A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD
keskiviikko 23. marraskuuta 2016 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
187
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
-
Fukuoka, Japani, 811-2201
- GSK Investigational Site
-
Fukuoka, Japani, 819-8555
- GSK Investigational Site
-
Fukushima, Japani, 964-0871
- GSK Investigational Site
-
Gunma, Japani, 371-0048
- GSK Investigational Site
-
Hiroshima, Japani, 732-0057
- GSK Investigational Site
-
Hokkaido, Japani, 001-0901
- GSK Investigational Site
-
Hokkaido, Japani, 064-0915
- GSK Investigational Site
-
Hokkaido, Japani, 070-8644
- GSK Investigational Site
-
Hyogo, Japani, 651-0073
- GSK Investigational Site
-
Ibaraki, Japani, 300-0053
- GSK Investigational Site
-
Ibaraki, Japani, 310-0015
- GSK Investigational Site
-
Ishikawa, Japani, 920-8610
- GSK Investigational Site
-
Kagawa, Japani, 760-0073
- GSK Investigational Site
-
Kagawa, Japani, 763-8502
- GSK Investigational Site
-
Kanagawa, Japani, 239-0821
- GSK Investigational Site
-
Kyoto, Japani, 601-1495
- GSK Investigational Site
-
Kyoto, Japani, 615-8087
- GSK Investigational Site
-
Miyagi, Japani, 981-8563
- GSK Investigational Site
-
Miyagi, Japani, 984-8560
- GSK Investigational Site
-
Nagano, Japani, 390-0303
- GSK Investigational Site
-
Nagano, Japani, 390-0832
- GSK Investigational Site
-
Nagano, Japani, 390-8601
- GSK Investigational Site
-
Nagano, Japani, 391-0011
- GSK Investigational Site
-
Oita, Japani, 870-0921
- GSK Investigational Site
-
Oita, Japani, 876-0047
- GSK Investigational Site
-
Okayama, Japani, 701-0304
- GSK Investigational Site
-
Osaka, Japani, 545-8586
- GSK Investigational Site
-
Osaka, Japani, 530-0012
- GSK Investigational Site
-
Osaka, Japani, 576-0016
- GSK Investigational Site
-
Osaka, Japani, 589-0022
- GSK Investigational Site
-
Tokyo, Japani, 185-0014
- GSK Investigational Site
-
Tokyo, Japani, 187-0024
- GSK Investigational Site
-
Toyama, Japani, 930-0194
- GSK Investigational Site
-
Wakayama, Japani, 641-8510
- GSK Investigational Site
-
Yamanashi, Japani, 400-0031
- GSK Investigational Site
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
40 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Fluticasone Furoate/GW642444 100/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
|
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
|
|
Kokeellinen: Fluticasone Furoate/GW642444 200/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
|
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
Aikaikkuna: 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
Aikaikkuna: 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])
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of Participants With Pneumonia During the Treatment Period
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Sunnuntai 1. elokuuta 2010
Ensisijainen valmistuminen (Todellinen)
Sunnuntai 1. tammikuuta 2012
Opintojen valmistuminen (Todellinen)
Sunnuntai 1. tammikuuta 2012
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 30. elokuuta 2010
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 30. elokuuta 2010
Ensimmäinen Lähetetty (Arvio)
Tiistai 31. elokuuta 2010
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Keskiviikko 11. tammikuuta 2017
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 23. marraskuuta 2016
Viimeksi vahvistettu
Tiistai 1. marraskuuta 2016
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Hengityselinten sairaudet
- Keuhkosairaudet, obstruktiiviset
- Keuhkosairaudet
- Keuhkosairaus, krooninen obstruktiivinen
- Huumeiden fysiologiset vaikutukset
- Autonomiset agentit
- Ääreishermoston aineet
- Tulehdusta ehkäisevät aineet
- Dermatologiset aineet
- Keuhkoputkia laajentavat aineet
- Astmaattiset aineet
- Hengityselinten aineet
- Antiallergiset aineet
- Flutikasoni
- Xhance
Muut tutkimustunnusnumerot
- 114156
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Joo
IPD-suunnitelman kuvaus
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Tutkimustiedot/asiakirjat
-
Kliinisen tutkimuksen raportti
Tiedon tunniste: 114156Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Tutkimuspöytäkirja
Tiedon tunniste: 114156Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Ilmoitettu suostumuslomake
Tiedon tunniste: 114156Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Selosteilla varustettu tapausraporttilomake
Tiedon tunniste: 114156Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Tilastollinen analyysisuunnitelma
Tiedon tunniste: 114156Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Tietojoukon määritys
Tiedon tunniste: 114156Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Yksittäisen osallistujan tietojoukko
Tiedon tunniste: 114156Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Yhdysvalloissa valmistettu ja sieltä viety tuote
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg
-
GlaxoSmithKlineValmisKeuhkosairaus, krooninen obstruktiivinenArgentiina, Ranska, Saksa, Venäjän federaatio, Ukraina, Italia, Norja