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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 ottobre 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

348

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

12 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Vilanterol
Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
Droga: Vilanterol
Vilanterol inhalation powder inhaled orally once daily for 12 weeks
Droga: Placebo Inhalation Powder Diskus
Placebo inhalation powder inhaled orally twice daily for 12 weeks
Comparatore attivo: Salmeterol
Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks
Droga: Salmeterol Inhalation Powder
Salmeterol inhalation powder inhaled orally twice daily for 12 weeks
Droga: Placebo Inhalation Powder NDPI
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
Comparatore placebo: Placebo
Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
Droga: Placebo Inhalation Powder Diskus
Placebo inhalation powder inhaled orally twice daily for 12 weeks
Droga: Placebo Inhalation Powder NDPI
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2010

Completamento primario (Effettivo)

1 agosto 2011

Completamento dello studio (Effettivo)

26 agosto 2011

Date di iscrizione allo studio

Primo inviato

15 luglio 2010

Primo inviato che soddisfa i criteri di controllo qualità

12 agosto 2010

Primo Inserito (Stima)

13 agosto 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 novembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 ottobre 2017

Ultimo verificato

1 ottobre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 112060

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Dati/documenti di studio

  1. Rapporto di studio clinico
    Identificatore informazioni: 112060
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Modulo di segnalazione del caso annotato
    Identificatore informazioni: 112060
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Modulo di consenso informato
    Identificatore informazioni: 112060
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Piano di analisi statistica
    Identificatore informazioni: 112060
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Set di dati del singolo partecipante
    Identificatore informazioni: 112060
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Protocollo di studio
    Identificatore informazioni: 112060
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Specifica del set di dati
    Identificatore informazioni: 112060
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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