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| CLIMATE SCIENCE RESEARCH FOR EDUCATORS AND STUDENTS (CSRES): UNDERSTANDING SUN/EARTH/ATMOSPHERE INTERACTIONS | |
| 项目编号 | NNX10AT76A S05 |
| DAVID BROOKS | |
| 项目主持机构 | INSTITUTE FOR EARTH SCIENCE RESEARCH & EDUCATION |
| 开始日期 | 2011 |
| 结束日期 | 2014-12-31 |
| 英文摘要 | Respiratory distress syndrome (RDS) is an acute, severe pulmonary disorder that is the leading cause of morbidity and mortality in preterm infants. It is a major healthcare concern - costs associated with treatment of RDS and its complications exceed $2.4 billion annually in the US. Currently, animal-derived surfactants instilled intratracheally via an endotracheal tube (ETT) are standard of care for treating RDS, in conjunction with mechanical ventilation (MV). ETT intubation and MV are often associated with iatrogenic complications and may lead to bronchopulmonary dysplasia (BPD)/ chronic lung disease (CLD) in these infants. Thus, non-invasive ventilator strategies such as nasal continuous positive airway pressure (nCPAP) are being increasingly employed, but use of nCPAP precludes the use and benefits of early surfactant replacement therapy. Limited success has been achieved in delivering surfactants with currently available aerosol-generating devices. To overcome the critical barrier of effectively aerosolizing surfactant, Discovery Laboratories Inc. (Discovery Labs) is developing an aerosolization technology platform that is specifically designed to noninvasively deliver its proprietary KL4 peptide-containing synthetic surfactant (lucinactant). The objective of developing this "first-in-class" drug-device combination therapy is to obviate the need for ETT intubation to deliver surfactants to preterm infants with or at risk for RDS, and second, avoid the use of animal- derived products in this fragile population. Prototype and first generation aerosol devices and delivery systems have been developed, demonstrating technical feasibility of delivering aerosolized lucinactant;efficacy has also been demonstrated in a preterm animal model (lamb) of RDS. Discovery Labs is currently developing a second generation device, which it plans to take into the clinic. The objective of the Phase I proposal is to fully test this device and conduct characterization of the aerosolized drug product to ensure that it is optimized for delivery to preterm infants. Following completion of Phase I, Discovery Labs intends moving to the Phase II objective of conducting a pilot phase 2a, open-label, multicenter, dose escalation trial in preterm infants with or at risk for RDS. Although beyond the scope of this proposal, an expanded phase 2b study will be conducted, to be followed by a pivotal, Phase 3, which should support submission of an NDA for the dug-device combination product as a therapeutic strategy for prevention and treatment of RDS. |
| 英文关键词 | Acute;aerosolized;Aerosols;Animal Model;Animals;Applications Grants;arm;Blood capillaries;Breathing;Bronchopulmonary Dysplasia;capillary;Chemical Surfactants;Chemicals;Chronic lung disease;Clinic;Clinical Research;Combined Modality Therapy;Complication;cost;design;Development;Devices;Dose;Drug Impurity;drug testing;endotracheal;Engineering;Ensure;Evaluation;Generations;Grant;Healthcare;Infant;Intratracheal Intubation;Intubation;Investigational Drugs;Laboratories;Lead;Lung;Lung diseases;Maximum Tolerated Dose;Mechanical ventilation;meetings;Morbidity - disease rate;Mortality Vital Statistics;nCPAP Ventilation;neonate;novel;open label;Particle Size;Patients;Peptides;Performance;Pharmaceutical Preparations;Pharmacologic Substance;Phase;phase 3 study;Population;Premature Infant;Prevention;Prevention strategy;prototype;Randomized;Replacement Therapy;respiratory distress syndrome;Risk;Safety;Small Business Innovation Research Grant;standard of care;success;surfactant;System;Target Populations;Technology;Testing;Therapeutic;Time;Tube;United States Food and Drug Administration;Ventilator |
| 学科分类 | 11 - 工程与技术;1107 - 航空航天工程;03 - 天文学 |
| 资助机构 | US-NASA |
| 国家 | US |
| 语种 | 英语 |
| 文献类型 | 项目 |
| 条目标识符 | http://gcip.llas.ac.cn/handle/2XKMVOVA/75834 |
| 推荐引用方式 GB/T 7714 | DAVID BROOKS.CLIMATE SCIENCE RESEARCH FOR EDUCATORS AND STUDENTS (CSRES): UNDERSTANDING SUN/EARTH/ATMOSPHERE INTERACTIONS.2011. |
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