Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD
A12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of GSK573719 Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Inhaled bronchodilators, such as beta 2 agonists and anticholinergics, and inhaled corticosteroids are the mainstays of therapy in patients diagnosed with COPD. Anticholinergic bronchodilators or long acting muscarinic receptor antagonists function by blocking endogenous airway smooth muscle cholinergic tone. Treatment with anticholinergics has been shown to significantly improve forced expiratory volume in 1 second (FEV1), resting and dynamic lung hyperinflation, symptoms, and exercise capacity in patients with COPD. Currently tiotropium is the only approved long acting muscarinic antagonist available for treatment of COPD.This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of GSK573719 Inhalation Powder of 2 doses when administered once-daily via Novel DPI compared with placebo over a treatment period of 12 weeks in subjects with COPD. There will be a total of 8 study clinic visits conducted on an outpatient basis. Subjects who meet the eligibility criteria at Screening (Visit 1) will complete a 5 to 9 days run-in period followed by a 12-week treatment period. There will be 8 clinic visits during three of which serial spirometry will be performed . The total duration of subject participation in the study will be approximately 14 weeks.
This is a Phase III multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of GSK573719 Inhalation Powder 62.5 mcg and 125 mcg when administered once-daily via Novel DPI compared with placebo over a treatment period of 12 weeks in subjects with COPD.
Eligible subjects will be randomized 1:1:1 to receive either of the two doses of GSK573719 Inhalation Powder doses or placebo for 12 weeks.
There will be a total of 8 study clinic visits conducted on an outpatient basis. Subjects who meet the eligibility criteria at Screening (Visit 1) will complete a 5 to 9 days run-in period followed by a 12-week treatment period. Clinic visits will be at Screening, Randomization (Visit 2), Day 3 and Weeks 2, 4, 8, and 12, and 1 day after the Week 12 visit (Visits 1 to 8, respectively). A safety follow-up assessment will be conducted by telephone approximately 7 days after the end of the study treatment (FU Phone Contact). The total duration of subject participation, including the follow-up period will be approximately 14 weeks. All subjects will be provided with albuterol/salbutamol for use on an "as-needed" basis throughout the run-in and treatment periods.
Pre-dose spirometry will be conducted at each clinic visit. Six hour post-dose serial spirometry will be conducted at Visit 2 and at Visits 5 and 7. All subjects will be provided with a paper diary for completion everyday throughout the run-in period and 12-week treatment period. Subjects will use the diary to record their daily use of supplemental albuterol/salbutamol and to record any medical problems experienced and any medications used.
At Visit 2 the Baseline Dyspnea Index (BDI) will be administered. The Transition Dyspnea Index (TDI) will be administered at Visits 5, 6, and 7.
Disease specific health status will be evaluated using the St. George's Respiratory Questionnaire (SGRQ) at Visit 2 and Visits 5, 6 and 7. Vital signs (blood pressure and pulse rate), 12-lead ECGs and standard clinical laboratory tests (hematology and blood biochemistry) including pharmacokinetic samples will be obtained at selected clinic visits.
Approximately 198 subjects will be randomized to ensure at least 168 subjects complete the treatment period.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Ibaraki, Japonsko, 319-1113
- GSK Investigational Site
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Kagawa, Japonsko, 762-0031
- GSK Investigational Site
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Kyoto, Japonsko, 612-0026
- GSK Investigational Site
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Osaka, Japonsko, 530-0001
- GSK Investigational Site
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Tokyo, Japonsko, 103-0027
- GSK Investigational Site
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Berlin, Německo, 10367
- GSK Investigational Site
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Berlin, Německo, 13086
- GSK Investigational Site
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Berlin, Německo, 10117
- GSK Investigational Site
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Berlin, Německo, 10717
- GSK Investigational Site
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Berlin, Německo, 13187
- GSK Investigational Site
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Hessen
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Frankfurt, Hessen, Německo, 60389
- GSK Investigational Site
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Gelnhausen, Hessen, Německo, 63571
- GSK Investigational Site
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Kassel, Hessen, Německo, 34121
- GSK Investigational Site
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Niedersachsen
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Hannover, Niedersachsen, Německo, 30173
- GSK Investigational Site
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Weyhe-Leeste, Niedersachsen, Německo, 28844
- GSK Investigational Site
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Nordrhein-Westfalen
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Goch, Nordrhein-Westfalen, Německo, 47574
- GSK Investigational Site
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Koeln, Nordrhein-Westfalen, Německo, 51069
- GSK Investigational Site
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Solingen, Nordrhein-Westfalen, Německo, 42651
- GSK Investigational Site
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Rheinland-Pfalz
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Koblenz, Rheinland-Pfalz, Německo, 56068
- GSK Investigational Site
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Sachsen
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Leipzg, Sachsen, Německo, 04109
- GSK Investigational Site
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Leipzig, Sachsen, Německo, 04103
- GSK Investigational Site
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Sachsen-Anhalt
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Teuchern, Sachsen-Anhalt, Německo, 06682
- GSK Investigational Site
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Schleswig-Holstein
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Luebeck, Schleswig-Holstein, Německo, 23552
- GSK Investigational Site
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Louisiana
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Sunset, Louisiana, Spojené státy, 70584
- GSK Investigational Site
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South Carolina
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Easley, South Carolina, Spojené státy, 29640
- GSK Investigational Site
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Spartanburg, South Carolina, Spojené státy, 29303
- GSK Investigational Site
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Union, South Carolina, Spojené státy, 29379
- GSK Investigational Site
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Diagnosis of COPD
- 10 pack-year or greater history of cigarette smoking
- Post-bronchodilator FEV1/FVC of <0.7
- Predicted FEV1 of 70% of normal or less
- Modified Medical Research Council (mMRC) dyspnea score of 2 or greater
Exclusion Criteria:
- Women who are pregnant, lactating, or planning to become pregnant
- Respiratory disorders other than COPD, including a current diagnosis of asthma
- Clinically significant non-respiratory diseases or abnormalities that are not adequately controlled
- Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the excipients of magnesium stereate or lactose used in the inhaler delivery device
- Hospitalization for COPD or pneumonia within 12 weeks prior to screening
- Lung volume reduction surgery within 12 weeks prior to screening
- Abnormal and clinically significant ECG findings at screening
- Clinically significant laboratory findings at screening
- Use of systemic corticosteroids, antibiotics for respiratory tract infections, high dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit
- Use of long-term oxygen therapy (12 hours or greater per day)
- Regular use of nebulized treatment with short-acting bronchodilators
- Participation in the acute phase of a pulmonary rehabilitation program
- A know or suspected history of alcohol or drug abuse
- Affiliation with the investigational site
- Previous use of GSK573719 or the combination of GSK573719/GW642444
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: GSK573719
active drug
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62.5 mcg
125mcg
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Komparátor placeba: Placebo
no active drug
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Placebo
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85
Časové okno: Baseline and Day 85
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.
Trough FEV1 measurements were taken electronically by spirometry on Days 2, 14, 28, 56, 84, and 85.
Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 85 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 84).
Change from Baseline was calculated as the trough FEV1 minus the Baseline.
Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions.
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Baseline and Day 85
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Days 1, 28 (Week 4) and 84 (Week 12)
Časové okno: Baseline and Days 1, 28 and 84
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.
The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated.
The WM was calculated at Days 1, 28, and Day 84 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 1 hour, 3 hours, and 6 hours.
Change from Baseline was the WM minus Baseline.
Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.
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Baseline and Days 1, 28 and 84
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Change From Baseline in Serial FEV1 Over 24 Hours Post-dose at Days 1 and 84 (Week 12)
Časové okno: Baseline, Day 1 and Day 84
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Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second.
Serial FEV1 measurements were taken electronically by spirometry.
Serial FEV1 measurements of interest for Day 1 were collected at 1, 3, 6, 23 and 24 hours post-dose on Day 1 and for Day 84, the measures were pre-dose (24 hours post-dose of Day 83 morning dose but prior to Day 84's dose) and 1, 3, 6, 23 and 24 hours post dose on Day 84.
Baseline is the mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1. Change from Baseline was calculated as FEV1 value at the evaluated time point minus Baseline.
Analysis performed separately by Visit/Day using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, time, time by Baseline and time by treatment interactions.
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Baseline, Day 1 and Day 84
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 115408
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Studijní data/dokumenty
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Protokol studie
Identifikátor informace: 115408Komentáře 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: 115408Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Formulář informovaného souhlasu
Identifikátor informace: 115408Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Zpráva o klinické studii
Identifikátor informace: 115408Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Specifikace datové sady
Identifikátor informace: 115408Komentáře 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: 115408Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Plán statistické analýzy
Identifikátor informace: 115408Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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