Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

669

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brasilien, 40110-160
        • GSK Investigational Site
  • Bulgarien
      • Pleven, Bulgarien, 5800
        • GSK Investigational Site
      • Sofia, Bulgarien, 1606
        • GSK Investigational Site
      • Sofia, Bulgarien, 1431/1000
        • GSK Investigational Site
      • Sofia, Bulgarien, 1619
        • GSK Investigational Site
      • Varna, Bulgarien, 9010
        • GSK Investigational Site
  • Chile
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 7500551
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7500691
        • GSK Investigational Site
  • Den Russiske Føderation
      • Kazan, Den Russiske Føderation, 420015
        • GSK Investigational Site
      • Moscow, Den Russiske Føderation, 115446
        • GSK Investigational Site
      • Moscow, Den Russiske Føderation, 115478
        • GSK Investigational Site
      • Moscow, Den Russiske Føderation, 123 182
        • GSK Investigational Site
      • St. Petersburg, Den Russiske Føderation, 197022
        • GSK Investigational Site
      • St. Petersburg, Den Russiske Føderation, 197 089
        • GSK Investigational Site
      • Tomsk, Den Russiske Føderation, 634 050
        • GSK Investigational Site
      • Volgograd, Den Russiske Føderation, 400130
        • GSK Investigational Site
  • Estland
      • Kohtal-Jdrve, Estland, 31 025
        • GSK Investigational Site
      • Parnu, Estland, 80024
        • GSK Investigational Site
      • Tallinn, Estland, 1162
        • GSK Investigational Site
      • Tartu, Estland, 51014
        • GSK Investigational Site
  • Grækenland
      • Athens, Grækenland, 115 28
        • GSK Investigational Site
      • Athens, Grækenland, 15669
        • GSK Investigational Site
      • Papagos/Athens, Grækenland, 15669
        • GSK Investigational Site
  • Italien
    • Campania
      • Eboli (SA), Campania, Italien, 84025
        • GSK Investigational Site
      • Napoli, Campania, Italien, 80131
        • GSK Investigational Site
      • Salerno, Campania, Italien, 84126
        • GSK Investigational Site
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italien, 44100
        • GSK Investigational Site
    • Liguria
      • Genova, Liguria, Italien, 16132
        • GSK Investigational Site
    • Lombardia
      • Sesto San Giovanni (MI), Lombardia, Italien, 20099
        • GSK Investigational Site
    • Marche
      • Torrette (AN), Marche, Italien, 60126
        • GSK Investigational Site
    • Toscana
      • Firenze, Toscana, Italien, 50134
        • GSK Investigational Site
      • Pisa, Toscana, Italien, 56124
        • GSK Investigational Site
    • Veneto
      • Bussolengo (VR), Veneto, Italien, 37012
        • GSK Investigational Site
      • Padova, Veneto, Italien, 35128
        • GSK Investigational Site
  • Kroatien
      • Osijek, Kroatien, 31000
        • GSK Investigational Site
      • Split, Kroatien, 21000
        • GSK Investigational Site
      • Zagreb, Kroatien, 10000
        • GSK Investigational Site
  • Mexico
      • Mexico, Mexico, 04530
        • GSK Investigational Site
      • Mexico, D.F., Mexico, 06720
        • GSK Investigational Site
  • Rumænien
      • Brasov, Rumænien
        • GSK Investigational Site
      • Bucharest, Rumænien, 050159
        • GSK Investigational Site
      • Bucuresti, Rumænien, 70000
        • GSK Investigational Site
  • Sydafrika
      • Bloemfontein, Sydafrika, 9300
        • GSK Investigational Site
      • Cape Town, Sydafrika, 7500
        • GSK Investigational Site
  • Tyskland
      • Berlin, Tyskland, 13086
        • GSK Investigational Site
      • Berlin, Tyskland, 10717
        • GSK Investigational Site
      • Berlin, Tyskland, 13597
        • GSK Investigational Site
      • Berlin, Tyskland, 10969
        • GSK Investigational Site
      • Berlin, Tyskland, 10365
        • GSK Investigational Site
      • Berlin, Tyskland, 10585
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Schwetzingen, Baden-Wuerttemberg, Tyskland, 68723
        • GSK Investigational Site
      • Weinheim, Baden-Wuerttemberg, Tyskland, 69469
        • GSK Investigational Site
    • Hessen
      • Eschwege, Hessen, Tyskland, 37269
        • GSK Investigational Site
      • Gelnhausen, Hessen, Tyskland, 63571
        • GSK Investigational Site
      • Kassel, Hessen, Tyskland, 34117
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Tyskland, 30159
        • GSK Investigational Site
      • Hannover, Niedersachsen, Tyskland, 30167
        • GSK Investigational Site
      • Lueneburg, Niedersachsen, Tyskland, 21335
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Guetersloh, Nordrhein-Westfalen, Tyskland, 33330
        • GSK Investigational Site
    • Sachsen
      • Annaberg, Sachsen, Tyskland, 09456
        • GSK Investigational Site
      • Aue, Sachsen, Tyskland, 08280
        • GSK Investigational Site
    • Schleswig-Holstein
      • Geesthacht, Schleswig-Holstein, Tyskland, 21502
        • GSK Investigational Site
    • Thueringen
      • Erfurt, Thueringen, Tyskland, 99084
        • GSK Investigational Site
  • Ungarn
      • Törökbálint, Ungarn, 2045
        • GSK Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år til 65 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: GW685698X (fluticasone furoate) 100mcg Morning
GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
Medicin: GW685698X (fluticasone furoate) 100mcg Evening
GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
Medicin: GW685698X (fluticasone furoate) 250mcg Evening
GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
Medicin: Placebo
Placebo inhaled twice daily (morning and evening) for 28 days
Eksperimentel: GW685698X (fluticasone furoate) 100mcg Morning
Medicin: GW685698X (fluticasone furoate) 100mcg Morning
GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
Eksperimentel: GW685698X (fluticasone furoate) 100mcg Evening
Medicin: GW685698X (fluticasone furoate) 100mcg Evening
GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
Eksperimentel: GW685698X (fluticasone furoate) 250mcg Evening
Medicin: GW685698X (fluticasone furoate) 250mcg Evening
GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak expiratory flow (PEF)
Tidsramme: 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 compared with GW685698X 100mcg once daily in the evening by inhalation via DISKHALER.
28 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak expiratory flow (PEF)
Tidsramme: 28 days
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
Tidsramme: 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
Tidsramme: 28 days
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2003

Primær færdiggørelse (Faktiske)

1. marts 2004

Studieafslutning (Faktiske)

1. marts 2004

Datoer for studieregistrering

Først indsendt

8. december 2011

Først indsendt, der opfyldte QC-kriterier

21. december 2011

Først opslået (Skøn)

26. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. september 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. september 2016

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FFA20001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokumenter

  1. Annoteret sagsbetænkningsformular
    Informations-id: FFA20001
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Datasætspecifikation
    Informations-id: FFA20001
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistisk analyseplan
    Informations-id: FFA20001
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Formular til informeret samtykke
    Informations-id: FFA20001
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Klinisk undersøgelsesrapport
    Informations-id: FFA20001
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individuelt deltagerdatasæt
    Informations-id: FFA20001
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Studieprotokol
    Informations-id: FFA20001
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med GW685698X (fluticasone furoate) 100mcg Morning

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Papua New Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner