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To investigate the dose response following single inhalation of Ba 679 BR inhalation powder in COPD patients using pulmonary functions as indicators, and to compare data obtained with overseas study findings
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ba 679 BR low dose | Experimental |
| |
| Placebo inhalation powder | Placebo Comparator |
| |
| Ba 679 BR middle dose | Experimental |
| |
| Ba 679 BR high dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ba 679 BR low dose | Drug |
| ||
| Ba 679 BR middle dose |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1.0 max (maximum forced expiratory volume in one second) | before and up to 24 hours after each study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1.0 AUC 0-24 (forced expiratory volume in one second as area under the curve 0 to 24 hours after administration) | before and up to 24 hours after each study drug administration | |
| FEV1.0 time to response | before and up to 24 hours after each study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Ba 679 BR high dose | Drug |
|
| Placebo inhalation powder | Drug |
|
| FEV1.0 Tmax (time to FEV1.0 max) | before and up to 24 hours after each study drug administration |
| FEV1.0 at measuring time points up to 24 hours after administration of study drug | before and up to 24 hours after each study drug administration |
| FVC AUC 0-24 (forced vital capacity as area under the curve 0 to 24 hours after administration) | before and up to 24 hours after each study drug administration |
| FVC max | before and up to 24 hours after each study drug administration |
| FVC at measuring time points up to 24 hours after administration of study drug | before and up to 24 hours after each study drug administration |
| Occurrence of adverse events | up to 29 days |
| Changes in blood pressure | before and up to 24 hours after each study drug administration |
| Changes in pulse rate | before and up to 24 hours after each study drug administration |
| Changes in transdermal O2 saturation | before and up to 24 hours after each study drug administration |
| Abnormal findings in electrocardiogram (ECG) | before and 1.5 and 24 hours after each administration of study drug |
| Abnormal changes in laboratory measurements | at 24 hours after last study drug administration |
| Urinary excretion rate | before (from 4 hours pre-dosing until immediately before dosing) and 0-2, 2-4, 4-8, 8-12 and 12-24 hours after drug administration |
| MMEF AUC 0-24 (maximal midexpiratory flow as area under the curve 0 to 24 hours after administration) | before and up to 24 hours after each study drug administration |
| MMEF max | before and up to 24 hours after each study drug administration |
| MMEF at measuring time points up to 24 hours after administration of study drug | before and up to 24 hours after each study drug administration |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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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