Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD

23. november 2016 oppdatert av: GlaxoSmithKline

A Long-term Study to Evaluate the Safety and Tolerability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Japanese Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

187

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Japan
      • Fukuoka, Japan, 811-2201
        • GSK Investigational Site
      • Fukuoka, Japan, 819-8555
        • GSK Investigational Site
      • Fukushima, Japan, 964-0871
        • GSK Investigational Site
      • Gunma, Japan, 371-0048
        • GSK Investigational Site
      • Hiroshima, Japan, 732-0057
        • GSK Investigational Site
      • Hokkaido, Japan, 001-0901
        • GSK Investigational Site
      • Hokkaido, Japan, 064-0915
        • GSK Investigational Site
      • Hokkaido, Japan, 070-8644
        • GSK Investigational Site
      • Hyogo, Japan, 651-0073
        • GSK Investigational Site
      • Ibaraki, Japan, 300-0053
        • GSK Investigational Site
      • Ibaraki, Japan, 310-0015
        • GSK Investigational Site
      • Ishikawa, Japan, 920-8610
        • GSK Investigational Site
      • Kagawa, Japan, 760-0073
        • GSK Investigational Site
      • Kagawa, Japan, 763-8502
        • GSK Investigational Site
      • Kanagawa, Japan, 239-0821
        • GSK Investigational Site
      • Kyoto, Japan, 601-1495
        • GSK Investigational Site
      • Kyoto, Japan, 615-8087
        • GSK Investigational Site
      • Miyagi, Japan, 981-8563
        • GSK Investigational Site
      • Miyagi, Japan, 984-8560
        • GSK Investigational Site
      • Nagano, Japan, 390-0303
        • GSK Investigational Site
      • Nagano, Japan, 390-0832
        • GSK Investigational Site
      • Nagano, Japan, 390-8601
        • GSK Investigational Site
      • Nagano, Japan, 391-0011
        • GSK Investigational Site
      • Oita, Japan, 870-0921
        • GSK Investigational Site
      • Oita, Japan, 876-0047
        • GSK Investigational Site
      • Okayama, Japan, 701-0304
        • GSK Investigational Site
      • Osaka, Japan, 545-8586
        • GSK Investigational Site
      • Osaka, Japan, 530-0012
        • GSK Investigational Site
      • Osaka, Japan, 576-0016
        • GSK Investigational Site
      • Osaka, Japan, 589-0022
        • GSK Investigational Site
      • Tokyo, Japan, 185-0014
        • GSK Investigational Site
      • Tokyo, Japan, 187-0024
        • GSK Investigational Site
      • Toyama, Japan, 930-0194
        • GSK Investigational Site
      • Wakayama, Japan, 641-8510
        • GSK Investigational Site
      • Yamanashi, Japan, 400-0031
        • 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:

  • Out patient at least 40 years of age
  • Both genders; females childbearing potencial must be willing to use birth control method
  • A diagnosis of COPD at Screening
  • Subjects with a current or prior history of at least 10 pack-years of cigarett smoking at Screening
  • Post-bronchodilator FEV1/FVC ratio of less than 70%
  • Post-bronchodilator FEV1 of less than 80%

Exclusion Criteria:

  • Current diagnosis of sthma
  • Respiratory disorders other than COPD
  • Upper or lower respiratory infection, or exacerbation of COPD within 4 weeka prior to Screening
  • Concurrent other disease that would confound study participation or affect subject safety
  • Allergies to study drugs, study drugs' excipients, medications related to study drugs
  • Taking another investigational medication or medication prohibited for use during this study

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
Eksperimentell: Fluticasone Furoate/GW642444 100/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
Legemiddel: Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
Eksperimentell: Fluticasone Furoate/GW642444 200/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
Legemiddel: Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
Tidsramme: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAEs.
From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period
Tidsramme: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Relatedness was assessed by the investigator.
From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Pneumonia During the Treatment Period
Tidsramme: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Pneumonia is an inflammatory condition of the lung, affecting primarily the microscopic air sacs known as alveoli. All diagnoses of pneumonia (radiographically confirmed or unconfirmed) were reported as an AE or SAE. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the ot
From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)
Tidsramme: Baseline (Week -2), and Week 52/Withdrawal (WD)
Hematological parameters included: Basophils (Baso), Eosinophils (Eosin), Lymphocytes (Lymph), Monocytes (Mono), Total Neutrophils (TN), Hemoglobin (Hemo), Hematocrit (Hmcrt), Platelet Count (PT), Red Blood Cell Count (RBC Count), White Blood Cell Count (WBC Count). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.
Baseline (Week -2), and Week 52/Withdrawal (WD)
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)
Tidsramme: Baseline (Week -2), and Week 52/Withdrawal (WD
Clinical chemistry and urinalysis parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Bilirubin (Direct [BD], Indirect [BI], and Total [BT]), Creatine Kinase (CK), Chloride, Carbon Dioxide content/Bicarbonate (CO2/BC), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Lactate Dehydrogenase (LDH), Sodium, Urine pH, Urine Specific Gravity (USG),Total Protein (TP), Urea/Blood urea nitrogen (BUN), and Uric Acid (UA). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.
Baseline (Week -2), and Week 52/Withdrawal (WD
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD)
Tidsramme: Baseline (Week -2), Week 52/Withdrawal (WD)
Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.
Baseline (Week -2), Week 52/Withdrawal (WD)
Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD)
Tidsramme: Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)
24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD
Tidsramme: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD
Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD
Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD
Tidsramme: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD
Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at assessment time points (Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Tidsramme: Baseline (Week -2), Week 12, Week 24, and Week 52
A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Week 12, Week 24, and Week52). Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal findings. Any abnormal ECG, including those that worsen from baseline, and clinically significant as assessed by the investigator were recorded as CS.
Baseline (Week -2), Week 12, Week 24, and Week 52

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.

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. august 2010

Primær fullføring (Faktiske)

1. januar 2012

Studiet fullført (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først innsendt

30. august 2010

Først innsendt som oppfylte QC-kriteriene

30. august 2010

Først lagt ut (Anslag)

31. august 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. januar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. november 2016

Sist bekreftet

1. november 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 114156

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. Klinisk studierapport
    Informasjonsidentifikator: 114156
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Studieprotokoll
    Informasjonsidentifikator: 114156
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Skjema for informert samtykke
    Informasjonsidentifikator: 114156
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annotert saksrapportskjema
    Informasjonsidentifikator: 114156
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistisk analyseplan
    Informasjonsidentifikator: 114156
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Datasettspesifikasjon
    Informasjonsidentifikator: 114156
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Datasett for individuell deltaker
    Informasjonsidentifikator: 114156
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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. .

Abonnere