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

20. november 2016 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

646

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: placebo
matchende placebo
Legemiddel: Placebo
matchende placebo
Eksperimentell: fluticasone furoate/vilanterol
Inhaled corticosteroid/long acting beta-agonist
Legemiddel: fluticasone furoate/vilanterol
Inhaled corticosteroid/long acting beta-agonist

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2011

Primær fullføring (Faktiske)

1. september 2012

Studiet fullført (Faktiske)

1. september 2012

Datoer for studieregistrering

Først innsendt

9. juni 2011

Først innsendt som oppfylte QC-kriteriene

16. juni 2011

Først lagt ut (Anslag)

20. juni 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. januar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. november 2016

Sist bekreftet

1. november 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 113684

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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. Statistisk analyseplan
    Informasjonsidentifikator: 113684
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotert saksrapportskjema
    Informasjonsidentifikator: 113684
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Skjema for informert samtykke
    Informasjonsidentifikator: 113684
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Klinisk studierapport
    Informasjonsidentifikator: 113684
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Datasettspesifikasjon
    Informasjonsidentifikator: 113684
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Studieprotokoll
    Informasjonsidentifikator: 113684
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Datasett for individuell deltaker
    Informasjonsidentifikator: 113684
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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