Patient Transfer Program for Transitioning From Exubera® (Insulin Human [rDNA Origin]) Inhalation Powder to Technosphere® Insulin (Insulin Human [rDNA Origin]) Inhalation Powder

Mannkind Corporation14 个研究点分布在 1 个国家开始时间: 2008年10月最近更新: 2016年1月20日

适应症

试验速览

阶段: 不适用
状态: No Longer Available
发起方: Mannkind Corporation
试验地点: 14

研究概览入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to allow patients with specific needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.

详细描述

A Phase 3, open label, multicenter, safety follow up trial to convert the treatment of subjects currently using Exubera to treatment with TI Inhalation Powder

研究设计

研究类型: Expanded Access

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Subject has type 1 or type 2 diabetes mellitus and is currently being treated with or has been treated with Exubera.
•Subject has a severe phobia to sc injections of insulin (needle phobia) preventing conventional treatment OR has impaired sc insulin absorption

排除标准

•Smoking in the previous 6 months
•History of asthma or chronic obstructive pulmonary disease (COPD) or any other significant pulmonary disease, or exposure to pulmonary toxins.
•Clinically significant pulmonary abnormalities on chest high-resolution computed tomography (HRCT).
•PFT results prior to transferring to TI Inhalation Powder showing any of the following: FEV1 < 70% of predicted, FVC < 70% of predicted, DLCO < 70% of predicted, TLC < 80% of predicted.
•Allergy to insulin

研究者

发起方

Mannkind Corporation

申办方类型

Industry

责任方

Sponsor

研究点 (14)

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