A 2-Month Safety Follow-up Trial of Subjects From MannKind Protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 649
- 试验地点
- 147
- 主要终点
- Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126
研究概览
简要总结
The main purpose of the trial is to evaluate pulmonary function in subjects who had completed any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an additional 2-month safety follow-up.
详细描述
This was a 2-month safety follow-up study of subjects from MannKind protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030. No study medications were administered during this trial. The adverse event data included are for the combined Safety population irrespective of previous treatments in the parent trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have completed any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030)
- •Urine cotinine test of less than or equal to 100 ng/mL
- •Written informed consent
排除标准
- •Subjects who started smoking during the 4 week follow-up phase of the parent trial
- •Subjects who began a new inhaled insulin regimen with an investigational drug during the 4 week follow-up phase of the parent trial and/or are participation in another clinical trial
- •Female subjects who are pregnant, lactating or planning on becoming pregnant
- •Subjects with a positive urine drug screening at Visit 1
- •Female subjects of child-bearing potential not practicing adequate birth control
研究组 & 干预措施
Ex-TI
Ex-Technosphere® Insulin Inhalation Powder (subjects previously received TI Inhalation Powder)
干预措施: Technosphere Insulin Inhalation Powder (Drug)
Non Ex-TI
Non Ex-Technosphere® Insulin Inhalation Powder (subjects previously received another anti-diabetic medication)
干预措施: Comparator (Drug)
结局指标
主要结局
Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126
时间窗: 9 to 27 months
次要结局
- Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126(9 to 27 months)
- Change in Hemoglobin Corrected DLco (mL/min/mm Hg) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126(9 to 27 months)
- Change in FVC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126(9 to 27 months)
- Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126(3 Months)
- Change in FEV1 (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126(3 Months)
- Change in TLC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126(3 Months)
- Change in Hemoglobin Corrected DLco (mL/min/mmHg) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126(3 Months)