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HFA Modulite techn

✓ Approved

Chiesi Farmaceutici S.p.A. · 治疗药物

什么是 HFA Modulite techn？

HFA Modulite techn 是一种治疗药物，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

公司Chiesi Farmaceutici S.p.A.
给药途径Inhaled
状态Approved
来源： ClinicalTrials.gov, Chiesi Farmaceutici S.p.A.

治疗适应症

HFA Modulite techn 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Surgical and medical proceduresOral appliance application✓ Approved

相关研究文献

PubMedJapanese journal of ophthalmology2026-07-27

Comparison of AIZE-EX and SITA-standard visual field measurements in patients with glaucoma.

Kano Kiyoshi K, Nomoto Hiroki H, Matsumoto Chota C, Kusaka Shunji S et al.

To compare visual field test results between the AIZE-EX strategy of the imo perimeter and Humphrey field analyzer (HFA) Swedish interactive threshold algorithm (SITA)-standard in glaucoma patients. Prospective cross-sectional study METHODS: This study included 52 eyes of 26 patients with glaucoma. Binocular testing with imo 24plus (1-2) AIZE-EX (78 test points) and HFA 30-2 SITA-Standard (76 test points) results obtained within 3 months were compared. Mean deviation (MD) and patter standard deviation (PSD) were recalculated from the 24-2 test points (54 points) and compared between devices. Agreement was assessed using cluster-robust t-test, Bland-Altman analysis, and equivalence testing using two one-sided tests (TOST); margin ±1.5 dB). MD was -7.89 ± 6.86 dB for AIZE-EX and -8.24 ± 7.13 dB for SITA-Standard (bias: +0.35 dB; 95% LoA: -4.04 to +4.73 dB; p = 0.342). PSD was 8.52 ± 4.15 and 8.20 ± 4.72 dB, respectively (bias: +0.32 dB; 95% LoA: -2.94 to +3.58 dB; p = 0.190). TOST confirmed equivalence for both MD (90% CI: -0.26 to +0.95 dB; p = 0.002) and PSD (90% CI: -0.09 to +0.72 dB; p < 0.001). Proportional bias was absent for MD (p = 0.405) but present for PSD (p = 0.012). Test time for both eyes was significantly shorter with AIZE-EX (7 min 39 s vs. 15 min 24 s; p < 0.001). MD and PSD values were comparable between the AIZE-EX and SITA-Standard derived from 24-2 test points, demonstrating clinical equivalence. Test time was substantially shorter with the AIZE-EX despite a greater number of points, supporting its use in routine glaucoma follow-up.

PMID 42507298
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PubMedOrganic letters2026-07-23

MgO-Promoted [4 + 2] Cyclization Using HFA·3H2O/SOCl2/PPh3: Modular Synthesis of gem-Bis(trifluoromethyl)dihydrothiopyrans.

Zeng Zhengwu Z, Rao Junyi J, Pei Meng M, Xiang Lu L et al.

The present study reports an unprecedented [4 + 2] annulation for the modular synthesis of gem-bis(trifluoromethyl)-3,6-dihydro-2H-thiopyrans. The transformation employs readily available HFA·3H2O and SOCl2 as a convenient (CF3)2C═S surrogate in the presence of PPh3, with MgO promoting the subsequent thia-Diels-Alder reaction of 1,3-dienes. The method features a broad substrate scope, excellent practicality for gram-scale synthesis and late-stage functionalization of biologically active molecules, as well as versatile product derivatization. Mechanistic studies identify hexafluoroisopropyl polysulfide species as key intermediates in this process.

PMID 42490186
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PubMedEuropean heart journal. Digital health2026-07-23

Digital biomarkers in cardiovascular medicine: a scientific statement of the ESC Working Group on e-Cardiology, the ESC Working Group on Cardiovascular Pharmacotherapy, the European Heart Rhythm Association (EHRA) of the ESC, the Association for Acute Cardiovascular Care (ACVC) of the ESC, the Heart Failure Association (HFA) of the ESC, the European Association of Preventive Cardiology (EAPC) of the ESC, the European Association of Cardiovascular Imaging (EACVI) of the ESC, in collaboration with the Digital Cardiology and Artificial Intelligence Committee of the ESC, and the ESC Regulatory Affairs Committee.

Corredoira Pablo M PM, Kaski Juan Carlos JC, Duncker David D, Dörr Marcus M et al.

Cardiovascular disease is the leading cause of morbidity and mortality globally, imposing a substantial patient burden. Digital biomarkers derived from digital health technologies enable quantifiable, near-continuous, real-world capture of pathophysiological signals and are increasingly used across cardiovascular medicine. Their growth is often supported by big data analytics, artificial intelligence and connected sensors within the Internet of Things. This scientific statement systematically reviews digital biomarkers, their clinical utility across the cardiovascular care continuum, and summarizes major methodological and implementation challenges. We searched PubMed/MEDLINE, Embase and Scopus for phase III-IV cardiovascular trials published between 1 January 2019 and 1 August 2024 that collected digital biomarkers. We identified 541 records and included 32 trials (40 reports) enrolling 32 246 participants (44.71% women; mean age 66.2 ± 11.0 years). Heart failure was the most frequent target condition (16 trials, 50%), followed by cardiac implantable electronic devices trials (12 trials, 38%). Digital biomarkers included cardiac rhythm and heart rate, blood pressure, body weight, impedance-based measures, haemodynamic pressures, and physical activity and sleep patterns captured using diverse sensor technologies. Methodological quality was good (modal quality score 5; range 3-7), although most trials were unblinded. Current studies suggest potential clinical utility in selected cardiovascular conditions. Implementation remains challenging because of measurement variability, privacy and regulatory requirements, affordability and reimbursement barriers and inequities in access. Robust validation and outcome- and cost-effectiveness evidence are still needed. Registration number: CRD42024573879.

PMID 42491935
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PubMedRespiratory medicine2026-07-22

Developing low-carbon metered-dose inhalers: effects of propellant HFA-152a on mucociliary clearance and bronchoconstriction in two Phase 1 randomised trials.

Singh Dave D, Poggesi Italo I, Weng Stephen S, Slade David D et al.

To reduce the impact of respiratory care on climate change, metered-dose inhalers (MDIs) are being reformulated with low-global warming potential (GWP) propellants. Next-generation propellant hydrofluoroalkane (HFA)-152a has >90% lower GWP than HFA-134a. As part of the safety evaluation for HFA-152a, mucociliary clearance (MCC), bronchoconstriction and safety were compared with HFA-134a. Two Phase 1, randomised, two-way crossover studies (NCT06506266/NCT06702462) were conducted. MCC study: healthy participants inhaled HFA-152a and HFA-134a in two 7-day sequences. MCC was quantified as area under radiolabelled particle retention time curve over 4 hours (AUC0-4h) after nebulised 99mTc sulphur colloid, following each propellant. Bronchoconstriction study: patients with mild asthma inhaled single doses of HFA-152a and HFA-134a. Non-inferiority of HFA-152a versus HFA-134a was defined as percent change in FEV1 (litres), 15 minutes post dose (95% confidence intervals [CI]: lower limit >-10%, upper limit >0%). Both studies assessed safety. In 22 healthy participants, the impact on MCC did not differ between HFA-134a and HFA-152a (AUC0-4h geometric mean ratio [90% CI]: 1.00 [0.99,1.01]). In 19 patients with mild asthma, neither HFA-152a nor HFA-134a induced bronchoconstriction (percent change in FEV1 at 15 minutes: -0.37% [HFA-152a] vs -0.60% [HFA-134a]); HFA-152a was non-inferior to HFA-134a (mean difference [95% CI]: 0.23% [-3.61,4.07]). Adverse event (AE) rates were low and similar for both propellants in both studies; all AEs were mild, with no serious AEs or deaths. HFA-152a and HFA-134a had almost identical effects on MCC, neither induced bronchoconstriction, supporting MDI reformulation with the low-GWP propellant HFA-152a.

PMID 42480626
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PubMedInternational journal of hematology2026-07-22

Risk factors associated with high probability of pulmonary hypertension in patients with myeloproliferative neoplasms.

Leiva Orly O, Soo Steven S, Liu Olivia C OC, You Victor V et al.

Myeloproliferative neoplasms (MPNs) are associated with pulmonary hypertension (PH). Recent studies have demonstrated associations between PH and adverse cardiovascular outcomes and MPN disease progression. However, risk factors for development of PH and the pathophysiology of PH in MPNs remain unclear. We conducted an analysis of a multicenter retrospective cohort of patients with MPN with ≥ 2 transthoracic echocardiograms (TTEs) after MPN diagnosis. Patients with low probability of PH on the first TTE after MPN diagnosis were included. Backward stepwise Cox proportional hazards regression modeling was performed to identify risk factors for high probability of PH on subsequent TTE. Impact of incident high probability of PH on subsequent TTE, on major adverse cardiovascular event (MACE), hematologic progression, and death was examined using multivariable competing risk or Cox proportional hazards regression. After backward stepwise modeling, age at MPN, non-JAK2 driver mutations, polycythemia vera (PV) and myelofibrosis (versus essential thrombocythemia), leukocytosis, and elevated HFA-PEFF score were associated with increased risk of incident high probability of PH. Incident high probability of PH was associated with increased risk of MACE, hematologic progression, and death. Further studies are needed to evaluate the role of prospective screening for PH in patients with MPNs and further delineate pathophysiology of PH in patients with MPNs.

PMID 42481866
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PubMedEuropean journal of heart failure2026-07-22

Trends in Mortality, Heart Transplantation and Left Ventricular Assist Device use in Advanced Heart Failure between 2003 and 2022: data from the Swedish Heart Failure Registry.

Guidetti Federica F, Benson Lina L, Lindberg Felix F, Basile Christian C et al.

Advanced heart failure (AdvHF) remains a major clinical challenge, yet contemporary epidemiological real-world data on AdvHF patients are limited. Aim was to assess 20-year trends in clinical characteristics, outcomes, and use of left ventricular assist devices (LVAD) and heart transplantation (HTx) in patients with AdvHF and reduced ejection fraction (AdvHFrEF) in Sweden. Between 2003-2022, 5,323 patients (median age 76 [IQR 68-82], 23% females) included in the Swedish HF Registry met adapted ESC-HFA criteria for AdvHF (NYHA III-IV, EF<30%, ≥1 HF hospitalizations ≤6 months). Of these, 29% were eligible for AdvHF therapies (median age 63 [IQR 57-67] years, 18% females) according to the following additional criteria: ≤70 years old, no dialysis within ≤5 years, no active cancer within ≤3 years.Unadjusted temporal trends in 1-year outcomes (all-cause, CV and non-CV death, HTx and LVAD implantation) were presented as estimated annual percent change (eAPC). 1-year all-cause mortality declined significantly in the overall cohort (eAPC -3.8; 95%CI -5.3 to -2.2) as well as in patients eligible for AdvHF therapies (eAPC -3.2; 95%CI -6.3 to -0.1) over the study period. These improvements were largely driven by reductions in CV mortality (overall cohort: eAPC -4.3; 95%CI -6.0 to -2.6; eligible cohort: eAPC -5.6, 95%CI -9.4 to -1.7). Use of LVAD significantly increased over the study period, while HTx showed a modest but non-significant rise. In a large nationwide cohort, all-cause and CV-mortality among AdvHFrEF patients markedly declined over the past 20 years, potentially reflecting improvements in treatments. Despite progress, significant opportunities remain to improve access to and adoption of advanced therapies.

PMID 42485618
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