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The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily in uncontrolled asthmatic subjects > or = 18 years of age over the course of 6 weeks treatment.
The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 18 years of age over the course of 6 weeks treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM) | Experimental | FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM) |
|
| FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM) | Active Comparator | FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM) |
|
| FP/SAL 250/50mcg BID plus placebo BID | Placebo Comparator | P/SAL 250/50mcg BID plus placebo BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FP/SAL 250/50mcg BID | Drug | FP/SAL 250/50mcg BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough (AM pre-dose and pre-rescue bronchodilator) FEV1 | at the end of the 6 week treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| • Daily trough (AM pre-dose and pre-rescue bronchodilator) AM PEF | averaged over the last 3 weeks of the 6 week treatment period. | |
| • Daily PM PEF | averaged over the last 3 weeks of the 6 week treatment period. |
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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 | Pleven | 5800 | Bulgaria | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24010736 | Derived | Snowise NG, Clements D, Ho SY, Follows RM. Addition of a 5-lipoxygenase-activating protein inhibitor to an inhaled corticosteroid (ICS) or an ICS/long-acting beta-2-agonist combination in subjects with asthma. Curr Med Res Opin. 2013 Dec;29(12):1663-74. doi: 10.1185/03007995.2013.842163. Epub 2013 Sep 19. |
| 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 |
|---|---|---|---|
| 114387 | 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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 2, 2017 | |
| Reset | Feb 5, 2018 | |
| Release | Feb 13, 2018 |
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| GSK2190915 200mg QD (AM) | Drug | GSK2190915 200mg QD (AM) |
|
| GSK2190915 100mg QD (AM) | Drug | GSK2190915 100mg QD (AM) |
|
| Montelukast 10mg QD (PM) | Drug | Montelukast 10mg QD (PM) |
|
| Placebo tablets (2) (AM) | Drug | Placebo tablets (2) (AM) |
|
| Placebo capsule (PM) | Drug | Placebo capsule (PM) |
|
| • Daily (average of AM and PM) | averaged over the last 3 weeks of the 6 week treatment period |
| • Daily asthma symptom score | averaged over the last 3 weeks of the 6 week treatment period. |
| • Daily rescue salbutamol use | averaged over the last 3 weeks of the 6 week treatment period. |
| • Percentage of symptom-free days | during the last 3 weeks of the 6 week treatment period. |
| • Percentage of symptom-free nights | during the last 3 weeks of the 6 week treatment period. |
| • Percentage of rescue-free days | during the last 3 weeks of the 6 week treatment period. |
| • Percentage of rescue-free nights | during the last 3 weeks of the 6 week treatment period. |
| • Percentage of nights without awakenings due to asthma | during the last 3 weeks of the 6 week treatment period. |
| • Proportion of subjects withdrawn due to lack of efficacy | during the last 3 weeks of the 6 week treatment period. |
| Rousse |
| 7000 |
| Bulgaria |
| GSK Investigational Site | Varna | 9010 | Bulgaria |
| GSK Investigational Site | Bialystok | 15-084 | Poland |
| GSK Investigational Site | Lodz | 93-329 | Poland |
| GSK Investigational Site | Tarnów | 33-100 | Poland |
| GSK Investigational Site | Dnipropetrovsk | 49027 | Ukraine |
| GSK Investigational Site | Dnipropetrovsk | 49051 | Ukraine |
| GSK Investigational Site | Donetsk | 83099 | Ukraine |
| GSK Investigational Site | Ivano-Frankivsk | 76018 | Ukraine |
| GSK Investigational Site | Kharkiv | 61035 | Ukraine |
| GSK Investigational Site | Kharkiv | 61037 | Ukraine |
| GSK Investigational Site | Kiev | 03680 | Ukraine |
| GSK Investigational Site | Kiev | 3680 | Ukraine |
| GSK Investigational Site | Kyiv | 02091 | Ukraine |
| GSK Investigational Site | Kyiv | 02232 | Ukraine |
| GSK Investigational Site | Kyiv | 03115 | Ukraine |
| GSK Investigational Site | Kyiv | 04107 | Ukraine |
| GSK Investigational Site | Zaporizhia | 69035 | Ukraine |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114387 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114387 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114387 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114387 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114387 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114387 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 2, 2017 | Feb 5, 2018 | |||
| Feb 13, 2018 | Aug 15, 2018 |
| 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 |
|---|---|
| C494814 | BID protein, human |
| C552410 | 3-(3-tert-butylsulfanyl-1-(4-(6-ethoxypyridin-3-yl)benzyl)-5-(5-methylpyridin-2-ylmethoxy)-1H-indol-2-yl)-2,2-dimethylpropionic acid |
| C093875 | montelukast |
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