A Study of GW685698X 100mcg Administered 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.
NCT ID: NCT01499446
Last Updated: 2016-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
669 participants
INTERVENTIONAL
2003-09-30
2004-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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GW685698X (fluticasone furoate) 100mcg Morning
GW685698X (fluticasone furoate) 100mcg Morning
GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
GW685698X (fluticasone furoate) 100mcg Evening
GW685698X (fluticasone furoate) 100mcg Evening
GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
GW685698X (fluticasone furoate) 250mcg Evening
GW685698X (fluticasone furoate) 250mcg Evening
GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
Placebo
GW685698X (fluticasone furoate) 100mcg Morning
GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
GW685698X (fluticasone furoate) 100mcg Evening
GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
GW685698X (fluticasone furoate) 250mcg Evening
GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
Placebo
Placebo inhaled twice daily (morning and evening) for 28 days
Interventions
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GW685698X (fluticasone furoate) 100mcg Morning
GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
GW685698X (fluticasone furoate) 100mcg Evening
GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
GW685698X (fluticasone furoate) 250mcg Evening
GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
Placebo
Placebo inhaled twice daily (morning and evening) for 28 days
Eligibility Criteria
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Inclusion Criteria
* Male and female; female subjects must be non-child bearing potential or of childbearing potenetial with negative pregnancy test and willing to use acceptable contraceptive methods
* Documented clinical history of persistent asthma first diagnosed at least 6 months prior to Visit 1
* Currently receiving inhaled short-acting beta-2 agonists for symptom relief
* A lung function of between 50 to 90% predicted (PEF)
* Increase in PEF of at least15%, 20 minutes after inhalation of 400mcg salbutamol
Exclusion Criteria
* History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures.
* A history of two or more asthma exacerbations requiring treatment with oral corticosteroids or hospitalisation in the 6 months before Visit 1.
* Past or present disease that, as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematologic disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis and bronchopulmonary dysplasia).
* Known or suspected sensitivity to corticosteroids, VENTOLIN, or the constituents of ROTADISKS (e.g., lactose).
* Undergoing allergen desensitisation therapy.
* Neurological or psychiatric disease or history of drug or alcohol abuse that would interfere with the subject's proper completion of the protocol requirements.
* Is a current smoker or has a smoking history of 10 pack years or more (e.g., 20 cigarettes/day for 10 years). Note: Current smoker is defined as currently smoking or stopped smoking within 6 months of screening visit.
16 Years
65 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
GSK Investigational Site
Pleven, , Bulgaria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Varna, , Bulgaria
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
Osijek, , Croatia
GSK Investigational Site
Split, , Croatia
GSK Investigational Site
Zagreb, , Croatia
GSK Investigational Site
Kohtal-Jdrve, , Estonia
GSK Investigational Site
Pärnu, , Estonia
GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Tartu, , Estonia
GSK Investigational Site
Schwetzingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Weinheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Eschwege, Hesse, Germany
GSK Investigational Site
Gelnhausen, Hesse, Germany
GSK Investigational Site
Kassel, Hesse, Germany
GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Lüneburg, Lower Saxony, Germany
GSK Investigational Site
Gütersloh, North Rhine-Westphalia, Germany
GSK Investigational Site
Annaberg, Saxony, Germany
GSK Investigational Site
Aue, Saxony, Germany
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Erfurt, Thuringia, Germany
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Papagos/Athens, , Greece
GSK Investigational Site
Törökbálint, , Hungary
GSK Investigational Site
Eboli (SA), Campania, Italy
GSK Investigational Site
Napoli, Campania, Italy
GSK Investigational Site
Salerno, Campania, Italy
GSK Investigational Site
Ferrara, Emilia-Romagna, Italy
GSK Investigational Site
Genoa, Liguria, Italy
GSK Investigational Site
Sesto San Giovanni (MI), Lombardy, Italy
GSK Investigational Site
Torrette (AN), The Marches, Italy
GSK Investigational Site
Florence, Tuscany, Italy
GSK Investigational Site
Pisa, Tuscany, Italy
GSK Investigational Site
Bussolengo (VR), Veneto, Italy
GSK Investigational Site
Padua, Veneto, Italy
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
México, , Mexico
GSK Investigational Site
Brasov, , Romania
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Kazan', , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Tomsk, , Russia
GSK Investigational Site
Volgograd, , Russia
GSK Investigational Site
Bloemfontein, , South Africa
GSK Investigational Site
Cape Town, , South Africa
Countries
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References
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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.
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.
Study Documents
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Document Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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FFA20001
Identifier Type: -
Identifier Source: org_study_id
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