A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD
23. listopadu 2016 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Typ studie
Intervenční
Zápis (Aktuální)
187
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Fukuoka, Japonsko, 811-2201
- GSK Investigational Site
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Fukuoka, Japonsko, 819-8555
- GSK Investigational Site
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Fukushima, Japonsko, 964-0871
- GSK Investigational Site
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Gunma, Japonsko, 371-0048
- GSK Investigational Site
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Hiroshima, Japonsko, 732-0057
- GSK Investigational Site
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Hokkaido, Japonsko, 001-0901
- GSK Investigational Site
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Hokkaido, Japonsko, 064-0915
- GSK Investigational Site
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Hokkaido, Japonsko, 070-8644
- GSK Investigational Site
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Hyogo, Japonsko, 651-0073
- GSK Investigational Site
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Ibaraki, Japonsko, 300-0053
- GSK Investigational Site
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Ibaraki, Japonsko, 310-0015
- GSK Investigational Site
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Ishikawa, Japonsko, 920-8610
- GSK Investigational Site
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Kagawa, Japonsko, 760-0073
- GSK Investigational Site
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Kagawa, Japonsko, 763-8502
- GSK Investigational Site
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Kanagawa, Japonsko, 239-0821
- GSK Investigational Site
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Kyoto, Japonsko, 601-1495
- GSK Investigational Site
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Kyoto, Japonsko, 615-8087
- GSK Investigational Site
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Miyagi, Japonsko, 981-8563
- GSK Investigational Site
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Miyagi, Japonsko, 984-8560
- GSK Investigational Site
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Nagano, Japonsko, 390-0303
- GSK Investigational Site
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Nagano, Japonsko, 390-0832
- GSK Investigational Site
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Nagano, Japonsko, 390-8601
- GSK Investigational Site
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Nagano, Japonsko, 391-0011
- GSK Investigational Site
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Oita, Japonsko, 870-0921
- GSK Investigational Site
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Oita, Japonsko, 876-0047
- GSK Investigational Site
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Okayama, Japonsko, 701-0304
- GSK Investigational Site
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Osaka, Japonsko, 545-8586
- GSK Investigational Site
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Osaka, Japonsko, 530-0012
- GSK Investigational Site
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Osaka, Japonsko, 576-0016
- GSK Investigational Site
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Osaka, Japonsko, 589-0022
- GSK Investigational Site
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Tokyo, Japonsko, 185-0014
- GSK Investigational Site
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Tokyo, Japonsko, 187-0024
- GSK Investigational Site
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Toyama, Japonsko, 930-0194
- GSK Investigational Site
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Wakayama, Japonsko, 641-8510
- GSK Investigational Site
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Yamanashi, Japonsko, 400-0031
- GSK Investigational Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
40 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Fluticasone Furoate/GW642444 100/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
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Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
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Experimentální: Fluticasone Furoate/GW642444 200/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
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Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
Časové okno: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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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.
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From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period
Časové okno: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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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.
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From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Number of Participants With Pneumonia During the Treatment Period
Časové okno: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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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
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From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)
Časové okno: Baseline (Week -2), and Week 52/Withdrawal (WD)
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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.
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Baseline (Week -2), and Week 52/Withdrawal (WD)
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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)
Časové okno: Baseline (Week -2), and Week 52/Withdrawal (WD
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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.
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Baseline (Week -2), and Week 52/Withdrawal (WD
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Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD)
Časové okno: Baseline (Week -2), Week 52/Withdrawal (WD)
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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.
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Baseline (Week -2), Week 52/Withdrawal (WD)
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Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD)
Časové okno: Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)
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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.
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Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)
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Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD
Časové okno: 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
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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.
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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
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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
Časové okno: 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
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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.
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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
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Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Časové okno: Baseline (Week -2), Week 12, Week 24, and Week 52
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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.
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Baseline (Week -2), Week 12, Week 24, and Week 52
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. srpna 2010
Primární dokončení (Aktuální)
1. ledna 2012
Dokončení studie (Aktuální)
1. ledna 2012
Termíny zápisu do studia
První předloženo
30. srpna 2010
První předloženo, které splnilo kritéria kontroly kvality
30. srpna 2010
První zveřejněno (Odhad)
31. srpna 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
11. ledna 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. listopadu 2016
Naposledy ověřeno
1. listopadu 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci dýchacích cest
- Plicní onemocnění, obstrukční
- Plicní onemocnění
- Plicní onemocnění, chronická obstrukční
- Fyziologické účinky léků
- Autonomní agenti
- Agenti periferního nervového systému
- Protizánětlivé látky
- Dermatologická činidla
- Bronchodilatační činidla
- Antiastmatická činidla
- Agenti dýchacího systému
- Antialergické látky
- Flutikason
- Xhance
Další identifikační čísla studie
- 114156
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ano
Popis plánu IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studijní data/dokumenty
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Zpráva o klinické studii
Identifikátor informace: 114156Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Protokol studie
Identifikátor informace: 114156Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulář informovaného souhlasu
Identifikátor informace: 114156Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Formulář komentované zprávy o případu
Identifikátor informace: 114156Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Plán statistické analýzy
Identifikátor informace: 114156Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Specifikace datové sady
Identifikátor informace: 114156Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Soubor dat jednotlivých účastníků
Identifikátor informace: 114156Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .