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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000935-98 | EudraCT Number | EudraCT |
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The aim of the study is to establish the olodaterol dose in the ethanolic fixed dose combination (FDC) with BI 54903 which is equivalent in bronchodilator effect and systemic exposure to the 5 µg olodaterol reference dose in the aqueous inhalation solution (AIS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + BI 54903 | Placebo Comparator | patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B" |
|
| Olodaterol low dose + BI54903 | Experimental | patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B" |
|
| Olodaterol medium dose + BI54903 | Active Comparator | patient to receive 2 puffs of each device |
|
| Olodaterol high dose + BI54903 | Experimental | patient to receive 2 puffs of each device |
|
| Olodaterol l dose + BI54903 | Experimental | patient to receive 2 puffs of each device |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respimat | Device | aqueous and ethanolic solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 (AUC0-12h) FEV1 = Forced expiratory volume in one second, AUC = area under the curve | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 (AUC0-24h) | 24 hours | |
| FEV1 (AUC12-24h) | 12 hours | |
| Peak FEV1 |
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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 |
|---|---|---|---|---|---|---|
| 1249.7.33003 Boehringer Ingelheim Investigational Site | Gières | France |
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| Olodaterol m dose + BI54903 | Experimental | patient to receive 2 puffs of each device |
|
| Olodaterol h dose + BI54903 | Experimental | patient to receive 2 puffs of each device |
|
| Respimat |
| Device |
aqueous and ethanolic solution |
|
| Respimat | Device | aqueous and ethanolic solution |
|
| Respimat | Device | aqueous and ethanolic solution |
|
| Respimat | Device | aqueous and ethanolic solution |
|
| Respimat | Device | aqueous and ethanolic solution |
|
| Respimat | Device | aqueous and ethanolic solution |
|
| Olodaterol | Drug | aqueous solution |
|
| Olodaterol | Drug | aqueous solution |
|
| Olodaterol | Drug | aqueous solution |
|
| Olodaterol | Drug | aqueous solution |
|
| Olodaterol | Drug | aqueous solution |
|
| Olodaterol | Drug | aqueous solution |
|
| Olodaterol | Drug | aqueous solution |
|
| Olodaterol & BI54903 | Drug | ethanolic solution |
|
| Olodaterol & BI54903 | Drug | ethanolic solution |
|
| Olodaterol & BI54903 | Drug | ethanolic solution |
|
| Olodaterol & BI54903 | Drug | ethanolic solution |
|
| Olodaterol & BI54903 | Drug | ethanolic solution |
|
| Olodaterol & BI54903 | Drug | ethanolic solution |
|
| Olodaterol & BI54903 | Drug | ethanolic solution |
|
| BI54903 | Drug | ethanolic solution |
|
| BI54903 | Drug | ethanolic solution |
|
| BI54903 | Drug | ethanolic solution |
|
| BI54903 | Drug | ethanolic solution |
|
| BI54903 | Drug | ethanolic solution |
|
| BI54903 | Drug | ethanolic solution |
|
| BI54903 | Drug | ethanolic solution |
|
| 12 hours |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C549647 | olodaterol |
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