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This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. When a medicine is made into a form ready to be given to patients, the active ingredient is often prepared with another ingredient called a salt to help make it stable, and 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 previous studies the study drug has been given as a dry powder containing either the "H" salt (with the inactive ingredient lactose), or containing the "M" salt (with the inactive ingredients lactose and cellobiose octaacetate). The "M" salt form of the study drug has been altered to contain lactose and a new inactive ingredient called magnesium stearate (instead of cellobiose octaacetate).
Participants in this study will receive both the "H" salt (GW642444H) and the new "M" salt (GW642444M) containing magnesium stearate. This study will be the first time the new "M" salt form of the study drug will be given to asthmatic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW642444M 25mcg | Experimental | Subject will inhale single dose of GW642444M 25 mcg via a DISKUS device in morning. |
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| GW642444M 100mcg | Experimental | Subject will inhale single dose of GW642444M 100 mcg via a DISKUS device in morning. |
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| GW642444M 400mcg | Experimental | Subject will inhale single dose of GW642444M 400 mcg via a DISKUS device in morning. |
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| GW642444H 100mcg | Experimental | Subject will inhale single dose of GW642444H 100 mcg via a DISKUS device in morning. |
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| placebo | Placebo Comparator | Subject will inhale single dose of Placebo via a DISKUS device in morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW642444H (100mcg) | Drug | H salt |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| General safety and tolerability of the new formulation of GW642444 as measured by ECG, blood pressure, pulse rate and blood and urine tests. Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks). | Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Airways relaxation assessed by lung function tests. Effect of study medicine on the body and amount of medicine in the body measured by potassium, glucose and medicine in blood samples. Measurements made over 24 hours on 5 occasions (1-2 weeks apart). | Measurements made over 24 hours on 5 occasions (1-2 weeks apart). |
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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 | Harrow | Middlesex | HA1 3UJ | United Kingdom | ||
| GSK Investigational Site |
| 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 |
|---|---|
| Results for study B2C106996 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| B2C106996 | 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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| 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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| Drug |
placebo |
|
| GW642444M (25, 100 & 400 mcg) | Drug | M salt |
|
|
| London |
| SE1 1YR |
| United Kingdom |
| GSK Investigational Site | Manchester | M23 9QZ | United Kingdom |
| 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 |
For additional information about this study please refer to the GSK Clinical Study Register |
| B2C106996 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C106996 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C106996 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C106996 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C106996 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| B2C106996 | Annotated Case Report 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 |