| Статус: |
Завершено
|
| Протокол № | №200812 |
| Тип: | ММКИ |
| Фаза: | IIIb |
| РКИ № | 241 от 11 апреля 2016 г. |
| Начало: | 11 апреля 2016 г. |
| Окончание: | 1 декабря 2017 г. |
| Пациентов: | 250 |
| Наименование протокола: | 200812 "24-недельное рандомизированное, двойное слепое исследование функции легких IIIb фазы с целью сравнения "закрытой" тройной терапии (ФФ/УМЕК/ВИ) с "открытой" тройной терапией (ФФ/ВИ + УМЕК) у пациентов с хронической обструктивной болезнью легких (ХОБЛ) |
| Цель исследования: | Изучение функции легких с целью сравнения «закрытой» тройной терапии (ФФ/УМЕК/ВИ) с «открытой» тройной терапией (ФФ/ВИ + УМЕК) у пациентов с хронической обструктивной болезнью легких. |
| Препарат(ы): | Умеклидиний (GSK573719, УМЕК)/Вилантерол (GW642444, ВИ)/Флутиказона фуроат (GW685698, ФФ) |
| Лекарственная форма: | Порошок для ингаляций дозированный (умеклидиний 62,5 мкг/вилантерол 25 мкг/флутиказона фуроат 100 мкг). |
| Разработчик: | ГлаксоСмитКляйн Рисерч энд Дивелопмент Лимитед |
| Страна: | Великобритания |
| CRO: | ЗАО «ГлаксоСмитКляйн Трейдинг», г. Москва, 119180, Якиманская наб., д. 2, Россия |
| Терапевтические области: | Пульмонология; |
Дополнительная информация:
ClinicalTrials.gov Comparative Study of Fluticasone Furoate(FF)/Umeclidinium Bromide (UMEC)/ Vilanterol (VI) Closed Therapy Versus FF/VI Plus UMEC Open Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
| Статус: | Completed |
| Фаза: | Phase 3 |
| Начало: | 29 июня 2016 г. |
| Окончание: | 23 мая 2017 г. |
| Описание: | This multicenter study will be conducted to compare the effect of FF/UMEC/VI with FF/VI plus UMEC on lung function after 24 weeks of treatment. This is a phase IIIB, 24-week, randomized, double-blind, parallel group multicenter study. This study will test the hypothesis that the difference in trough forced expiratory volume in one second (FEV1) between treatment groups is less than or equal to a pre-specified non-inferiority margin. Alternatively, this study will also test the hypothesis that the difference between treatment groups is greater than the margin. The triple therapy of FF/UMEC/VI in a single inhaler is being developed with the aim of providing a new treatment option for the management of advanced Global Initiative for Chronic Obstructive Lung Disease (GOLD) Group D COPD which will reduce the exacerbation frequency, allow for a reduced burden of polypharmacy, convenience, and improve lung function, health related quality of life (HRQoL) and symptom control over established dual/monotherapies. This study has a 2 week run in period where subjects will continue to have their existing COPD medications. At randomization, subjects will discontinue all existing COPD medications and will be assigned to treatment of FF/UMEC/VI, 100 microgram (mcg)/62.5 mcg/25 mcg and placebo or FF/VI, 100 mcg/25 mcg and UMEC, 62.5 mcg in a 1:1 ratio for 24 weeks. Subjects will have clinical visits at Pre-Screening (Visit 0), Screening (Visit 1), Randomization (Week 0, Visit 2), Week 4 (Visit 3), Week 12 (Visit 4) and Week 24 (Visit 5). A follow-up visit will be conducted at 1 week after the end of treatment period or after early withdrawal visit. Approximately, 1020 subjects will be enrolled in this study. There will be two pharmacokinetic (PK) groups (subset A and subset B). Approximately 120 subjects will be assigned to subset A and approximately 60 subjects will be assigned to subset B. The total duration of subject participation will be approximately 27 weeks, consisting of a 2-week run-in period, 24-week treatment period and a 1-week follow-up period. |
| смотреть на ClinicalTrials.gov |