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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

PubMedEuropean heart journal2026-09-10

Exercise stress echocardiography for diagnosis of heart failure with preserved ejection fraction: a multicentre study.

Harada Tomonari T, Reddy Yogesh N V YNV, Sorimachi Hidemi H, Naser Jwan A JA et al.

Exercise stress echocardiography is recommended as an alternative to invasive testing for diagnosing heart failure with preserved ejection fraction (HFpEF), but an evidence-based operational framework guiding its application is lacking. Patients with chronic unexplained dyspnoea underwent invasive haemodynamic exercise testing with simultaneous echocardiography to test the hypotheses that (i) the current diagnostic algorithms (H2FPEF, HFA-PEFF, and HFpEF-ABA scores) could be enhanced when combined with exercise echocardiography; and (ii) incorporating resting left atrial (LA) compliance (LA reservoir strain divided by E/e') could further improve diagnostic triage, using separate cut points optimizing sensitivity and specificity. Findings were then validated in an international multicentre cohort. Of 482 patients, HFpEF was present in 386 and non-cardiac dyspnoea in 96. Sensitivity to detect HFpEF was only 55%-60% and accuracy 61%-67% using individual diagnostic scores with currently recommended exercise echocardiography. Addition of abnormal resting LA compliance to exercise echocardiography increased sensitivity to 84%-85% but increased the false-positive rate to 31%-43%. Applying separate cut points that optimize specificity and sensitivity (either exercise E/e' ≥ 13.8 or resting LA compliance ≤1.6% to rule-in HFpEF; both exercise E/e' < 7.2 and resting LA compliance >4.4% to rule-out HFpEF, remaining patients indeterminate who require invasive testing) improved sensitivity to 95%-99% among definitively classified patients and reduced the number of patients that require invasive exercise testing from ∼60% to ∼30%. Findings were replicated in a multicentre, international validation cohort of patients undergoing rest-exercise echocardiography and invasive exercise testing. Currently used non-invasive approaches to HFpEF diagnosis have inadequate sensitivity, indicating that exercise echocardiography cannot supplant invasive testing. Addition of LA strain imaging with optimized rule-in or rule-out values improves diagnostic triage by expanding non-invasive rule-in/rule-out classifications while identifying patients who still require invasive testing in the evaluation of HFpEF.

PMID 42720269
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PubMedJournal of glaucoma2026-09-08

Contrast-to-noise Ratios to Evaluate the Added Value of the Ganglion Cell Complex Thickness for the Detection of Progression in Glaucoma.

Majoor Juleke E A JEA, Vermeer Koenraad A KA, Gardiner Stuart K SK, Yang Hongli H et al.

This study shows that GCC thickness is most sensitive for detecting progression at the onset of glaucoma, but less sensitive than cpRNFL thickness. These findings suggest no clear additional value of GCC thickness over cpRNFL overall, although further evaluation in larger cohorts with advanced glaucoma is warranted. To compare the sensitivity of ganglion cell complex (GCC) thickness in the macula to circumpapillary retinal nerve fiber layer (cpRNFL) thickness from OCT, and Mean Deviation (MD) and Visual Field Index (VFI) from Standard Automated Perimetry (SAP), for detecting glaucomatous progression across glaucoma stages. Using longitudinal data from 205 eyes (125 participants), contrast-to-noise ratios (CNRs) were calculated for GCC, cpRNFL, MD and VFI. Glaucoma stage was defined by MD. Contrast was the parameter difference between two stages; noise was the variability from linear regression residuals from five consecutive OCT scans and HFA 24-2 tests per eye. Higher CNR indicates greater sensitive for detecting progression between stages. CNRs ranged from 3.7 to 13.2. In the transition from suspect to mild glaucoma, cpRNFL (13.2) and GCC (8.7) had significantly higher CNRs than MD (4.5) and VFI CNR (4.8); cpRNFL was also significantly higher than GCC. No significant CNR differences were found between structural and functional measures in later stages. GCC thickness is more sensitive than functional measures, but less than cpRNFL thickness, for detecting progression at glaucoma onset. In later stages, structural and functional parameters showed comparable sensitivity within the limits of the available data.

PMID 42708835
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PubMedAmerican heart journal2026-09-06

Incidence, medical therapy, and outcomes in heart failure with improved ejection fraction across guideline definitions.

Agharahmanian Arash A, Min Kyung H KH, Go Alan S AS, Parikh Rishi V RV et al.

To assess the incidence of heart failure with improved ejection fraction (HFimpEF) across guideline definitions (ACC/AHA, ESC, HFA/HFSA/JHFS) and to evaluate differences in guideline directed medical therapy (GDMT) utilization and rates of heart failure hospitalization (HF) or death among patients meeting each criterion. We identified patients with incident heart failure with reduced ejection fraction (HFrEF) between January 2013 and December 2024 within the Kaiser Permanente Northern California (KPNC) healthcare system. HFimpEF was defined with a follow-up LVEF that satisfied at least one of three definitions: ACC/AHA (EF > 40%), HFA/HFSA/JHFS (EF > 40% with ≥10-point increase), and ESC (EF ≥ 50%). We assessed (1) HFimpEF incidence, (2) the one-year post-diagnosis mutually exclusive incidences of HF hospitalization or death, and (3) GDMT use across each definition. Of 37,443 patients with newly diagnosed HFrEF, 15,030 (40.1%) were classified as HFimpEF based on the ACC/AHA definition, 13,253 (35.4%) based on the HFA/HFSA/JHFS definition, and 10,304 (27.5%) based on the ESC definition. Mutually exclusive cumulative incidences of HF hospitalization or death at 10 years after HFimpEF were higher among patients whose EF improvement met the ACC/AHA definition but did not meet the other two (Figure 2, log-rank p<0.001). Based on definition used, the prevalence of HFimpEF ranges widely from 28-40%. Irrespective of definition, patients with HFimpEF remain at residual risk for clinical deterioration and share a similar prognosis despite improvement in EF. These data highlight the persistence of heart failure rather than true recovery; trials to optimize available and new HF treatments are warranted.

PMID 42702264
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PubMedPharmaceutical medicine2026-09-06

Managing Inhaler Environmental Sustainability and Effective Respiratory Care: Current Evidence, Challenges, and Opportunities.

Booth Amy A, Abbott Jasmin J, Workman Samantha S, Plumart Fionnuala F et al.

Growing global concern about climate change, alongside the widespread use of inhaler therapies, has intensified interest in the environmental sustainability of inhalers. The respiratory care community is increasingly focused on how to balance effective disease management with the need to avoid exacerbating environmental determinants of respiratory illness. Since Pharmaceutical Medicine last examined this topic in its article Sustainability in Inhaled Drug Delivery, the field has evolved rapidly, with notable developments. This Leading Article reviews the current evidence on the carbon footprints of inhalers and discusses strategies-along with their implications for patient care-aimed at reducing the environmental impact of inhaler therapies. We focus on strategies at the (a) health system level, including optimisation of respiratory care and inhaler choice, adherence, and technique, and (b) pharmaceutical industry level, including innovation and action related to next-generation lower-carbon propellants such as HFA-152a and inhaler circularity. While sustainability strategies exist, we acknowledge that progress is slow, and highlight key implementation, financial, and regulatory challenges that constrain their uptake. The article concludes by outlining recommendations to help support sustainable and effective respiratory care.

PMID 42701996
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PubMedJACC. Asia2026-09-03

Incremental Value of Left Atrial Strain in HFA-PEFF for Heart Failure With Preserved Ejection Fraction.

Kim Jihoon J, Cha Ji Hyun JH, Choi Ki Hong KH, Shin Heayoung H et al.

Because exercise testing is not feasible for a substantial subset of patients with suspected heart failure with preserved ejection fraction (HFpEF), the Heart Failure Association-Pre-test assessment, Echocardiography and natriuretic peptide score, Functional testing in cases of uncertainty, Final etiology (HFA-PEFF) score often leaves many patients in an indeterminate diagnostic category. The authors aimed to assess whether resting left atrial strain provides incremental diagnostic value beyond the HFA-PEFF score in patients undergoing exercise right heart catheterization. This prospective study enrolled 77 patients with confirmed HFpEF and 37 patients with noncardiac dyspnea (NCD). HFpEF was diagnosed by exercise right heart catheterization demonstrating elevated pulmonary capillary wedge pressure at rest or during exercise. Patients who did not meet HFpEF criteria were classified as NCD. The median HFA-PEFF score was 4 in patients with HFpEF and 2 in those with NCD (P = 0.007). Left atrial reservoir strain (LARS) was significantly lower in patients with HFpEF compared with those with NCD (26.4% vs 34.7%; P < 0.001). LARS was significantly correlated with exercise mean pulmonary capillary wedge pressure and peak oxygen consumption and declined progressively as more HFpEF criteria were met. The optimal cutoff of LARS for discriminating HFpEF from NCD was 32% (OR: 5.26; 95% CI: 2.30-12.58; P < 0.001). Adding LARS to the HFA-PEFF score improved the area under the curve from 0.65 (0.56-0.74) to 0.75 (0.65-0.85) (P = 0.019) when LARS was analyzed as a continuous variable and to 0.73 (0.63-0.83) (P = 0.026) when using the 32% cutoff. LARS provides additive diagnostic value beyond the HFA-PEFF score and may reduce the need for noninvasive and invasive stress testing in patients with suspected HFpEF.

PMID 42687453
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PubMedCureus2026-08-31

Impact of a Nutrient-Dense Oral Nutritional Supplement on Growth in At-Risk Filipino Children: A Single-Arm Study.

Frias Melchor Victor G MVG, Rogacion Jossie M JM, De Los Santos Garner A GA, Bautista Jimmy M JM et al.

Growth faltering and dietary inadequacy remain important concerns among Filipino preschool children at nutritional risk. This prospective, community-based, single-arm study evaluated anthropometric and dietary changes during a 120-day intervention of a nutrient-dense oral nutritional supplement (ONS) and dietary counseling. Children aged three to five years received two 250 mL servings daily (500 kcal/day) of a vanilla-flavored ONS for 120 days. Primary outcomes were changes in weight, height, weight-for-age (WFA), height-for-age (HFA), and weight-for-height (WFH) percentiles and z-scores; secondary outcomes included nutrient adequacy relative to the Philippine Dietary Reference Intake estimated average requirements (EARs), dietary diversity score (DDS), compliance, and health events. Of 268 screened children, 245 were enrolled; 223 completed follow-up and were included in the per-protocol (PP) analysis, and 239 were included in the intention-to-treat (ITT) sensitivity analysis. In the PP analysis, mean weight increased from 13.1 ± 1.4 kg to 14.2 ± 1.8 kg, and mean height increased from 95.5 ± 5.6 cm to 98.5 ± 5.4 cm (both p < 0.001). Median WFA z-score improved from -1.6 (IQR, -2.1 to -1.2) to -1.3 (IQR, -1.9 to -0.8), HFA z-score from -1.7 (IQR, -2.4 to -0.9) to -1.5 (IQR, -2.3 to -0.8), and WFH z-score from -0.8 (IQR, -1.1 to -0.7) to -0.7 (IQR, -1.1 to -0.3; all p < 0.001). Significant improvements in growth parameters were observed from day 30 and remained significant over the study follow-up. The proportion of children at or below the 25th percentile for WFH decreased from 100% at baseline to 46.2% by day 120. Energy inadequacy decreased from 76.0%-79.4% at baseline to 11.9%-15.6% at day 120, and protein inadequacy decreased from 24.0%-27.8% to 0%-0.8%. Compliance with video-observed treatment (VOT) ranged from 92.5% to 98.3%, and no ONS-related adverse events were recorded. In conclusion, nutrient-dense ONS combined with dietary counseling was associated with improved anthropometric status and nutrient adequacy over 120 days.

PMID 42670544
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