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| ID | Type | Description | Link |
|---|---|---|---|
| 1205.9001 | Other Identifier | Boehringer Ingelheim |
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Main study: To investigate safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of BEA 2180 BR Sub-study; To investigate whether treatment with 36 μg tiotropium bromide is able to protect of methacholine-induced bronchoconstriction compared to baseline (methacholine challenge at screening).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BEA 2180 BR | Experimental | single rising doses |
|
| Placebo | Placebo Comparator |
| |
| Sub-Study | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEA 2180 BR | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with clinically significant changes in vital signs | blood pressure, pulse rate, respiratory rate, oral body temperature | up to 14 days after last drug administration |
| Number of subjects with clinically significant changes in laboratory parameters | up to 14 days after last drug administration | |
| Changes from baseline in airway resistance (Raw) | assessed by body plethysmography | up to 120 hours after drug administration |
| Changes from baseline in specific airway conductance (sGaw) | assessed by body plethysmography | up to 120 hours after drug administration |
| Number of subjects with clinically significant findings in 12-lead ECG (electrocardiogram) | up to 14 days after last drug administration | |
| Number of subjects with adverse events | up to 14 days after last drug administration | |
| Assessment of tolerability by investigator on a 5-point scale | within 14 days after last drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in salivary secretion | up to 24 hours after drug administration | |
| Changes from baseline in pupil diameter of each eye | pupillometry | up to 4 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria specific for this study:
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| ID | Term |
|---|---|
| D016210 | Methacholine Chloride |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D008688 | Methacholine Compounds |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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|
| Respimat® A 4 | Device |
|
| Methacholine Chloride | Drug | methacholine challenge test |
|
| Spiriva | Drug |
|
|
| Maximum measured concentration of the analyte in plasma (Cmax) | up to 240 hours after drug administration |
| Measured concentration of the analyte in plasma (C) for several time points | up to 24 hours after drug administration |
| Time from dosing to the maximum concentration of the analyte in plasma (tmax) | up to 240 hours after drug administration |
| Amount of parent drug that is eliminated in urine (Ae) | up to 312 hours after drug administration |
| Fraction of administered drug excreted unchanged in urine (fe) | up to 312 hours after drug administration |
| Area under the concentration-time curve of the analyte in plasma (AUC) | up to 240 hours after drug administration |
| Renal clearance of the analyte (CLR) | up to 312 hours after drug administration |
| Terminal rate constant of the analyte in plasma (λZ) | up to 240 hours after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | up to 240 hours after drug administration |
| Mean residence time of the analyte in the body after inhaled administration (MRTinh) | up to 240 hours after drug administration |
| Apparent clearance of the analyte in plasma following extravascular administration (CL/F) | up to 240 hours after drug administration |
| Apparent volume of distribution during the terminal phase λz following an extravascular dose (VZ/F) | up to 240 hours after drug administration |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |