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This study will measure the effect of repeat inhaled doses of GW870086X on lung function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 28 day repeat dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW870086X | Drug | Investigational product |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function as measured by FEV1 | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function as measured by FEV1 | Day 7 and 14 | |
| Lung function as measured by PEFR | Twice daily over 28 days | |
| Rescue medication usage |
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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 | Rüdersdorf | Brandenburg | 15562 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23991670 | Derived | Bareille P, Hardes K, Donald AC. Efficacy and safety of once-daily GW870086 a novel selective glucocorticoid in mild-moderate asthmatics: a randomised, two-way crossover, controlled clinical trial. J Asthma. 2013 Dec;50(10):1077-82. doi: 10.3109/02770903.2013.837480. Epub 2013 Oct 1. |
| Label | URL |
|---|---|
| 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 |
| ID | Type | URL | Comment |
|---|---|---|---|
| 112851 | Dataset Specification | 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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 28, 2017 | |
| Reset | Feb 16, 2018 | |
| Release | Mar 5, 2018 | |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 28, 2017 | Feb 16, 2018 | |||
| Mar 5, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C581038 | GW870086X |
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| Drug |
Placebo control |
|
| 4-5 months |
| Assess safety and tolerability | 4-5 months |
| Frankfurt am Main |
| Hesse |
| 60596 |
| Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Geesthacht | Schleswig-Holstein | 21502 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10367 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10717 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10787 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 14057 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112851 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112851 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112851 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112851 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112851 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112851 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |