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A 24-week Study of Fluticasone Furoate/Vilanterol Inhalation Powder in Subjects of Asian Ancestry With COPD

20 novembre 2016 mis à jour par: GlaxoSmithKline

A 24-week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder Delivered Once Daily Via a Dry Powder Inhaler Compared With Placebo in Subjects of Asian Ancestry With Chronic Obstructive Pulmonary Disease

The purpose of the study is to investigate the efficacy and safety of fluticasone furoate/vilanterol Inhalation Powder compared with placebo over a 24 weeks treatment period in subjects of Asian ancestry with Chronic Obstructive Pulmonary Disease (COPD).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

646

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
      • Beijing, Chine, 100034
        • GSK Investigational Site
      • Beijing, Chine, 100191
        • GSK Investigational Site
      • Beijing, Chine, 100020
        • GSK Investigational Site
      • Beijing, Chine, 100048
        • GSK Investigational Site
      • Changsha, Chine, 410013
        • GSK Investigational Site
      • Chengdu, Chine, 610041
        • GSK Investigational Site
      • Chongqing, Chine, 400038
        • GSK Investigational Site
      • Chongqing, Chine, 400037
        • GSK Investigational Site
      • Shanghai, Chine, 200025
        • GSK Investigational Site
      • Shanghai, Chine, 200433
        • GSK Investigational Site
      • Shanghai, Chine, 200080
        • GSK Investigational Site
      • Tianjin, Chine, 300052
        • GSK Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, Chine, 510515
        • GSK Investigational Site
      • Guangzhou, Guangdong, Chine, 510120
        • GSK Investigational Site
    • Guangxi
      • Nanning, Guangxi, Chine, 530021
        • GSK Investigational Site
    • Hunan
      • Changsha, Hunan, Chine, 410011
        • GSK Investigational Site
    • Liaoning
      • Shenyang, Liaoning, Chine, 110015
        • GSK Investigational Site
      • Shenyang, Liaoning, Chine, 110001
        • GSK Investigational Site
    • Shaanxi
      • Xian, Shaanxi, Chine, 710032
        • GSK Investigational Site
      • Xian, Shaanxi, Chine, 710061
        • GSK Investigational Site
    • Zhejiang
      • Hang Zhou, Zhejiang, Chine, 310003
        • GSK Investigational Site
  • Corée, République de
      • Seoul, Corée, République de, 158-710
        • GSK Investigational Site
      • Suwon, Gyeonggi-do, Corée, République de, 442-723
        • GSK Investigational Site
      • jeonju-si, Jeollabuk-Do, Corée, République de, 561-712
        • GSK Investigational Site
  • Philippines
      • Quezon City, Philippines, 1100
        • GSK Investigational Site
      • Quezon City, Philippines, 1109
        • GSK Investigational Site
  • Taïwan
      • Changhua, Taïwan, 500
        • GSK Investigational Site
      • Kaohsiung, Taïwan, 833
        • GSK Investigational Site
      • Taichung, Taïwan, 404
        • GSK Investigational Site
      • Taichung, Taïwan, 40705
        • GSK Investigational Site
      • Taichung, Taïwan, 40201
        • GSK Investigational Site
      • Taipei, Taïwan, 100
        • GSK Investigational Site
      • Taipei, Taïwan, 112
        • GSK Investigational Site
      • Tau-Yuan County, Taïwan, 333
        • GSK Investigational Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • COPD diagnosis define by ATS(American Thoracic Society)/ ERS (European Respiratory Society)
  • Subjects of Asian ancestry
  • Valid informed consent
  • Current or former smoker
  • > or = 2 on the modified Medical Research Council Dyspnea Scale at Screening

Exclusion Criteria:

  • Pregnancy
  • A current diagnosis of asthma
  • alpha1-antitrypsin deficiency as the underlying cause for COPD
  • Other active, respiratory disorders
  • Have lung volume reduction surgery within 12 months prior to Screening
  • A chest X-ray or CT (Computerised Tomography) scan reveals evidence of clinical significant abnormalities not believed to be due to the presence of COPD
  • Poorly controlled COPD: acute worsening of COPD managed by corticosteroids, antibiotics, or treatments prescribed by a physician 6 weeks prior to Screening, or requires hospitalisation due to poorly controlled COPD 12 weeks prior to Screening
  • Lower respiratory tract infection requires antibiotics within 4 weeks prior to Screening
  • Other disease or abnormalities, in the opinion of the investigator, would put the safety of the subject at risk during the study or would affect safety or efficacy analysis if the disease/condition exacerbated during the study
  • Subject with carcinoma that has not been in complete remission for at least 5 years, carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
  • Subject has a history of hypersensitivity to any of the study medications or components of the inhalation powder. Subject has a history of severe milk protein allergy that, in the opinion of the investigator, contraindicates the subject's participation will also be excluded.
  • Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years prior to Screening
  • Subjects who are medically unable to withhold albuterol, ipratropium for 4 hrs and/or theophylline for 12 hrs prior to spirometry testing.
  • Subjects use a list of prohibited medications specified in the study protocol, including but not limited to traditional or herbal medications for the treatment of COPD
  • Subject requires long-term oxygen therapy or nocturnal oxygen therapy for greater than 12 hours a day
  • Pulmonary rehabilitation: subjects who are in the maintenance phase are not excluded.
  • Non-compliance
  • Questionable validity of the Informed Consent
  • Prior use of study medication or other investigational drugs
  • Affiliation with investigator site

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: placebo
placebo correspondant
Médicament: Placebo
placebo correspondant
Expérimental: fluticasone furoate/vilanterol
Inhaled corticosteroid/long acting beta-agonist
Médicament: fluticasone furoate/vilanterol
Inhaled corticosteroid/long acting beta-agonist

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169
Délai: Baseline to Day 169
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 was defined as the pre-dose and pre-bronchodilator FEV1, which was obtained at each clinic visit. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing at each clinic visit. Change from Baseline was calculated as the average at each clinic visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), baseline - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, day, day by baseline and day by treatment interactions.
Baseline to Day 169

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168
Délai: Baseline (BL) and Day 168
CRQ-SAS measures 4 domains (fatigue, emotional function, mastery and dyspnea) of functioning of participants (par.) with COPD: mastery (amount of control the par. feels he/she has over COPD symptoms); fatigue (how tired the par. feels); emotional function (how anxious/depressed the par. feels); and dyspnea (how short of breath the par. feels during physical activities). Each domain is calculated separately and measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Dyspnea domain score is the mean of all non-missing responses for that domain. Only the dyspnea domain was measured as a secondary outcome. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average of the Day 168 values minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), day, day by BL, and day by treatment interactions.
Baseline (BL) and Day 168

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

GlaxoSmithKline

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2011

Achèvement primaire (Réel)

1 septembre 2012

Achèvement de l'étude (Réel)

1 septembre 2012

Dates d'inscription aux études

Première soumission

9 juin 2011

Première soumission répondant aux critères de contrôle qualité

16 juin 2011

Première publication (Estimation)

20 juin 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

11 janvier 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 novembre 2016

Dernière vérification

1 novembre 2016

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 113684

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Données/documents d'étude

  1. Plan d'analyse statistique
    Identifiant des informations: 113684
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formulaire de rapport de cas annoté
    Identifiant des informations: 113684
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formulaire de consentement éclairé
    Identifiant des informations: 113684
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  4. Rapport d'étude clinique
    Identifiant des informations: 113684
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  5. Spécification du jeu de données
    Identifiant des informations: 113684
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  6. Protocole d'étude
    Identifiant des informations: 113684
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  7. Ensemble de données de participant individuel
    Identifiant des informations: 113684
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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