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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023780-18 | EudraCT Number | EudraCT |
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The primary objective is to compare the systemic exposure to tiotropium and CD 1857 after treatment with the fixed dose combination (fixed dose combination (FDC), Treatment A) of tiotropium plus BI 54903 (ethanolic solution for inhalation (EIS), Respimat (RMT) B) with the systemic exposure following inhalation of the free combination (Treatment B) of tiotropium (aqueous solution for inhalation (AIS), RMT A) plus BI 54903 (EIS, RMT B), when administered once-daily over 21 days via Respimat(R) (RMT).
The secondary objectives are:
to compare the systemic exposure to tiotropium and CD 1857 after single dose administration of FDC and of the free combination of tiotropium/BI 54903 to compare the systemic exposure to BI 54903 after a single dose and at steady state after multiple doses of the FDC and of the free combination of tiotropium/BI 54903 to compare the safety and tolerability of tiotropium and BI 54903 when administered as FDC and as free dose combination, respectively
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Tiotropium medium dose | Experimental | Oral inhalation daily for 21 days |
|
| Treatment A: BI 54903 high dose | Experimental | Oral inhalation daily for 21 days |
|
| Treatment B: Tiotropium medium dose | Experimental | Oral inhalation daily for 21 days |
|
| Treatment C: BI 54903 high dose | Experimental | Oral inhalation daily for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug | Medium dose of oral inhalation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve of CD 1857 in plasma over a uniform dosing interval Ï„ (AUCÏ„,ss) | on several time points until day 22 | |
| Maximum concentration of CD 1857 in plasma at steady state (Cmax,ss) | on several time points until day 22 | |
| AUCÏ„,ss for Tiotropium | on several time points until day 22 | |
| Cmax,ss for Tiotropium | on several time points until day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss for BI 54903 | on several time points until day 22 | |
| Cmax,ss for BI 54903 | on several time points until day 22 | |
| Ae0-24 (Amount of analyte that is eliminated in urine) for tiotropium |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1298.2.1 Boehringer Ingelheim Investigational Site | Ingelheim | Germany |
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| Tiotropium |
| Drug |
Medium dose of oral inhalation |
|
| BI 54903 | Drug | Medium dose of oral inhalation |
|
| BI 54903 | Drug | Medium dose of oral inhalation |
|
| on Day 1 and 21 |
| Change in physical examination | 9 weeks |
| Change in vital signs | 9 weeks |
| Change in 12-lead electrocardiogram | 9 weeks |
| Change in clinical laboratory tests | 9 weeks |
| Occurrence of Adverse Events | 9 weeks |
| Assessment of tolerability by the investigator | 9 weeks |
| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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