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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项多中心、随机、双盲、安慰剂对照的III期研究，将在相对健康的囊性纤维化（CF）患者人群中检查地努福索作为早期干预治疗，相对于安慰剂改善肺功能。 符合条件的患者将随机接受denufosol 60 mg或安慰剂，每日3次，治疗24周。在本研究的24周安慰剂对照部分完成时，所有患者将在安全性延长期内接受60 mg地纽福索，每日三次，持续额外的24周。 本研究的目的是在轻度CF肺病患者中研究地努福索单剂量规格与安慰剂相比的安全性和有效性。本研究中的安慰剂是无菌生理盐水（盐水）溶液。 本研究的另一个目的是确定与安慰剂相比，身体如何吸收和处理denufosol。这部分研究将确定在研究的前半部分期间，在吸入地纽福索吸入溶液后，是否存在可以在血液中测量的地纽福索水平（PK=药代动力学）。 study.

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.