A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD
23 november 2016 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
187
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
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
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
Tidsram: 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
Tidsram: 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])
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Pneumonia During the Treatment Period
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2010
Primärt slutförande (Faktisk)
1 januari 2012
Avslutad studie (Faktisk)
1 januari 2012
Studieregistreringsdatum
Först inskickad
30 augusti 2010
Först inskickad som uppfyllde QC-kriterierna
30 augusti 2010
Första postat (Uppskatta)
31 augusti 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
11 januari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 november 2016
Senast verifierad
1 november 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Lungsjukdomar, obstruktiv
- Lungsjukdomar
- Lungsjukdom, kronisk obstruktiv
- Läkemedels fysiologiska effekter
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Antiinflammatoriska medel
- Dermatologiska medel
- Bronkdilaterande medel
- Anti-astmatiska medel
- Andningsorgan
- Anti-allergiska medel
- Flutikason
- Xhance
Andra studie-ID-nummer
- 114156
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Ja
IPD-planbeskrivning
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokument
-
Klinisk studierapport
Informationsidentifierare: 114156Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokoll
Informationsidentifierare: 114156Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Informerat samtycke
Informationsidentifierare: 114156Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Annoterad fallrapportformulär
Informationsidentifierare: 114156Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistisk analysplan
Informationsidentifierare: 114156Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datauppsättningsspecifikation
Informationsidentifierare: 114156Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datauppsättning för individuella deltagare
Informationsidentifierare: 114156Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg
-
Pulmonary Research Institute of Southeast MichiganGlaxoSmithKlineAvslutad