DENUFOSOL TETRASODIUM INHALATION SOLUTION IN PATIENTS WITH MILD CF

地纽福索四钠吸入溶液用于轻度 CF 患者

• 批准号: 7625675
• 负责人: George Z Retsch-Bogart
• 金额: $ 0.28万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7625675
• 关键词: Agonist; Breathing; Chronic; Computer Retrieval of Information on Scientific Projects Database; Daily; Dose; Double-Blind Method; Early Intervention; Funding; Generations; Grant; INS37217; Institution; Label; Lung; Mucociliary Clearance; Nebulizer; P2Y2 receptor; Patients; Phase III Clinical Trials; Placebo Control; Placebos; Population; Pulmonary Cystic Fibrosis; Randomized; Recurrence; Relative (related person); Research; Research Personnel; Resources; Respiratory physiology; Safety; Solutions; Source; Therapeutic Intervention; Time; United States National Institutes of Health; Week; cystic fibrosis patients; denufosol tetrasodium; health related quality of life; improved; novel

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Denufosol tetrasodium (INS37217) is a novel second-generation, chemically stable, selective P2Y2 receptor agonist that may have the ability to restore or maintain mucociliary clearance in patients early in the course of CF lung disease, which may therefore preserve lung function and lessen the inevitable recurrent cycles of pulmonary bacterial colonization, pulmonary exacerbations, and chronic lung function decline. This multicenter, randomized, double-blind, placebo-controlled Phase 3 study will examine denufosol as an early intervention therapy to improve lung function relative to placebo in a relatively healthy CF patient population. The objectives of this study are to evaluate the efficacy, safety and tolerability of a 60 mg nebulizer dose of denufosol compared to placebo when administered three times daily over 24 weeks (and for an additional 24 weeks in an open label period) in patients with mild CF lung disease and to evaluate health-related quality of life in patients with mild CF lung disease participating in this trial.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 Denuposol四钠（INS37217）是一种新型的第二代，化学稳定的，选择性的P2Y2受体激动剂，可能具有恢复或维持CF肺病过程中患者的粘膜循环清除能力，因此可以保留肺部的肺部，并减少不可避免的复发性脉络化脉络化的脉络化脉络化量表，并将其切成般的脉络化脉络化量表，并将其切实可行的孔子化量化脉络化及其孔子化的孔子化量表及其性化量。 衰退。这项多中心，随机，双盲，安慰剂对照的第三阶段研究将研究DENUFOSOL作为早期干预疗法，以改善相对健康的CF患者人群中相对于安慰剂的肺功能。 这项研究的目的是评估与安慰剂60 mg雾化剂剂量与安慰剂相比的功效，安全性和耐受性，每天在24周内服用3次（在开放式标签期内额外24周）对轻度CF肺部病患者进行了轻度CF肺部疾病的患者的健康相关质量，以评估这项轻度CF肺疾病患者的健康相关质量。