BENITIONSClinical Trial Intelligence

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)
Placebo1.031 ± 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)
Placebo1.239 ± 0.429 Litres (L)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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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。