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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 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

348

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Deutschland
    • Bayern
      • Gauting, Bayern, Deutschland, 82131
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Deutschland, 60596
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Deutschland, 55131
        • GSK Investigational Site
    • Schleswig-Holstein
      • Grosshansdorf, Schleswig-Holstein, Deutschland, 22927
        • 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
  • 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
  • Vereinigte Staaten
    • California
      • Huntington Beach, California, Vereinigte Staaten, 92647
        • GSK Investigational Site
    • Florida
      • Orlando, Florida, Vereinigte Staaten, 32822
        • GSK Investigational Site
      • Tallahassee, Florida, Vereinigte Staaten, 32308
        • GSK Investigational Site
    • Georgia
      • Lawrenceville, Georgia, Vereinigte Staaten, 30046
        • GSK Investigational Site
    • New Jersey
      • Skillman, New Jersey, Vereinigte Staaten, 08558
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, Vereinigte Staaten, 27607
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, Vereinigte Staaten, 45231
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73103
        • GSK Investigational Site
    • South Carolina
      • Chester, South Carolina, Vereinigte Staaten, 29706
        • GSK Investigational Site
      • Clinton, South Carolina, Vereinigte Staaten, 29325
        • GSK Investigational Site
      • Orangeburg, South Carolina, Vereinigte Staaten, 29118
        • GSK Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Vilanterol
Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
Arzneimittel: Vilanterol
Vilanterol inhalation powder inhaled orally once daily for 12 weeks
Arzneimittel: Placebo Inhalation Powder Diskus
Placebo inhalation powder inhaled orally twice daily for 12 weeks
Aktiver Komparator: Salmeterol
Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks
Arzneimittel: Salmeterol Inhalation Powder
Salmeterol inhalation powder inhaled orally twice daily for 12 weeks
Arzneimittel: 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
Arzneimittel: Placebo Inhalation Powder Diskus
Placebo inhalation powder inhaled orally twice daily for 12 weeks
Arzneimittel: Placebo Inhalation Powder NDPI
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2010

Primärer Abschluss (Tatsächlich)

1. August 2011

Studienabschluss (Tatsächlich)

26. August 2011

Studienanmeldedaten

Zuerst eingereicht

15. Juli 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. August 2010

Zuerst gepostet (Schätzen)

13. August 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. November 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Oktober 2017

Zuletzt verifiziert

1. Oktober 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 112060

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Studiendaten/Dokumente

  1. Klinischer Studienbericht
    Informationskennung: 112060
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  2. Kommentiertes Fallberichtsformular
    Informationskennung: 112060
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  3. Einwilligungserklärung
    Informationskennung: 112060
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistischer Analyseplan
    Informationskennung: 112060
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  5. Einzelner Teilnehmerdatensatz
    Informationskennung: 112060
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  6. Studienprotokoll
    Informationskennung: 112060
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  7. Datensatzspezifikation
    Informationskennung: 112060
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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