Tiotropium/Salmeterol Inhalation Powder in COPD
3期
提前终止
NCT00668772
| 适应症 | Pulmonary Disease, Chronic Obstructive |
|---|
| 分期 | 3期 |
|---|
| 申办方 | Boehringer Ingelheim |
|---|
| 状态 | 提前终止 |
|---|
| 受试者人数 | 207 人 |
|---|
| 干预(药物) | Tiotropium/Salmeterol, Salmeterol, Tiotropium |
|---|
| 开始日期 | 2008年4月15日 |
|---|
| 完成日期 | 2008年11月21日 |
|---|
| 结果公布日 | 2026年7月16日 |
|---|
摘要
The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index (BDI)/Transition Dyspnoea Index (TDI), the effect on health status as determined by the St George Respiratory Questionnaire (SGRQ) and the effect on chronic obstructive pulmonary disease (COPD) exacerbations
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period
At baseline and week 12 · Litres (L)
| FDC Tiotropium / Salmeterol (T+S_PE) | 1.412 ± 0.317 Litres (L) |
|---|
| Tiotropium (Tio18GEL) | 1.480 ± 0.390 Litres (L) |
|---|
| Salmeterol (Salm25PE) | 1.413 ± 0.408 Litres (L) |
|---|
| FDC Tiotropium / Salmeterol + Salmeterol (T+S_PE / S25PE) | 1.584 ± 0.542 Litres (L) |
|---|
| Placebo | 1.031 ± 0.391 Litres (L) |
|---|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period
At baseline and week 24
Forced Expiratory Volume in One Second (FEV1) Area Under the Concentration-time Curve From 0 to 8h (AUC0-8h) Response at the End of the 12-week Treatment Period
At baseline and at week 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose. · Litres (L)
| FDC Tiotropium / Salmeterol (T+S_PE) | 1.630 ± 0.395 Litres (L) |
|---|
| Tiotropium (Tio18GEL) | 1.526 ± 0.488 Litres (L) |
|---|
| Salmeterol (Salm25PE) | 1.496 ± 0.472 Litres (L) |
|---|
| FDC Tiotropium / Salmeterol + Salmeterol (T+S_PE / S25PE) | 1.655 ± 0.510 Litres (L) |
|---|
| Placebo | 1.239 ± 0.429 Litres (L) |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
同一适应症的其他试验
全部试验
本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。