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The purpose of this study is to compare the efficacy and safety of GW685698X 100mcg once daily either in the morning or the evening and GW685698X 250mcg administered once daily in the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW685698X (fluticasone furoate) 100mcg Morning | Experimental |
| |
| GW685698X (fluticasone furoate) 100mcg Evening | Experimental |
| |
| GW685698X (fluticasone furoate) 250mcg Evening | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW685698X (fluticasone furoate) 100mcg Morning | Drug | GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak expiratory flow (PEF) | Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning compared with GW685698X 100mcg once daily in the evening by inhalation via DISKHALER. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak expiratory flow (PEF) | Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 250mcg once daily compared with GW685698X 100mcg once daily both administered in the evening by inhalation via DISKHALER. | 28 days |
| PEF |
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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 | Porto Alegre | Rio Grande do Sul | 40110-160 | Brazil | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27881132 | Derived | O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x. | |
| 22796247 | Derived | Medley H, Orozco S, Allen A. Efficacy and safety profile of fluticasone furoate administered once daily in the morning or evening: a randomized, double-blind, double-dummy, placebo-controlled trial in adult and adolescent patients with persistent bronchial asthma. Clin Ther. 2012 Aug;34(8):1683-95. doi: 10.1016/j.clinthera.2012.06.024. Epub 2012 Jul 13. |
| 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 |
|---|---|---|---|
| FFA20001 | 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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| GW685698X (fluticasone furoate) 100mcg Evening | Drug | GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days |
|
| GW685698X (fluticasone furoate) 250mcg Evening | Drug | GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days |
|
| Placebo | Drug | Placebo inhaled twice daily (morning and evening) for 28 days |
|
Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning, 100mcg once daily in the evening, or GW685698X 250mcg once daily in the evening, compared with placebo |
| 28 days |
| Clinic lung function | Change from baseline in pre bronchodilator clinic lung function (forced expiratory volume in 1 second [FEV1] and PEF) after 28 days of treatment with GW685698X 250mcg once daily in the evening compared with GW685698X 100mcg once daily in the evening | 28 days |
| Pleven |
| 5800 |
| Bulgaria |
| GSK Investigational Site | Sofia | 1431/1000 | Bulgaria |
| GSK Investigational Site | Sofia | 1606 | Bulgaria |
| GSK Investigational Site | Sofia | 1619 | Bulgaria |
| GSK Investigational Site | Varna | 9010 | Bulgaria |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 7500551 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 7500691 | Chile |
| GSK Investigational Site | Osijek | 31000 | Croatia |
| GSK Investigational Site | Split | 21000 | Croatia |
| GSK Investigational Site | Zagreb | 10000 | Croatia |
| GSK Investigational Site | Kohtal-Jdrve | 31 025 | Estonia |
| GSK Investigational Site | Pärnu | 80024 | Estonia |
| GSK Investigational Site | Tallinn | 1162 | Estonia |
| GSK Investigational Site | Tartu | 51014 | Estonia |
| GSK Investigational Site | Schwetzingen | Baden-Wurttemberg | 68723 | Germany |
| GSK Investigational Site | Weinheim | Baden-Wurttemberg | 69469 | Germany |
| GSK Investigational Site | Eschwege | Hesse | 37269 | Germany |
| GSK Investigational Site | Gelnhausen | Hesse | 63571 | Germany |
| GSK Investigational Site | Kassel | Hesse | 34117 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30159 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30167 | Germany |
| GSK Investigational Site | Lüneburg | Lower Saxony | 21335 | Germany |
| GSK Investigational Site | Gütersloh | North Rhine-Westphalia | 33330 | Germany |
| GSK Investigational Site | Annaberg | Saxony | 09456 | Germany |
| GSK Investigational Site | Aue | Saxony | 08280 | Germany |
| GSK Investigational Site | Geesthacht | Schleswig-Holstein | 21502 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10365 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10585 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10717 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10969 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13086 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13597 | Germany |
| GSK Investigational Site | Erfurt | Thuringia | 99084 | Germany |
| GSK Investigational Site | Athens | 115 28 | Greece |
| GSK Investigational Site | Athens | 15669 | Greece |
| GSK Investigational Site | Papagos/Athens | 15669 | Greece |
| GSK Investigational Site | Törökbálint | 2045 | Hungary |
| GSK Investigational Site | Eboli (SA) | Campania | 84025 | Italy |
| GSK Investigational Site | Naples | Campania | 80131 | Italy |
| GSK Investigational Site | Salerno | Campania | 84126 | Italy |
| GSK Investigational Site | Ferrara | Emilia-Romagna | 44100 | Italy |
| GSK Investigational Site | Genoa | Liguria | 16132 | Italy |
| GSK Investigational Site | Sesto San Giovanni (MI) | Lombardy | 20099 | Italy |
| GSK Investigational Site | Torrette (AN) | The Marches | 60126 | Italy |
| GSK Investigational Site | Florence | Tuscany | 50134 | Italy |
| GSK Investigational Site | Pisa | Tuscany | 56124 | Italy |
| GSK Investigational Site | Bussolengo (VR) | Veneto | 37012 | Italy |
| GSK Investigational Site | Padova | Veneto | 35128 | Italy |
| GSK Investigational Site | Mexico City | 06720 | Mexico |
| GSK Investigational Site | México | 04530 | Mexico |
| GSK Investigational Site | Brasov | Romania |
| GSK Investigational Site | Bucharest | 050159 | Romania |
| GSK Investigational Site | Bucharest | 70000 | Romania |
| GSK Investigational Site | Kazan' | 420015 | Russia |
| GSK Investigational Site | Moscow | 115446 | Russia |
| GSK Investigational Site | Moscow | 115478 | Russia |
| GSK Investigational Site | Moscow | 123 182 | Russia |
| GSK Investigational Site | Saint Petersburg | 197 089 | Russia |
| GSK Investigational Site | Saint Petersburg | 197022 | Russia |
| GSK Investigational Site | Tomsk | 634 050 | Russia |
| GSK Investigational Site | Volgograd | 400130 | Russia |
| GSK Investigational Site | Bloemfontein | 9300 | South Africa |
| GSK Investigational Site | Cape Town | 7500 | South Africa |
For additional information about this study please refer to the GSK Clinical Study Register |
| FFA20001 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFA20001 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFA20001 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFA20001 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFA20001 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFA20001 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 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 |
|---|---|
| C523187 | fluticasone furoate |
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