A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD
23 novembre 2016 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
187
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Fukuoka, Giappone, 811-2201
- GSK Investigational Site
-
Fukuoka, Giappone, 819-8555
- GSK Investigational Site
-
Fukushima, Giappone, 964-0871
- GSK Investigational Site
-
Gunma, Giappone, 371-0048
- GSK Investigational Site
-
Hiroshima, Giappone, 732-0057
- GSK Investigational Site
-
Hokkaido, Giappone, 001-0901
- GSK Investigational Site
-
Hokkaido, Giappone, 064-0915
- GSK Investigational Site
-
Hokkaido, Giappone, 070-8644
- GSK Investigational Site
-
Hyogo, Giappone, 651-0073
- GSK Investigational Site
-
Ibaraki, Giappone, 300-0053
- GSK Investigational Site
-
Ibaraki, Giappone, 310-0015
- GSK Investigational Site
-
Ishikawa, Giappone, 920-8610
- GSK Investigational Site
-
Kagawa, Giappone, 760-0073
- GSK Investigational Site
-
Kagawa, Giappone, 763-8502
- GSK Investigational Site
-
Kanagawa, Giappone, 239-0821
- GSK Investigational Site
-
Kyoto, Giappone, 601-1495
- GSK Investigational Site
-
Kyoto, Giappone, 615-8087
- GSK Investigational Site
-
Miyagi, Giappone, 981-8563
- GSK Investigational Site
-
Miyagi, Giappone, 984-8560
- GSK Investigational Site
-
Nagano, Giappone, 390-0303
- GSK Investigational Site
-
Nagano, Giappone, 390-0832
- GSK Investigational Site
-
Nagano, Giappone, 390-8601
- GSK Investigational Site
-
Nagano, Giappone, 391-0011
- GSK Investigational Site
-
Oita, Giappone, 870-0921
- GSK Investigational Site
-
Oita, Giappone, 876-0047
- GSK Investigational Site
-
Okayama, Giappone, 701-0304
- GSK Investigational Site
-
Osaka, Giappone, 545-8586
- GSK Investigational Site
-
Osaka, Giappone, 530-0012
- GSK Investigational Site
-
Osaka, Giappone, 576-0016
- GSK Investigational Site
-
Osaka, Giappone, 589-0022
- GSK Investigational Site
-
Tokyo, Giappone, 185-0014
- GSK Investigational Site
-
Tokyo, Giappone, 187-0024
- GSK Investigational Site
-
Toyama, Giappone, 930-0194
- GSK Investigational Site
-
Wakayama, Giappone, 641-8510
- GSK Investigational Site
-
Yamanashi, Giappone, 400-0031
- GSK Investigational Site
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
40 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
Lasso di tempo: 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
Lasso di tempo: 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])
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With Pneumonia During the Treatment Period
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2010
Completamento primario (Effettivo)
1 gennaio 2012
Completamento dello studio (Effettivo)
1 gennaio 2012
Date di iscrizione allo studio
Primo inviato
30 agosto 2010
Primo inviato che soddisfa i criteri di controllo qualità
30 agosto 2010
Primo Inserito (Stima)
31 agosto 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
11 gennaio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 novembre 2016
Ultimo verificato
1 novembre 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Malattie polmonari, ostruttive
- Malattie polmonari
- Malattia polmonare, cronica ostruttiva
- Effetti fisiologici delle droghe
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Agenti antinfiammatori
- Agenti dermatologici
- Agenti broncodilatatori
- Agenti antiasmatici
- Agenti del sistema respiratorio
- Agenti antiallergici
- Fluticasone
- Xhance
Altri numeri di identificazione dello studio
- 114156
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Sì
Descrizione del piano IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Dati/documenti di studio
-
Rapporto di studio clinico
Identificatore informazioni: 114156Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Protocollo di studio
Identificatore informazioni: 114156Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Modulo di consenso informato
Identificatore informazioni: 114156Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Modulo di segnalazione del caso annotato
Identificatore informazioni: 114156Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Piano di analisi statistica
Identificatore informazioni: 114156Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Specifica del set di dati
Identificatore informazioni: 114156Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Set di dati del singolo partecipante
Identificatore informazioni: 114156Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .