BENITIONSClinical Trial Intelligence

Tiotropium/Salmeterol Inhalation Powder in COPD

Фаза 3 Прекращено NCT00668772

ЗаболеваниеPulmonary Disease, Chronic Obstructive
ФазаФаза 3
СпонсорBoehringer Ingelheim
СтатусПрекращено
Участники207 участн.
ВмешательствоTiotropium/Salmeterol, Salmeterol, Tiotropium
Дата начала15.04.2008
Дата завершения21.11.2008
Публикация результатов16.07.2026

Кратко

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)

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