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Long-term Safety Study for GSK573719 in Japanese (AC4115361)

18. november 2016 opdateret af: GlaxoSmithKline

A 52-week, Multi-centre, Open-label Study to Evaluate the Safety and Tolerability of GSK573719 125 mcg Once-daily Via Novel Dry Powder Inhaler (nDPI) in Japanese Subjects With Chronic Obstructive Pulmonary Disease.

The objective of this study is to evaluate the safety and tolerability of GSK573719 Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Chronic Obstructive Pulmonary Disease (COPD) treatment guidelines recommend an incremental approach to pharmacological treatment as the disease state worsens, involving the use of combinations of drug classes with different or complementary mechanisms of action [Celli, 2004, GOLD 2009]. As disease progresses from mild to moderate, regular treatment with one or more long-acting bronchodilators is recommended. Inhaled bronchodilators, including beta2 agonists and anticholinergics are included with inhaled corticosteroids (ICS) therapy and are mainstays of therapy in patients diagnosed with COPD. Since GSK573719 Inhalation Powder is expected to be used for chronic management of COPD as long-acting muscarinic antagonist (LAMA), this study is intended to evaluate the safety and tolerability of long-term administration of GSK573719 Inhalation Powder 125 mcg in Japanese patients with COPD at doses possibly used to be in Japan.

In this study, patient safety will also be monitored by evaluating pulmonary function and clinical symptoms.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

131

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
      • Fukuoka, Japan, 811-1347
        • GSK Investigational Site
      • Gunma, Japan, 371-0048
        • GSK Investigational Site
      • Hokkaido, Japan, 080-0805
        • GSK Investigational Site
      • Hyogo, Japan, 670-0849
        • GSK Investigational Site
      • Ibaraki, Japan, 300-0053
        • GSK Investigational Site
      • Ibaraki, Japan, 302-0022
        • GSK Investigational Site
      • Ishikawa, Japan, 920-8610
        • GSK Investigational Site
      • Kanagawa, Japan, 239-0821
        • GSK Investigational Site
      • Kyoto, Japan, 601-1495
        • GSK Investigational Site
      • Miyagi, Japan, 983-0824
        • GSK Investigational Site
      • Nagano, Japan, 391-0011
        • GSK Investigational Site
      • Oita, Japan, 870-0921
        • GSK Investigational Site
      • Oita, Japan, 876-0047
        • GSK Investigational Site
      • Osaka, Japan, 589-0022
        • GSK Investigational Site
      • Osaka, Japan, 530-0001
        • GSK Investigational Site
      • Shizuoka, Japan, 436-0022
        • GSK Investigational Site
      • Tokyo, Japan, 103-0027
        • GSK Investigational Site
      • Tokyo, Japan, 153-8934
        • GSK Investigational Site
      • Tokyo, Japan, 192-0903
        • GSK Investigational Site
      • Yamanashi, Japan, 400-0031
        • GSK Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Outpatient.
  • A signed and dated written informed consent prior to study participation.
  • Japanese subjects 40 years of age or older at Visit 1.
  • Male or female subjects. A female is eligible if she is of: Non-child bearing potential or Child bearing potential agrees to one of the contraceptive methods.
  • Subjects with a clinical history of COPD in accordance with the definition by COPD domestic guideline.
  • Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Visit 1.
  • Subject with a measured post-salbutamol forced expiratory volume/forced vital capacity (FEV1/FVC) ratio of <70% and Subjects with a measured post-salbutamol FEV1 <80% of predicted normal values.

Exclusion Criteria (Visit 1):

  • Women who are pregnant or lactating or are planning on becoming pregnant during the study.
  • A current diagnosis of asthma.
  • Known respiratory disorders other than COPD.
  • Subjects with historical or current evidence of clinically significant abnormalities that are uncontrolled.
  • A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD.
  • Allergy or hypersensitivity to muscarinic, beta2-agonist, lactose/milk protein or magnesium stearate or a condition that contraindicates participation.
  • Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
  • Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1).
  • An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1.
  • Significantly abnormal finding from clinical chemistry or hematology, tests at Visit 1.
  • Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day.
  • Regular use (prescribed every day, not for as-needed use) of short-acting bronchodilators (e.g., salbutamol) via nebulized therapy.
  • Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1.
  • A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
  • Affiliation with Investigator Site.
  • Previous use of GSK573719, the GSK573719/GW642444 combination.
  • Use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer).

Exclusion Criteria (Visit 2):

- COPD Exacerbation during run-in period: Subject must not have experienced a COPD exacerbation or a lower respiratory tract infection during run-in or at Visit 2.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: GSK573719
125mcg
Medicin: GSK573719
GSK573719 inhalation powder inhaled orally once daily for 52 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period
Tidsramme: From the first dose of study medication up to 52 weeks
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. 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 or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.
From the first dose of study medication up to 52 weeks
Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period
Tidsramme: From the first dose of study medication up to 52 weeks
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).
From the first dose of study medication up to 52 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Tidsramme: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Tidsramme: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Tidsramme: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Tidsramme: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Tidsramme: BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Tidsramme: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Tidsramme: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Change From BL in Blood Pressure Throughout the Treatment Period
Tidsramme: BL(Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.
BL(Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Change From BL in Heart Rate Throughout the Treatment Period
Tidsramme: BL (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.
BL (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
Tidsramme: BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
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. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) >500 milliseconds (msec) or an uncorrected QT interval >600 msec, for participants with Bundle Branch Block QTc >530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD Visits were conducted for participants who completed the Week 24 Visit or withdrew before Week 24 and completed the Week 52 Visit or withdrew before Week 52, respectively. The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2012

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

20. september 2012

Først indsendt, der opfyldte QC-kriterier

4. oktober 2012

Først opslået (Skøn)

8. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 115361

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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. Annoteret sagsbetænkningsformular
    Informations-id: 115361
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formular til informeret samtykke
    Informations-id: 115361
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistisk analyseplan
    Informations-id: 115361
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individuelt deltagerdatasæt
    Informations-id: 115361
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Klinisk undersøgelsesrapport
    Informations-id: 115361
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Datasætspecifikation
    Informations-id: 115361
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Studieprotokol
    Informations-id: 115361
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med GSK573719

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Betingelser

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