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Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents

18. november 2016 opdateret af: GlaxoSmithKline

A Randomised, Double-blind, Multi-centre Study to Evaluate the Efficacy and Safety of Inhaled Fluticasone Furoate in the Treatment of Persistent Asthma in Adults and Adolescents Currently Receiving Mid to High Strength Inhaled Corticosteroids.

A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This will be a multi-centre, randomised, double-blind, parallel-group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (screening visit) will enter a four week Run-In period during which they will remain on their baseline ICS medication. In addition, all subjects will be provided with albuterol/salbutamol for relief of asthma symptoms. Subjects failing screening will not be eligible for re-screening. During the Run-In and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening Peak Expiratory Flow (PEF), asthma symptom score and rescue albuterol/salbutamol use. Subjects will receive a contact (Phone Contact 1/optional office visit (1b)) during Run-In to reinforce compliance with Run-In medication and diary monitoring. Those subjects who meet the eligibility criteria at the end of the Run-In period will be stratified in an approximately 1:1 ratio according to their baseline FEV1 as a percentage of predicted normal - one stratum for those with FEV1 percent predicted ≥40% to ≤65% and one for those with FEV1 percent predicted >65% to ≤90%. Once stratified, subjects will be randomised to one of the following treatments and enter into a 24 week double-blind treatment period:1) Fluticasone furoate 100mcg once daily in the evening or 2) Fluticasone furoate 200mcg once daily in the evening.

Subjects will then attend 6 on-treatment visits at Visits 3, 4, 5, 6, 7 and 8 (Weeks 2, 4, 8, 12, 18 and 24 respectively). All visits including Visit 1 must be conducted in the evening between 5 PM and 11 PM. Subjects will receive treatment for 24 weeks. Twenty four hour urinary cortisol assessments will be collected at the end of Run-In (Visit 2) and at end of treatment (Visit 8) visits. A follow-up contact will be performed 1-week after completing study medication (Visit 9). Subjects will participate in the study for up to a maximum of 29 weeks (including screening, treatment and follow-up contact). In addition, partially used NDPIs will be collected in a subset of subjects. For subjects who have consented for pharmacogenetics, a blood sample will also be taken for pharmacogenetic analysis.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

238

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C1425BEN
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
        • GSK Investigational Site
      • Mendoza, Argentina, M5500CCG
        • GSK Investigational Site
      • San Miguel de Tucumán, Argentina, 4000
        • GSK Investigational Site
  • Chile
    • Región Metro De Santiago
      • Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7500800
        • GSK Investigational Site
    • Valparaíso
      • Valparaiso, Valparaíso, Chile, 2341131
        • GSK Investigational Site
  • Den Russiske Føderation
      • Belgorod, Den Russiske Føderation, 308007
        • GSK Investigational Site
      • Kazan, Den Russiske Føderation, 420015
        • GSK Investigational Site
      • Novokuznetsk, Den Russiske Føderation, 654063
        • GSK Investigational Site
      • Penza, Den Russiske Føderation, 440067
        • GSK Investigational Site
      • Pyatigorsk, Den Russiske Føderation, 357538
        • GSK Investigational Site
  • Forenede Stater
    • California
      • Long Beach, California, Forenede Stater, 90808
        • GSK Investigational Site
      • Newport Beach, California, Forenede Stater, 92663
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • GSK Investigational Site
    • Florida
      • Clearwater, Florida, Forenede Stater, 33756
        • GSK Investigational Site
    • Georgia
      • Albany, Georgia, Forenede Stater, 31707
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503
        • GSK Investigational Site
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70006
        • GSK Investigational Site
      • Sunset, Louisiana, Forenede Stater, 70584
        • GSK Investigational Site
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20814
        • GSK Investigational Site
    • Minnesota
      • Plymouth, Minnesota, Forenede Stater, 55441
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • GSK Investigational Site
    • New Jersey
      • Brick, New Jersey, Forenede Stater, 08724
        • GSK Investigational Site
    • New York
      • Utica, New York, Forenede Stater, 13502
        • GSK Investigational Site
    • Ohio
      • Canton, Ohio, Forenede Stater, 44718
        • GSK Investigational Site
      • Cincinnati, Ohio, Forenede Stater, 45242
        • GSK Investigational Site
      • Toledo, Ohio, Forenede Stater, 43617
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • GSK Investigational Site
    • South Carolina
      • Orangeburg, South Carolina, Forenede Stater, 29118
        • GSK Investigational Site
    • Texas
      • Corsicana, Texas, Forenede Stater, 75110
        • GSK Investigational Site
  • Frankrig
      • Aigrefeuille Sur Maine, Frankrig, 44140
        • GSK Investigational Site
      • Bourg Des Comptes, Frankrig, 35890
        • GSK Investigational Site
      • Chalons en Champagne, Frankrig, 51000
        • GSK Investigational Site
      • Laon, Frankrig, 02000
        • GSK Investigational Site
      • Nantes, Frankrig, 44300
        • GSK Investigational Site
      • Vannes, Frankrig, 56000
        • GSK Investigational Site
  • Mexico
      • Mexico City, Mexico, 07760
        • GSK Investigational Site
    • Tabasco
      • Villahermosa, Tabasco, Mexico, 86100
        • 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

12 år til 100 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Signed informed consent
  • Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks prior to first visit
  • Both genders; females of child bearing potential must be willing to use appropriate contraception
  • Pre-bronchodilator FEV1 of 40-90% predicted
  • Reversibility FEV1 of at least 12% and 200mLs
  • Current asthma therapy that includes inhaled corticosteroid for at least 4 weeks prior to first visit

Exclusion Criteria:

  • History of life threatening asthma
  • Respiratory infection or candidiasis
  • Asthma exacerbation requiring OCS within last 4 weeks or overnight hospital stay within the last 3 months
  • Concurrent respiratory disease or other disease that would confound study participation of affect subject safety
  • Allergies to study drugs, study drug excipients, medications related to study drugs
  • Taking another investigational medication or medication prohibited for use during the study
  • Previous treatment with FF or FF/VI in a phase II or III study
  • Night shift workers
  • Children in care

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: FF 100mcg once daily
Inhaled corticosteroid (ICS)
Medicin: fluticasone furoate
Inhaled corticosteroid
Medicin: albuterol/salbutamol
Provided as rescue relief of asthma symptoms
Eksperimentel: FF 200mcg once daily
Inhaled corticosteroid
Medicin: fluticasone furoate
Inhaled corticosteroid
Medicin: albuterol/salbutamol
Provided as rescue relief of asthma symptoms

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period
Tidsramme: Baseline and Week 24
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.
Baseline and Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring fra baseline i procentdelen af ​​redningsfrie 24-timers (timers) perioder i løbet af den 24-ugers behandlingsperiode
Tidsramme: Fra baseline op til uge 24
Antallet af inhalationer af redningsbronkodilatator, albuterol/salbutamol inhalationsaerosol, anvendt i løbet af dagen og natten blev registreret af deltagerne i en daglig elektronisk dagbog (eDiary). En 24-timers periode, hvor en deltagers svar på både morgen- og aftenvurderinger indikerede, at ingen brug af redningsmedicin blev anset for at være redningsfri. En 24-timers periode blev anset for at mangle, hvis både dag- og natværdier manglede, eller hvis en af ​​dag- eller natværdierne manglede, og den anden værdi indikerede ingen brug af redningsmedicin. Baseline-værdien er gennemsnittet af værdierne over de sidste 7 dage af den daglige e-dagbog forud for randomiseringen af ​​deltageren. Ændring fra baseline blev beregnet som den gennemsnitlige værdi i løbet af den 24-ugers behandlingsperiode minus baseline-værdien. Analyse blev udført ved anvendelse af ANCOVA med kovariater af baseline, region, køn, alder og behandling.
Fra baseline op til uge 24
Ændring fra baseline i daglig aften (PM) Peak Expiratory Flow (PEF) i gennemsnit over den 24-ugers behandlingsperiode
Tidsramme: Fra baseline op til uge 24
PEF er et mål for lungefunktionen og er defineret som den maksimale luftstrøm under en tvungen ekspiration, der begynder med lungerne helt oppustede. PEF blev målt af deltagerne ved hjælp af en håndholdt elektronisk peak flowmåler hver morgen og aften forud for dosis af undersøgelsesmedicin og enhver brug af albuterol/salbutamol inhalationsaerosol. Ændring fra baseline (defineret som gennemsnittet af værdierne for de sidste 7 dage forud for randomisering af deltagerne) blev beregnet som værdien af ​​den gennemsnitlige daglige laveste PM PEF over den 24-ugers behandlingsperiode minus baselineværdien. Analyse blev udført ved anvendelse af ANCOVA med kovariater af baseline, region, køn, alder og behandling.
Fra baseline op til uge 24
Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period
Tidsramme: From Baseline up to Week 24
PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
From Baseline up to Week 24
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 24-week Treatment Period
Tidsramme: From Baseline up to Week 24
Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
From Baseline up to Week 24

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 2011

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først indsendt

25. august 2011

Først indsendt, der opfyldte QC-kriterier

8. september 2011

Først opslået (Skøn)

12. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 114496

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: 114496
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistisk analyseplan
    Informations-id: 114496
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formular til informeret samtykke
    Informations-id: 114496
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individuelt deltagerdatasæt
    Informations-id: 114496
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Klinisk undersøgelsesrapport
    Informations-id: 114496
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Datasætspecifikation
    Informations-id: 114496
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Studieprotokol
    Informations-id: 114496
    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 .

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