Tiotropium/Salmeterol Inhalation Powder in COPD
Phase 3
Terminated
NCT00668772
| Condition | Pulmonary Disease, Chronic Obstructive |
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| Phase | Phase 3 |
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| Sponsor | Boehringer Ingelheim |
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| Status | Terminated |
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| Enrollment | 207 participants |
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| Interventions | Tiotropium/Salmeterol, Salmeterol, Tiotropium |
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| Start date | Apr 15, 2008 |
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| Completion date | Nov 21, 2008 |
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| Results posted | Jul 16, 2026 |
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Summary
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) |
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| Tiotropium (Tio18GEL) | 1.480 ± 0.390 Litres (L) |
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| Salmeterol (Salm25PE) | 1.413 ± 0.408 Litres (L) |
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| FDC Tiotropium / Salmeterol + Salmeterol (T+S_PE / S25PE) | 1.584 ± 0.542 Litres (L) |
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| Placebo | 1.031 ± 0.391 Litres (L) |
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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) |
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| Tiotropium (Tio18GEL) | 1.526 ± 0.488 Litres (L) |
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| Salmeterol (Salm25PE) | 1.496 ± 0.472 Litres (L) |
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| FDC Tiotropium / Salmeterol + Salmeterol (T+S_PE / S25PE) | 1.655 ± 0.510 Litres (L) |
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| Placebo | 1.239 ± 0.429 Litres (L) |
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Open in BENITIONS
View on ClinicalTrials.gov
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