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GW642444 (the study medicine) is a new experimental medicine for treating asthma and chronic obstructive pulmonary disease (COPD). People with asthma and COPD suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become narrow. We hope that the study medicine will work by relaxing the muscles in the airways and help to keep the airways open, and make breathing easier. The study medicine might improve on available treatments by having fewer side-effects, and by working faster and for longer, so that patients could take it once daily, instead of twice daily.
When a medicine is made into a form ready to be given to patients, inactive ingredients are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In this study, the study medicine contains the inactive ingredient magnesium stearate.
We need to check that the study medicine doesn't cause problems when inhaled along with magnesium stearate. So, we're doing this study in healthy people to find out the answers to these questions.
1)Do repeated once-daily doses of the study medicine cause any important side effects when inhaled, along with magnesium stearate, as a fine powder? 2)How much of the study medicine gets into the bloodstream and how long does the body take to get rid of it?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW642444M 25mcg | Experimental | In Cohort 1 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 25 mcg. |
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| GW642444M 50mcg | Experimental | Subjects after randomization will receive two inhalations of 25 mcg GW642444M in Cohort 1. |
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| GW642444M 100mcg | Experimental | In Cohort 2 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 100 mcg. |
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| GW642444M 200mcg | Experimental | Subjects after randomization will receive two inhalations of 100 mcg GW642444M in Cohort 2. |
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| GW642444M 400mcg | Experimental | Subjects after randomization will receive two inhalations of 200 mcg GW642444M in Cohort 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW642444M for 14 days | Drug | M salt |
|
| Measure | Description | Time Frame |
|---|---|---|
| General safety and tolerability as measured by ECG, blood pressure, pulse rate and blood and urine tests. Repeated measures on Day 1, 7 and 14 | Repeated measures on Day 1, 7 and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of the medicine on the body as measured by potassium and glucose levels in the blood. Monitoring of the study medicine in the body by analysis of blood samples. Repeated measures on Day 1, 7 and 14 | Repeated measures on Day 1, 7 and 14 |
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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 | London | NW10 7NS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23232038 | Background | Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther. 2013 Apr;26(2):256-64. doi: 10.1016/j.pupt.2012.12.001. Epub 2012 Dec 8. |
| 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 |
|---|---|---|---|
| B2C108784 | Statistical Analysis Plan | 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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| Results for study B2C108784 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 |
| B2C108784 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C108784 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C108784 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C108784 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C108784 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C108784 | Informed Consent Form | 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 |