticasone propionate (FP), 47 received fluticasone propionate/salmeterol (FP/SAL), and 65 received budesonide/formoterol (BUD/FOR). The groups differed in age at initiation of inhaled therapy (p < 0.001) and duration of follow-up (p = 0.014). Overall, 113 patients (38.2%) experienced at least one asthma exacerbation during follow-up, with no significant difference among FP, FP/SAL, and BUD/FOR groups (p = 0.93). Rates of emergency department visits and hospital admissions were also comparable between groups (p = 0.805 and p = 0.383, respectively), and no significant differences were found regarding systemic corticosteroid-requiring asthma exacerbations. In children aged 6-11 years with persistent asthma, no single controller therapy demonstrated clear superiority in preventing asthma exacerbations.

PMID 42613771
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PubMedVascular pharmacology2026-08-16

Formoterol fumarate attenuates atherosclerosis and improves cardiometabolic dysfunction in ApoE-deficient mice.

Juvenal Havyarimana H, Gu Wenjiao W, Zhao Zhihui Z, Pan Yunqi Y et al.

Apolipoprotein E-deficient (ApoE KO) mice develop severe dyslipidemia, atherosclerosis, vascular dysfunction, and hepatic metabolic abnormalities, closely mimicking human cardiometabolic disease. Formoterol fumarate (FF), a long-acting β₂-adrenergic receptor agonist, has been implicated in metabolic regulation; however, its potential novel effects on atherosclerosis-associated multi-organ dysfunction have not been thoroughly characterized. Eight-week-old male ApoE KO mice received FF of two doses (0.1 and 0.3 mg/kg/day) or vehicle for 8 weeks. Body weight, serum lipid profiles, and liver and heart damage biomarkers were measured. En face Oil Red O staining and aortic root histopathology assessed atherosclerotic lesion load. Plaque macrophage infiltration was assessed by CD68 immunofluorescence. Isolated aortic ring testing measured vascular reactivity. Cine MRI studied cardiac structure and function. MRI-derived PDFF and R2* mapping were used to assess hepatic fat content and tissue characteristics, respectively. Levels of lipid and collagen in the liver were evaluated. FF treatment significantly reduced serum triglycerides, total cholesterol, and low-density lipoprotein cholesterol in a dose-dependent manner, accompanied by a marked reduction in atherosclerotic plaque burden and CD68-positive macrophage accumulation within plaques. FF dose-dependently improved vascular reactivity by enhancing endothelium-dependent relaxation without affecting endothelium-independent responses. Cardiac MRI demonstrated the FF improved left ventricular systolic function, characterized by reduced end-diastolic and end-systolic volumes and increased ejection fraction, stroke volume, and cardiac output, without changes in heart rate or left ventricular mass. In addition, FF alleviated hepatic lipid deposition and fibrosis, reduced serum aminotransferase levels, and significantly decreased hepatic lipid accumulation as demonstrated by reduced PDFF and R2* values on MRI. FF confers broad cardiometabolic protection in ApoE KO mice, characterized by lipid lowering, attenuation of atherosclerosis, improvement of vascular and cardiac function, and amelioration of hepatic metabolic abnormalities and fibrosis. These findings provide new evidence for FF as a potential therapeutic candidate for cardiometabolic disease associated with dyslipidemia.

PMID 42604723
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PubMedInternational journal of molecular sciences2026-08-13

Endothelial Responses to ICS/LABA Combinations Are Determined Primarily by the Corticosteroid Component.

Redwan Bassam B, Biancosino Christian C, Mehdizadeh-Shrifi Amir A, Lennartz Felix Nikolaus FN et al.

The pulmonary microvasculature plays an essential role in maintaining alveolar integrity, but the direct effects of inhaled corticosteroids (ICS) on pulmonary endothelial cell function remain poorly understood. We investigated the effects of budesonide, formoterol, and their combination on endothelial network formation, apoptosis, migration, proliferation, and efferocytosis using human pulmonary microvascular endothelial cells (HPMEC-ST1.6R), A549 alveolar epithelial cells, and phagocytic cell models. Budesonide, alone or combined with formoterol, altered endothelial network formation on Matrigel by reducing total tubule length and the number of junctions while increasing tubule thickness, indicating reduced branching complexity. Budesonide also decreased epithelial secretion of the pro-angiogenic mediators VEGF, IL-8, and MCP-1. An independent set of experiments showed that fluticasone propionate similarly reduced VEGF, IL-8, MCP-1, TNF-α, and IL-6, supporting a class effect of corticosteroids on the epithelial secretome. Despite reducing angiogenic responses, budesonide protected endothelial cells from apoptosis, reduced caspase-3/7 activity, accelerated wound closure without affecting proliferation, preserved endothelial spheroid integrity, and enhanced efferocytosis. Formoterol alone had minimal effects and did not consistently enhance budesonide responses. Together, these in vitro findings suggest that, in the cell models studied, pulmonary endothelial responses to the ICS/LABA combinations tested are determined predominantly by the corticosteroid component, which suppresses pro-angiogenic mediator secretion while preserving endothelial survival and repair. As an exploratory cell-based study, these observations are hypothesis-generating and require confirmation in primary cells and in vivo models before clinical inferences can be drawn.

PMID 42589695
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