CLINICAL TRIAL: TETRASODIUM IN PATIENTS WITH MILD CYSTIC FIBROSIS LUNG DISEASE

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项多中心、随机、双盲、安慰剂对照的第三阶段研究，将检验在相对健康的囊性纤维化(CF)患者群体中，地诺福索作为一种相对于安慰剂改善肺功能的早期干预疗法。 符合条件的患者将被随机分配，每天接受60毫克地那福索或安慰剂三次治疗，疗程为24周。在这项研究的24周安慰剂对照部分完成后，所有患者将在安全延长期内再接受24周的安全延长期，每天三次，每次60毫克。 本研究的目的是与安慰剂相比，观察单剂剂量的地那福索对轻度慢性肺病患者的安全性和有效性。这项研究中的安慰剂是一种无菌盐水(盐水)溶液。 这项研究的另一个目的是确定与安慰剂相比，人体如何吸收和处理地那福索。研究的这一部分将确定是否存在可在吸入度磺胺醇吸入液的前半段时间内在血液中测量到的度那福索水平(PK=药代动力学)。 学习。

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. This is a multicenter, randomized, double-blind, placebo-controlled Phase III study that will examine denufosol as an early intervention therapy to improve lung function relative to placebo in a relatively healthy Cystic Fibrosis (CF) patient population. Eligible patients will be randomized to receive either denufosol 60 mg or placebo three times daily for a 24-week treatment period. At the completion of the 24-week placebo-controlled portion of this study, all patients will receive 60 mg denufosol three times daily for an additional 24 weeks in a safety extension period. The purpose of this study is to investigate the safety and effectiveness of one dose strength of denufosol compared to placebo in patients with mild CF lung disease. The placebo in this study is a sterile saline (salt water) solution. Another purpose of this study is to determine how the body absorbs and processes denufosol compared to placebo. This part of the study will determine if there are levels of denufosol that can be measured in the blood (PK= pharmacokinetics) after breathing in denufosol inhalation solution during the first half of the study.