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Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma

9. oktober 2017 opdateret af: GlaxoSmithKline

A Randomized, Double-blind, Double-dummy, Parallel-group, Placebo Controlled (on Inhaled Corticosteroid Medication), Multicenter Study to Evaluate the Efficacy and Safety of Vilanterol Inhalation Powder (GW642444) and Salmeterol, Compared With Placebo in the Treatment of Persistent Asthma in Adults and Adolescents Uncontrolled on Inhaled Corticosteroids

The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

348

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Huntington Beach, California, Forenede Stater, 92647
        • GSK Investigational Site
    • Florida
      • Orlando, Florida, Forenede Stater, 32822
        • GSK Investigational Site
      • Tallahassee, Florida, Forenede Stater, 32308
        • GSK Investigational Site
    • Georgia
      • Lawrenceville, Georgia, Forenede Stater, 30046
        • GSK Investigational Site
    • New Jersey
      • Skillman, New Jersey, Forenede Stater, 08558
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27607
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45231
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • GSK Investigational Site
    • South Carolina
      • Chester, South Carolina, Forenede Stater, 29706
        • GSK Investigational Site
      • Clinton, South Carolina, Forenede Stater, 29325
        • GSK Investigational Site
      • Orangeburg, South Carolina, Forenede Stater, 29118
        • GSK Investigational Site
  • Peru
      • Lima, Peru, Lima 27
        • GSK Investigational Site
    • Lima
      • Callao, Lima, Peru, Callao 2
        • GSK Investigational Site
      • Lima 27, Lima, Peru, Lima 27
        • GSK Investigational Site
      • San Isidro, Lima, Peru, Lima 27
        • GSK Investigational Site
      • San Miguel, Lima, Peru, Lima 32
        • GSK Investigational Site
  • Polen
      • Chrzanow, Polen, 32-500
        • GSK Investigational Site
      • Krakow, Polen, 31-024
        • GSK Investigational Site
      • Krakow, Polen, 31-455
        • GSK Investigational Site
      • Krakow, Polen, 30-901
        • GSK Investigational Site
      • Lublin, Polen, 20-552
        • GSK Investigational Site
  • Tyskland
    • Bayern
      • Gauting, Bayern, Tyskland, 82131
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Tyskland, 60596
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Tyskland, 55131
        • GSK Investigational Site
    • Schleswig-Holstein
      • Grosshansdorf, Schleswig-Holstein, Tyskland, 22927
        • GSK Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49074
        • GSK Investigational Site
      • Dnipropetrovsk, Ukraine, 49027
        • GSK Investigational Site
      • Donetsk, Ukraine, 83099
        • GSK Investigational Site
      • Ivano-Frankivsk, Ukraine, 76018
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61124
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61037
        • GSK Investigational Site
      • Kyiv, Ukraine, 03680
        • GSK Investigational Site
      • Simferopol, Ukraine, 95043
        • GSK Investigational Site
      • Yalta, Ukraine, 98603
        • 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 og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Outpatient at least 12 years of age
  • Both genders; females of childbearing potential must be willing to use birth control method
  • Clinical diagnosis of asthma for ≥12 weeks
  • Best pre-bronchodilator FEV1 of 40%-90% predicted
  • Reversibility of FEV1 of at least 12% and 200mls
  • Current asthma therapy that include an inhaled corticosteroid for at least 12 weeks prior to 1st visit
  • Ability to use replace current short-acting rescue treatment with albuterol and ability to withhold albuterol use for at least 6 hours prior to study visits

Exclusion Criteria:

  • History of life-threatening asthma
  • Respiratory infection within last 4 weeks leading to change in asthma management
  • Asthma exacerbation within last 3 months
  • Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
  • Allergies to study drugs, study drugs' excipients, or medications related to study drugs
  • Taking another investigational medication or medication prohibited for use during the study.
  • Previous participation in a vilanterol (GW642444) study

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Vilanterol
Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
Medicin: Vilanterol
Vilanterol inhalation powder inhaled orally once daily for 12 weeks
Medicin: Placebo Inhalation Powder Diskus
Placebo inhalation powder inhaled orally twice daily for 12 weeks
Aktiv komparator: Salmeterol
Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks
Medicin: Salmeterol Inhalation Powder
Salmeterol inhalation powder inhaled orally twice daily for 12 weeks
Medicin: Placebo Inhalation Powder NDPI
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
Placebo komparator: Placebo
Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
Medicin: Placebo Inhalation Powder Diskus
Placebo inhalation powder inhaled orally twice daily for 12 weeks
Medicin: Placebo Inhalation Powder NDPI
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12
Tidsramme: Baseline and Week 12
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.
Baseline and Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period
Tidsramme: Baseline and Weeks 1-12
The time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Baseline and Weeks 1-12
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period
Tidsramme: Baseline and Weeks 1-12
Participants who were symptom free for 24-hour periods during the12-week treatment period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Baseline and Weeks 1-12
Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
Tidsramme: Baseline and Week 12
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12). The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment. Analysis was performed separately for each planned time point.
Baseline and Week 12
Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) PM (Evening) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period
Tidsramme: Baseline and Weeks 1-12
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization. Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Baseline and Weeks 1-12
Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period
Tidsramme: Baseline and Weeks 1-12
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization. Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Baseline and Weeks 1-12
Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Tidsramme: Day 1 and Week 12
The number of participants with a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a >=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points. Participants who did not achieve a >=12% and >=200 mL increase from Baseline in FEV1 over this time period were considered censored.
Day 1 and Week 12
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Tidsramme: Week 4 and Week 12
At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often.
Week 4 and Week 12

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 2010

Primær færdiggørelse (Faktiske)

1. august 2011

Studieafslutning (Faktiske)

26. august 2011

Datoer for studieregistrering

Først indsendt

15. juli 2010

Først indsendt, der opfyldte QC-kriterier

12. august 2010

Først opslået (Skøn)

13. august 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 112060

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. Klinisk undersøgelsesrapport
    Informations-id: 112060
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annoteret sagsbetænkningsformular
    Informations-id: 112060
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formular til informeret samtykke
    Informations-id: 112060
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistisk analyseplan
    Informations-id: 112060
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individuelt deltagerdatasæt
    Informations-id: 112060
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Studieprotokol
    Informations-id: 112060
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Datasætspecifikation
    Informations-id: 112060
    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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