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A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is being developed for once daily administration for the maintenance treatment of asthma and COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and compared with GW642444M and GW685698X administered separately in order to determine whether co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics of either compound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 | Experimental | study drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW685698X & GW642444M | Drug | study drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum heart rate | over 4 hours after dosing. | |
| Blood pressure | changes over 12 hours. | |
| Electrocardiogram | changes over 12 hours. | |
| Change in peak expiry flow rate | changes over 24 hours. | |
| Change in serum cortisol concentration | changes over 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma drug concentration (AUC, Cmax, t1/2, tmax) | over 48 hours after dosing. | |
| Change in blood potassium levels | within 4 hours of drug dosing. | |
| Mean heart rate |
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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 | Randwick, Sydney | New South Wales | 2031 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | This study has not been published in the scientific literature. | ||
| 27127998 | Derived | Kempsford R, Allen A, Bareille P, Hamilton M, Cheesbrough A. The pharmacodynamics, pharmacokinetics, safety and tolerability of inhaled fluticasone furoate and vilanterol administered alone or simultaneously as fluticasone furoate/vilanterol. Clin Pharmacol Drug Dev. 2015 Jan;4(1):2-11. doi: 10.1002/cpdd.160. Epub 2014 Dec 5. |
| 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 |
|---|---|---|---|
| HZA105871 | Informed Consent 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 |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| over 4 hours after dosing |
| Results for study HZA105871 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| HZA105871 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA105871 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA105871 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA105871 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA105871 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA105871 | Statistical Analysis Plan | 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 |