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.
13 september 2016 uppdaterad av: GlaxoSmithKline
A Randomised, Double-blind, Double Dummy, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening All Administered by Inhalation Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.
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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
669
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasilien, 40110-160
- GSK Investigational Site
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Pleven, Bulgarien, 5800
- GSK Investigational Site
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Sofia, Bulgarien, 1606
- GSK Investigational Site
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Sofia, Bulgarien, 1431/1000
- GSK Investigational Site
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Sofia, Bulgarien, 1619
- GSK Investigational Site
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Varna, Bulgarien, 9010
- GSK Investigational Site
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Región Metro De Santiago
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Santiago, Región Metro De Santiago, Chile, 7500551
- GSK Investigational Site
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Santiago, Región Metro De Santiago, Chile, 7500691
- GSK Investigational Site
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Kohtal-Jdrve, Estland, 31 025
- GSK Investigational Site
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Parnu, Estland, 80024
- GSK Investigational Site
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Tallinn, Estland, 1162
- GSK Investigational Site
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Tartu, Estland, 51014
- GSK Investigational Site
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Athens, Grekland, 115 28
- GSK Investigational Site
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Athens, Grekland, 15669
- GSK Investigational Site
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Papagos/Athens, Grekland, 15669
- GSK Investigational Site
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Campania
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Eboli (SA), Campania, Italien, 84025
- GSK Investigational Site
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Napoli, Campania, Italien, 80131
- GSK Investigational Site
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Salerno, Campania, Italien, 84126
- GSK Investigational Site
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Emilia-Romagna
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Ferrara, Emilia-Romagna, Italien, 44100
- GSK Investigational Site
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Liguria
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Genova, Liguria, Italien, 16132
- GSK Investigational Site
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Lombardia
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Sesto San Giovanni (MI), Lombardia, Italien, 20099
- GSK Investigational Site
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Marche
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Torrette (AN), Marche, Italien, 60126
- GSK Investigational Site
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Toscana
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Firenze, Toscana, Italien, 50134
- GSK Investigational Site
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Pisa, Toscana, Italien, 56124
- GSK Investigational Site
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Veneto
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Bussolengo (VR), Veneto, Italien, 37012
- GSK Investigational Site
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Padova, Veneto, Italien, 35128
- GSK Investigational Site
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Osijek, Kroatien, 31000
- GSK Investigational Site
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Split, Kroatien, 21000
- GSK Investigational Site
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Zagreb, Kroatien, 10000
- GSK Investigational Site
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Mexico, Mexiko, 04530
- GSK Investigational Site
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Mexico, D.F., Mexiko, 06720
- GSK Investigational Site
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Brasov, Rumänien
- GSK Investigational Site
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Bucharest, Rumänien, 050159
- GSK Investigational Site
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Bucuresti, Rumänien, 70000
- GSK Investigational Site
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Kazan, Ryska Federationen, 420015
- GSK Investigational Site
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Moscow, Ryska Federationen, 115446
- GSK Investigational Site
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Moscow, Ryska Federationen, 115478
- GSK Investigational Site
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Moscow, Ryska Federationen, 123 182
- GSK Investigational Site
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St. Petersburg, Ryska Federationen, 197022
- GSK Investigational Site
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St. Petersburg, Ryska Federationen, 197 089
- GSK Investigational Site
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Tomsk, Ryska Federationen, 634 050
- GSK Investigational Site
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Volgograd, Ryska Federationen, 400130
- GSK Investigational Site
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Bloemfontein, Sydafrika, 9300
- GSK Investigational Site
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Cape Town, Sydafrika, 7500
- GSK Investigational Site
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Berlin, Tyskland, 13086
- GSK Investigational Site
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Berlin, Tyskland, 10717
- GSK Investigational Site
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Berlin, Tyskland, 13597
- GSK Investigational Site
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Berlin, Tyskland, 10969
- GSK Investigational Site
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Berlin, Tyskland, 10365
- GSK Investigational Site
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Berlin, Tyskland, 10585
- GSK Investigational Site
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Baden-Wuerttemberg
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Schwetzingen, Baden-Wuerttemberg, Tyskland, 68723
- GSK Investigational Site
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Weinheim, Baden-Wuerttemberg, Tyskland, 69469
- GSK Investigational Site
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Hessen
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Eschwege, Hessen, Tyskland, 37269
- GSK Investigational Site
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Gelnhausen, Hessen, Tyskland, 63571
- GSK Investigational Site
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Kassel, Hessen, Tyskland, 34117
- GSK Investigational Site
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Niedersachsen
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Hannover, Niedersachsen, Tyskland, 30159
- GSK Investigational Site
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Hannover, Niedersachsen, Tyskland, 30167
- GSK Investigational Site
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Lueneburg, Niedersachsen, Tyskland, 21335
- GSK Investigational Site
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Nordrhein-Westfalen
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Guetersloh, Nordrhein-Westfalen, Tyskland, 33330
- GSK Investigational Site
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Sachsen
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Annaberg, Sachsen, Tyskland, 09456
- GSK Investigational Site
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Aue, Sachsen, Tyskland, 08280
- GSK Investigational Site
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Schleswig-Holstein
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Geesthacht, Schleswig-Holstein, Tyskland, 21502
- GSK Investigational Site
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Thueringen
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Erfurt, Thueringen, Tyskland, 99084
- GSK Investigational Site
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Törökbálint, Ungern, 2045
- GSK Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
16 år till 65 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Outpatients aged between 16- 65 years.
- 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 respiratory tract infection and/or exacerbation of asthma within a period of 4 weeks prior to Visit 1
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: Placebo
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GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
Placebo inhaled twice daily (morning and evening) for 28 days
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Experimentell: GW685698X (fluticasone furoate) 100mcg Morning
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GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
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Experimentell: GW685698X (fluticasone furoate) 100mcg Evening
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GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
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Experimentell: GW685698X (fluticasone furoate) 250mcg Evening
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GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Peak expiratory flow (PEF)
Tidsram: 28 days
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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.
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28 days
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Peak expiratory flow (PEF)
Tidsram: 28 days
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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.
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28 days
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PEF
Tidsram: 28 days
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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
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28 days
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Clinic lung function
Tidsram: 28 days
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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
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28 days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2003
Primärt slutförande (Faktisk)
1 mars 2004
Avslutad studie (Faktisk)
1 mars 2004
Studieregistreringsdatum
Först inskickad
8 december 2011
Först inskickad som uppfyllde QC-kriterierna
21 december 2011
Första postat (Uppskatta)
26 december 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
15 september 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 september 2016
Senast verifierad
1 september 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Immunsystemets sjukdomar
- Lungsjukdomar
- Överkänslighet, Omedelbar
- Bronkialsjukdomar
- Lungsjukdomar, obstruktiv
- Respiratorisk överkänslighet
- Överkänslighet
- Astma
- Läkemedels fysiologiska effekter
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Antiinflammatoriska medel
- Dermatologiska medel
- Bronkdilaterande medel
- Anti-astmatiska medel
- Andningsorgan
- Anti-allergiska medel
- Flutikason
- Xhance
Andra studie-ID-nummer
- FFA20001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokument
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Annoterad fallrapportformulär
Informationsidentifierare: FFA20001Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättningsspecifikation
Informationsidentifierare: FFA20001Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analysplan
Informationsidentifierare: FFA20001Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Informerat samtycke
Informationsidentifierare: FFA20001Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informationsidentifierare: FFA20001Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättning för individuella deltagare
Informationsidentifierare: FFA20001Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informationsidentifierare: FFA20001Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .