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This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | 100mcg 719 |
|
| Active 2 | Experimental | 500mcg '719 |
|
| Active 3 | Experimental | 1000mcg '719 |
|
| Placebo | Placebo Comparator | Placebo '719 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100mcg | Drug | 100mcg '719 |
| |
| 500mcg |
| Measure | Description | Time Frame |
|---|---|---|
| General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests | Various |
| Measure | Description | Time Frame |
|---|---|---|
| Blood and urine levels of study drug | various |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Antwerp | 2060 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23881566 | Derived | Cahn A, Mehta R, Preece A, Blowers J, Donald A. Safety, tolerability and pharmacokinetics and pharmacodynamics of inhaled once-daily umeclidinium in healthy adults deficient in CYP2D6 activity: a double-blind, randomized clinical trial. Clin Drug Investig. 2013 Sep;33(9):653-64. doi: 10.1007/s40261-013-0109-6. |
| Label | URL |
|---|---|
| Results for study 110106 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 110106 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Drug |
500mcg '719 |
|
| 1000mcg | Drug | 1000mcg '719 |
|
| Placebo | Drug | Placebo '719 |
|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110106 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110106 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110106 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110106 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110106 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110106 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |