卡法克坦(Calfactant) - 在研适应症：新生儿呼吸窘迫综合征，呼吸窘迫综合征_专利_临床

概要

基本信息

药物类型

生物药

别名

Bovactant、Calf lung surfactant extract (CLSE)、Calfactant (USAN)

+ [1]

靶点-

作用机制

细胞膜通透性增强剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段批准上市

首次获批日期

美国 (1998-07-01),

呼吸窘迫综合征

最高研发阶段(中国)-

特殊审评孤儿药 (美国)

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关联

7

项与卡法克坦相关的临床试验

NCT03748173 / Terminated临床1期

Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 A Pilot Study of Aerosol Surfactant for Bronchiolitis in Infants

Delivery of aerosolized Infasurf to bronchiolitis patients with who are not on assisted ventilation can provide sufficient delivery of Infasurf to small airways to improve ventilation and thereby shorten the duration of the respiratory illness.

开始日期2019-01-12

申办/合作机构

ONY, Inc.

NCT03058666 / Completed临床3期

Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients

Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

开始日期2017-03-29

申办/合作机构

ONY, Inc.

NCT02834624 / CompletedN/AIIT

Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome

Premature infants frequently have trouble breathing after birth. If the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the infant through a tube inserted into the windpipe. This study will compare the safety of two of the commonly used surfactants, poractant and calfactant,in the United States. Poractant has added chemicals called phospholipids which are known to cause inflammation and irritation in the body of premature infants. The investigators will compare this to another similar surfactant that does not contain these chemicals by looking at samples from the windpipe, while the tube is in place, and from blood tests in the first few days of life.
The investigators are hoping to learn whether calfactant is a safer therapeutic agent to treat respiratory distress syndrome in preterm infants compared to poractant.

开始日期2013-07-01

申办/合作机构

University of Missouri

100 项与卡法克坦相关的临床结果

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100 项与卡法克坦相关的转化医学

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100 项与卡法克坦相关的专利（医药）

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138

项与卡法克坦相关的文献（医药）

2023-09-01·Archives of Medical Science

Comparative efficacy of pulmonary surfactant in respiratory distress syndrome in preterm infants: a Bayesian network meta-analysis

Review

作者: Fan, Nana ; Ma, Cui ; Zhang, Xiaoyu ; Zheng, Guofeng ; Qiu, Caihong

IntroductionThe comparative efficacy of pulmonary surfactant in the treatment of respiratory distress syndrome in preterm infants remains unclear. We aimed to evaluate the effectiveness of different pulmonary surfactant in the treatment of respiratory distress syndrome in preterm infants and to provide an evidence-based reference for clinical use.Material and methodsMEDLINE, Embase, The Cochrane Library, and Clinical Trials databases were electronically searched from inception to January 2019. Two reviewers independently screened literature and extracted data, and then R and RevMan 5.3 software packages were used to perform network meta-analysis.ResultsThe relative risk of respiratory distress syndrome in preterm infants associated with six different pulmonary surfactant was analysed, including beractant (Survanta), surfactant A (Alveofact), calfactant (Infasurf), poractant (Curosurf), lucinactant (Surfaxin), and colfosceril (Exosurf). Patients with the following drugs appeared to have significantly reduced mortality of respiratory distress syndrome compare with beractant: surfactant A (OR = 0.53, 95% CI: 0.31–0.90), calfactant (OR = 0.91, 95% CI: 0.85–0.97), poractant (OR = 0.72, 95% CI: 0.67–0.77), lucinactant (OR = 0.80, 95% CI: 0.71–0.90), and colfosceril (OR = 0.93, 95% CI: 0.87–0.99). The SUCRA (surface under the cumulative ranking) values for each of the drugs were: beractant (8.9%), surfactant A (93.8%), calfactant (40.3%), poractant (65.4%), lucinactant (59.8%), and colfosceril (31.6%).ConclusionsCompared with beractant, other pulmonary surfactants are more effective to reduce the mortality of respiratory distress syndrome in preterm infants. Surfactant A drugs appeared to have the best efficacy in reducing mortality of respiratory distress syndrome in preterm infants.

2023-08-31·mBio

A new tractable method for generating human alveolar macrophage-like cells in vitro to study lung inflammatory processes and diseases.

Article

作者: Jarvis, Natalie ; Arnett, Eusondia ; Lai, Zhao ; Schlesinger, Larry S ; Guerrero-Arguero, Israel ; Pahari, Susanta ; Torrelles, Jordi B ; Lumbreras, Miranda ; Zhang, Hao ; Ye, Chengjin ; Simper, Jan ; Azad, Abul ; Wang, Yufeng ; Maselli, Diego Jose ; Martinez-Sobrido, Luis ; Cai, Hong ; Peters, Jay

Alveolar macrophages (AMs) are unique lung resident cells that contact airborne pathogens and environmental particulates. The contribution of human AMs (HAMs) to pulmonary diseases remains poorly understood due to the difficulty in accessing them from human donors and their rapid phenotypic change during in vitro culture. Thus, there remains an unmet need for cost-effective methods for generating and/or differentiating primary cells into a HAM phenotype, particularly important for translational and clinical studies. We developed cell culture conditions that mimic the lung alveolar environment in humans using lung lipids, that is, Infasurf (calfactant, natural bovine surfactant) and lung-associated cytokines (granulocyte macrophage colony-stimulating factor, transforming growth factor-β, and interleukin 10) that facilitate the conversion of blood-obtained monocytes to an AM-like (AML) phenotype and function in tissue culture. Similar to HAM, AML cells are particularly susceptible to both Mycobacterium tuberculosis and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. This study reveals the importance of alveolar space components in the development and maintenance of HAM phenotype and function and provides a readily accessible model to study HAM in infectious and inflammatory disease processes, as well as therapies and vaccines. IMPORTANCE Millions die annually from respiratory disorders. Lower respiratory track gas-exchanging alveoli maintain a precarious balance between fighting invaders and minimizing tissue damage. Key players herein are resident AMs. However, there are no easily accessible in vitro models of HAMs, presenting a huge scientific challenge. Here, we present a novel model for generating AML cells based on differentiating blood monocytes in a defined lung component cocktail. This model is non-invasive, significantly less costly than performing a bronchoalveolar lavage, yields more AML cells than HAMs per donor, and retains their phenotype in culture. We have applied this model to early studies of M. tuberculosis and SARS-CoV-2. This model will significantly advance respiratory biology research.

2023-08-08·Biophysical journal

Biophysical function of pulmonary surfactant in liquid ventilation.

Article

作者: Xu, Xiaojie ; Zuo, Yi Y ; Li, Guangle

Liquid ventilation is a mechanical ventilation technique in which the entire or part of the lung is filled with oxygenated perfluorocarbon (PFC) liquids rather than air in conventional mechanical ventilation. Despite its many ideal biophysicochemical properties for assisting liquid breathing, a general misconception about PFC is to use it as a replacement for pulmonary surfactant. Because of the high PFC-water interfacial tension (59 mN/m), pulmonary surfactant is indispensable in liquid ventilation to increase lung compliance. However, the biophysical function of pulmonary surfactant in liquid ventilation is still unknown. Here, we have studied the adsorption and dynamic surface activity of a natural surfactant preparation, Infasurf, at the PFC-water interface using constrained drop surfactometry. The constrained drop surfactometry is capable of simulating the intra-alveolar microenvironment of liquid ventilation under physiologically relevant conditions. It was found that Infasurf adsorbed to the PFC-water interface reduces the PFC-water interfacial tension from 59 mN/m to an equilibrium value of 9 mN/m within seconds. Atomic force microscopy revealed that after de novo adsorption, Infasurf forms multilayered structures at the PFC-water interface with an average thickness of 10-20 nm, depending on the adsorbing surfactant concentration. It was found that the adsorbed Infasurf film is capable of regulating the interfacial tension of the PFC-water interface within a narrow range, between ∼12 and ∼1 mN/m, during dynamic compression-expansion cycles that mimic liquid ventilation. These findings have novel implications in understanding the physiological and biophysical functions of the pulmonary surfactant film at the PFC-water interface, and may offer new translational insights into the development of liquid ventilation and liquid breathing techniques.

100 项与卡法克坦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03317	卡法克坦	R07AX	DB06415

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
新生儿呼吸窘迫综合征	马来西亚	-	2018-10-31
新生儿呼吸窘迫综合征	土耳其	-	2018-10-31
呼吸窘迫综合征	美国	ONY, Inc.	1998-07-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
毛细支气管炎	临床2期	美国	ONY Agency LLC	2019-01-12
毛细支气管炎	临床1期	美国	ONY, Inc.	2019-01-12
急性肺损伤	临床1期	美国	-	-
成人呼吸窘迫综合征	药物发现	美国	ONY, Inc.	2017-03-29

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01709409 (CTgov)	临床3期	呼吸窘迫综合征	88	Curosurf-Group1 (Curosurf (Group 1))	齋鹹獵製淵鹽觸艱廠憲(醖衊顧簾憲鏇壓鬱積廠) = 衊糧鏇鬱膚網鑰顧觸艱選淵衊網壓醖廠鑰鏇構 (淵夢願構鹽網鑰憲製壓, 積憲鏇壓淵觸衊獵夢憲 ~ 製鬱築齋願蓋觸壓醖網) 更多	-	2017-10-25
				BLES-group 2 (BLES (Group 2))	齋鹹獵製淵鹽觸艱廠憲(醖衊顧簾憲鏇壓鬱積廠) = 襯艱淵廠夢夢淵築蓋顧選淵衊網壓醖廠鑰鏇構 (淵夢願構鹽網鑰憲製壓, 簾襯獵餘網願繭願願艱 ~ 壓鑰築顧遞壓憲壓鑰範) 更多
NCT00628134 (Pubmed \| J Aerosol Med Pulm Drug Deliv)	N/A	囊性纤维化	8	Calfactant aerosol	範鹹鏇齋顧願襯製範夢(選鑰鹹齋窪鬱廠顧鹽蓋) = 壓鹽願鏇窪壓鑰構鹽鏇獵網觸鑰窪廠衊憲構願 (顧衊淵窪膚範鹹蓋憲鹽 )	-	2012-10-01
				Saline aerosol	範鹹鏇齋顧願襯製範夢(選鑰鹹齋窪鬱廠顧鹽蓋) = 鹹艱膚膚襯獵繭網觸鑰獵網觸鑰窪廠衊憲構願 (顧衊淵窪膚範鹹蓋憲鹽 )
NCT02834624 (CTgov)	N/A	呼吸窘迫综合征	30	calfactant (Calfactant)	夢範繭窪獵築遞簾鹹鏇(壓範簾鹽遞醖淵繭廠鹽) = 鬱糧願淵齋窪廠膚網鏇夢醖遞鏇製觸鏇鑰窪夢 (遞醖齋顧簾醖艱觸鬱餘, 願糧壓鹽艱齋遞鏇觸鹹 ~ 範壓範蓋獵構醖製鏇醖) 更多	-	2017-06-06
				Poractant alfa (Poractant Alfa)	鬱鹽窪襯艱選膚蓋艱範(鑰積鏇製蓋鬱選鬱繭製) = 繭範夢蓋餘願糧餘簾窪鏇蓋顧鹹蓋觸蓋醖廠鬱 (積積艱積蓋淵壓齋鹽餘, 觸鏇範襯夢獵鹹鹹餘願 ~ 醖範積鑰鏇蓋選遞獵襯) 更多