NCT01798914
No Longer Available
不适用
Patient Transfer Program for Transitioning From Exubera® (Insulin Human [rDNA Origin]) Inhalation Powder to Technosphere® Insulin (Insulin Human [rDNA Origin]) Inhalation Powder
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Type 1 Diabetes
- 发起方
- Mannkind Corporation
- 试验地点
- 14
- 状态
- No Longer Available
- 最后更新
- 10年前
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needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.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
研究者
入排标准
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
结局指标
主要结局
未指定
研究点 (14)
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