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This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects.
Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW642444 50mcg | Experimental |
| |
| GW642444 100mcg | Experimental |
| |
| GW642444 200mcg | Experimental |
| |
| salmeterol 50mcg | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW642444 | Drug | drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 at 24 hours after a single dose. | 24 hours on 4 separate occasions |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 - Days 1 and 7 | Days 1 and 7 on 4 separate occasions | |
| Mean morning/evening PEFR | Days 3-8 on 4 separate occasions | |
| BP, HR & QTc on Days 1 and 7 |
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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 | Wiesbaden | Hesse | 65187 | Germany | ||
| GSK Investigational Site |
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| 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 |
|---|---|---|---|
| B2C101762 | 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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| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Placebo |
| Drug |
placebo |
|
| salmeterol 50mcg | Drug | salmeterol |
|
| Days 1 and 7 on 4 separate occasions |
| Potassium and glucose on Days 1 and 7 | Days 1 and 7 on 4 separate occasions |
| safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG | throughout study |
| PK parameters | Days 1, 4 and 7 on 4 separate occasions |
| Großhansdorf |
| Schleswig-Holstein |
| 22927 |
| Germany |
| GSK Investigational Site | Gothenburg | SE-413 45 | Sweden |
For additional information about this study please refer to the GSK Clinical Study Register |
| B2C101762 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C101762 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C101762 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C101762 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C101762 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C101762 | Clinical Study Report | 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 |
| Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |