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ТРОЙНОЙ ПРИ АСТМЕ ВЫСОКАЯ СИЛА ПО СРАВНЕНИЮ ИГКС/ЛАБА В и тиотропия (ТРИГГЕР) (TRIGGER)

2 июня 2026 г. обновлено: Chiesi Farmaceutici S.p.A.

52-НЕДЕЛЬНОЕ РАНДОМИЗИРОВАННОЕ ДВОЙНОЕ СЛЕПОЕ, МНОГОНАЦИОНАЛЬНОЕ, МНОГОЦЕНТРОВОЕ, АКТИВНО-КОНТРОЛИРУЕМОЕ, ПАРАЛЛЕЛЬНЫЕ ГРУППОВЫЕ ИССЛЕДОВАНИЯ В 3 РУКАХ, СРАВНЯЮЩИЕ CHF 5993 200/6/12,5 мкг pMDI (ФИКСИРОВАННАЯ КОМБИНАЦИЯ ЭКСТРАМЕЛКОГО БЕКЛОМЕТАЗОНА ДИПРОПИОНАТ ПЛЮС ФОРМОТЕРОЛ ФУМАРАТ 2005 БУМАРАТ ПЛЮС ГЛИКОПИЯ) /6 мкг pMDI (ФИКСИРОВАННАЯ КОМБИНАЦИЯ ЭКСТРАФАЙН БЕКЛОМЕТАЗОНА ДИПРОПИОНАТ ПЛЮС ФОРМОТЕРОЛ ФУМАРАТ) ОТДЕЛЬНО ИЛИ ПОВЕРХ ТИОТРОПИУМА 2,5 мкг РЕСПИМАТ® ОТКРЫТОЙ ЭТИКЕТКИ У ПАЦИЕНТОВ С АСТМОЙ, НЕ КОНТРОЛИРУЕМОЙ ПРИ ВЫСОКИХ ДОЗАХ ИНГАЛЯЦИОННЫХ КОРТИКОСТЕРОИДОВ В КОМБИНАЦИИ С β2-СТАРИТЕЛЯМИ ДЛИТЕЛЬНОГО ДЕЙСТВИЯ

Целью данного исследования является оценка превосходства CHF 5993 200/6/12,5 мкг pMDI (фиксированная комбинация экстрадисперсного беклометазона дипропионата плюс формотерола фумарата плюс гликопиррония бромид) по сравнению с CHF 1535 200/6 мкг pMDI (фиксированная комбинация экстрадисперсного беклометазона дипропионата плюс формотерола фумарата) и для сравнения эффекта CHF 5993 200/6/12,5 мкг pMDI против CHF 5993 200/6/12,5 мкг плюс открытый тиотропий 2,5 мкг, с точки зрения параметров функции легких и частоты обострений, а также для оценки его безопасности и некоторых экономических последствий для здоровья.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

This was a phase III, multicentre, randomised, double-blind study, with an open-label arm, active-controlled, 3-arm parallel group study to demonstrate both the superiority of CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg in terms of change from baseline in pre-dose FEV1 at Week 26 and a reduction of moderate and severe asthma exacerbation rate with CHF 5993 pMDI 200/6/12.5 μg compared to CHF 1535 pMDI 200/6 μg during the entire 52-week treatment period.

The study was performed in patients with uncontrolled asthma on high doses of inhaled corticosteroids (ICS) in combination with long acting β2-agonists LABAs). The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and all other requirements of local laws.

Patients completed the electronic diary (eDiary)/electronic peak flow meter (ePeakflowmeter) twice daily at home from screening to Week 52, recording asthma symptoms, treatment compliance, rescue intake and peak expiratory flow (PEF). The Asthma Control Questionnaire© (ACQ)-7 was completed at all visits from screening to Week 52. The EuroQuality of Life-5-Dimensional-3-Level (EQ-5D-3L™) questionnaire was completed at all visits from randomisation to Week 52. Health economic information was collected during the study. An independent Data Safety Monitoring Board was established for evaluation of the study and impartial safety assurance for patients. An Adjudication Committee was established to evaluate Major Adverse Cardiovascular Events.

Primary objective of the study were:

  • To demonstrate the superiority of CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg in terms of change from baseline in pre-dose forced expiratory volume in the 1st second (FEV1) at Week 26;
  • To demonstrate the reduction of moderate and severe asthma exacerbations rate with CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg during the entire 52-week treatment period.

The secondary endpoints included pooled analyse of 2 pivotal studies; this study (TRIGGER) and study (TRIMARAN). These 2 studies have similar study designs and study population.

CHF 1535 pMDI: fixed-dose combination (FDC) of BDP + FF + GB Dose: BDP 200 μg, FF 6 μg, GB 12.5 μg per actuation, 2 inhalations, BID. Total daily dose: BDP 800 μg, FF 24 μg, GB 50 μg.

BDP: Beclometasone dipropionate FF: Formoterol fumarate GB: Glycopyrronium bromide

Тип исследования

Интервенционный

Регистрация (Действительный)

1437

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Аргентина
      • Buenos Aires, Аргентина
        • Chiesi Clinical Trial Site 432702
      • CABA, Аргентина
        • Chiesi Clinical Trial Site 432704
      • Mar del Plata, Аргентина
        • Chiesi Clinical Trial Site 432705
      • Quilmes, Аргентина
        • Chiesi Clinical Trial Site 432701
      • San Miguel de Tucumán, Аргентина
        • Chiesi Clinical Trial Site 432703
      • San Miguel de Tucumán, Аргентина
        • Chiesi Clinical Trial Site 432706
  • Беларусь
      • Homyel, Беларусь
        • Chiesi Clinical Trial Site 112703
      • Homyel, Беларусь
        • Chiesi Clinical Trial Site 112704
      • Minsk, Беларусь
        • Chiesi Clinical Trial Site 112701
      • Minsk, Беларусь
        • Chiesi Clinical Trial Site 112702
      • Minsk, Беларусь
        • Chiesi Clinical Trial Site 112705
  • Болгария
      • Blagoevgrad, Болгария
        • Chiesi Clinical Trial Site 100707
      • Burgas, Болгария
        • Chiesi Clinical Trial Site 100720
      • Gabrovo, Болгария
        • Chiesi Clinical Trial Site 100718
      • Haskovo, Болгария
        • Chiesi Clinical Trial Site 100713
      • Montana, Болгария
        • Chiesi Clinical Trial Site 100722
      • Pleven, Болгария
        • Chiesi Clinical Trial Site 100702
      • Plovdiv, Болгария
        • Chiesi Clinical Trial Site 100705
      • Plovdiv, Болгария
        • Chiesi Clinical Trial Site 100708
      • Plovdiv, Болгария
        • Chiesi Clinical Trial Site 100715
      • Rousse, Болгария
        • Chiesi Clinical Trial Site 100716
      • Sofia, Болгария
        • Chiesi Clinical Trial Site 100701
      • Sofia, Болгария
        • Chiesi Clinical Trial Site 100703
      • Sofia, Болгария
        • Chiesi Clinical Trial Site 100704
      • Sofia, Болгария
        • Chiesi Clinical Trial Site 100709
      • Sofia, Болгария
        • Chiesi Clinical Trial Site 100719
      • Stara Zagora, Болгария
        • Chiesi Clinical Trial Site 100706
      • Stara Zagora, Болгария
        • Chiesi Clinical Trial Site 100712
      • Varna, Болгария
        • Chiesi Clinical Trial Site 100710
      • Vidin, Болгария
        • Chiesi Clinical Trial Site 100711
      • Vidin, Болгария
        • Chiesi Clinical Trial Site 100721
  • Венгрия
      • Balassagyarmat, Венгрия
        • Chiesi Clinical Trial Site 348707
      • Budapest, Венгрия
        • Chiesi Clinical Trial Site 348715
      • Debrecen, Венгрия
        • Chiesi Clinical Trial Site 348721
      • Gödöllő, Венгрия
        • Chiesi Clinical Trial Site 348712
      • Hatvan, Венгрия
        • Chiesi Clinical Trial Site 348718
      • Komárom, Венгрия
        • Chiesi Clinical Trial Site 348717
      • Létavértes, Венгрия
        • Chiesi Clinical Trial Site 348709
      • Monor, Венгрия
        • Chiesi Clinical Trial Site 348703
      • Mórahalom, Венгрия
        • Chiesi Clinical Trial Site 348719
      • Nyíregyháza, Венгрия
        • Chiesi Clinical Trial Site 348704
      • Nyíregyháza, Венгрия
        • Chiesi Clinical Trial Site 348714
      • Pécs, Венгрия
        • Chiesi Clinical Trial Site 348713
      • Pécs, Венгрия
        • Chiesi Clinical Trial Site 348720
      • Siófok, Венгрия
        • Chiesi Clinical Trial Site 348702
      • Szarvas, Венгрия
        • Chiesi Clinical Trial Site 348706
      • Szeged, Венгрия
        • Chiesi Clinical Trial Site 348701
      • Szombathely, Венгрия
        • Chiesi Clinical Trial Site 348705
      • Vásárosnamény, Венгрия
        • Chiesi Clinical Trial Site 348710
      • Érd, Венгрия
        • Chiesi Clinical Trial Site 348708
  • Германия
      • Berlin, Германия
        • Chiesi Clinical Trial Site 276709
      • Berlin, Германия
        • Chiesi Clinical Trial Site 276712
      • Bonn, Германия
        • Chiesi Clinical Trial Site 276711
      • Frankfurt am Main, Германия
        • Chiesi Clinical Trial Site 276707
      • Frankfurt am Main, Германия
        • Chiesi Clinical Trial Site 276714
      • Hamburg, Германия
        • Chiesi Clinical Trial Site 276705
      • Hanover, Германия
        • Chiesi Clinical Trial Site 276703
      • Koblenz, Германия
        • Chiesi Clinical Trial Site 276708
      • Leipzig, Германия
        • Chiesi Clinical Trial Site 276702
      • Leipzig, Германия
        • Chiesi Clinical Trial Site 276704
      • Leipzig, Германия
        • Chiesi Clinical Trial Site 276710
      • Mainz, Германия
        • Chiesi Clinical Trial Site 276715
      • München, Германия
        • Chiesi Clinical Trial Site 276701
      • Münster, Германия
        • Chiesi Clinical Trial Site 276713
      • Rosenheim, Германия
        • Chiesi Clinical Trial Site 276716
  • Испания
      • A Coruña, Испания
        • Chiesi Clinical Trial Site 724702
      • Badajoz, Испания
        • Chiesi Clinical Trial Site 724703
      • Badalona, Испания
        • Chiesi Clinical Trial Site 724706
      • Madrid, Испания
        • Chiesi Clinical Trial Site 724701
      • Madrid, Испания
        • Chiesi Clinical Trial Site 724704
      • Málaga, Испания
        • Chiesi Clinical Trial Site 724705
      • Sabadell, Испания
        • Chiesi Clinical Trial Site 724707
  • Италия
      • Bologna, Италия
        • Chiesi Clinical Trial Site 380704
      • Catania, Италия
        • Chiesi Clinical Trial Site 380703
      • Genova, Италия
        • Chiesi Clinical Trial Site 380701
      • Palermo, Италия
        • Chiesi Clinical Trial Site 380705
      • Pavia, Италия
        • Chiesi Clinical Trial Site 380702
      • Tradate, Италия
        • Chiesi Clinical Trial Site 380706
  • Литва
      • Vilnius, Литва
        • Chiesi Clinical Trial Site 440702
      • Vilnius, Литва
        • Chiesi Clinical Trial Site 440703
      • Vilnius, Литва
        • Chiesi Clinical Trial Site 440705
      • Šiauliai, Литва
        • Chiesi Clinical Trial Site 440701
  • Польша
      • Bialystok, Польша
        • Chiesi Clinical Trial Site 616713
      • Bialystok, Польша
        • Chiesi Clinical Trial Site 616718
      • Bielsko-Biala, Польша
        • Chiesi Clinical Trial Site 616722
      • Bienkówka, Польша
        • Chiesi Clinical Trial Site 616702
      • Bydgoszcz, Польша
        • Chiesi Clinical Trial Site 616727
      • Giżycko, Польша
        • Chiesi Clinical Trial Site 616704
      • Grudziądz, Польша
        • Chiesi Clinical Trial Site 616716
      • Katowice, Польша
        • Chiesi Clinical Trial Site 616725
      • Katowice, Польша
        • Chiesi Clinical Trial Site 616729
      • Krakow, Польша
        • Chiesi Clinical Trial Site 616719
      • Krakow, Польша
        • Chiesi Clinical Trial Site 616734
      • Krakow, Польша
        • Chiesi Clinical Trial Site 616736
      • Lodz, Польша
        • Chiesi Clinical Trial Site 616707
      • Lodz, Польша
        • Chiesi Clinical Trial Site 616708
      • Lodz, Польша
        • Chiesi Clinical Trial Site 616711
      • Lodz, Польша
        • Chiesi Clinical Trial Site 616726
      • Mrozy, Польша
        • Chiesi Clinical Trial Site 616733
      • Ostróda, Польша
        • Chiesi Clinical Trial Site 616717
      • Otwock, Польша
        • Chiesi Clinical Trial Site 616731
      • Pabianice, Польша
        • Chiesi Clinical Trial Site 616703
      • Poznan, Польша
        • Chiesi Clinical Trial Site 616709
      • Poznan, Польша
        • Chiesi Clinical Trial Site 616728
      • Proszowice, Польша
        • Chiesi Clinical Trial Site 616720
      • Rzeszów, Польша
        • Chiesi Clinical Trial Site 616723
      • Rzeszów, Польша
        • Chiesi Clinical Trial Site 616735
      • Skierniewice, Польша
        • Chiesi Clinical Trial Site 616721
      • Strzelce Opolskie, Польша
        • Chiesi Clinical Trial Site 616732
      • Tarnów, Польша
        • Chiesi Clinical Trial Site 616710
      • Warsaw, Польша
        • Chiesi Clinical Trial Site 616701
      • Wilkowice, Польша
        • Chiesi Clinical Trial Site 616730
      • Wroclaw, Польша
        • Chiesi Clinical Trial Site 616705
      • Wroclaw, Польша
        • Chiesi Clinical Trial Site 616714
      • Wroclaw, Польша
        • Chiesi Clinical Trial Site 616715
      • Świdnik, Польша
        • Chiesi Clinical Trial Site 616712
  • Португалия
      • Aveiro, Португалия
        • Chiesi Clinical Trial Site 620704
      • Figueira da Foz Municipality, Португалия
        • Chiesi Clinical Trial Site 620703
      • Lisbon, Португалия
        • Chiesi Clinical Trial Site 620702
      • Loures, Португалия
        • Chiesi Clinical Trial Site 620708
      • Vila Nova de Gaia, Португалия
        • Chiesi Clinical Trial Site 620707
  • Россия
      • Chelyabinsk, Россия
        • Chiesi Clinical Trial Site 643727
      • Chelyabinsk, Россия
        • Chiesi Clinical Trial Site 643733
      • Chelyabinsk, Россия
        • Chiesi Clinical Trial Site 643745
      • Izhevsk, Россия
        • Chiesi Clinical Trial Site 643754
      • Kazan', Россия
        • Chiesi Clinical Trial Site 643713
      • Kazan', Россия
        • Chiesi Clinical Trial Site 643719
      • Kazan', Россия
        • Chiesi Clinical Trial Site 643741
      • Kazan', Россия
        • Chiesi Clinical Trial Site 643746
      • Kemerovo, Россия
        • Chiesi Clinical Trial Site 643704
      • Kemerovo, Россия
        • Chiesi Clinical Trial Site 643731
      • Moscow, Россия
        • Chiesi Clinical Trial Site 643702
      • Moscow, Россия
        • Chiesi Clinical Trial Site 643705
      • Moscow, Россия
        • Chiesi Clinical Trial Site 643706
      • Moscow, Россия
        • Chiesi Clinical Trial Site 643718
      • Moscow, Россия
        • Chiesi Clinical Trial Site 643722
      • Moscow, Россия
        • Chiesi Clinical Trial Site 643735
      • Moscow, Россия
        • Chiesi Clinical Trial Site 643743
      • Nizhny Novgorod, Россия
        • Chiesi Clinical Trial Site 643707
      • Nizhny Novgorod, Россия
        • Chiesi Clinical Trial Site 643723
      • Nizhny Novgorod, Россия
        • Chiesi Clinical Trial Site 643744
      • Novosibirsk, Россия
        • Chiesi Clinical Trial Site 643717
      • Odintsovo, Россия
        • Chiesi Clinical Trial Site 643724
      • Orenburg, Россия
        • Chiesi Clinical Trial Site 643729
      • Pyatigorsk, Россия
        • Chiesi Clinical Trial Site 643711
      • Ryazan, Россия
        • Chiesi Clinical Trial Site 643701
      • Saint Petersburg, Россия
        • Chiesi Clinical Trial Site 643712
      • Saint Petersburg, Россия
        • Chiesi Clinical Trial Site 643714
      • Saint Petersburg, Россия
        • Chiesi Clinical Trial Site 643715
      • Saint Petersburg, Россия
        • Chiesi Clinical Trial Site 643716
      • Saint Petersburg, Россия
        • Chiesi Clinical Trial Site 643725
      • Saint Petersburg, Россия
        • Chiesi Clinical Trial Site 643730
      • Saint Petersburg, Россия
        • Chiesi Clinical Trial Site 643732
      • Saint Petersburg, Россия
        • Chiesi Clinical Trial Site 643737
      • Saint Petersburg, Россия
        • Chiesi Clinical Trial Site 643739
      • Saint Petersburg, Россия
        • Chiesi Clinical Trial Site 643752
      • Saint Petersburg, Россия
        • Chiesi Clinical Trial Site 643757
      • Saint Petersburg, Россия
        • Chiesi Clinical Trial Site 643758
      • Saratov, Россия
        • Chiesi Clinical Trial Site 643703
      • Saratov, Россия
        • Chiesi Clinical Trial Site 643736
      • Smolensk, Россия
        • Chiesi Clinical Trial Site 643726
      • Stavropol, Россия
        • Chiesi Clinical Trial Site 643740
      • Tomsk, Россия
        • Chiesi Clinical Trial Site 643709
      • Tomsk, Россия
        • Chiesi Clinical Trial Site 643728
      • Tomsk, Россия
        • Chiesi Clinical Trial Site 643759
      • Ufa, Россия
        • Chiesi Clinical Trial Site 643755
      • Vladikavkaz, Россия
        • Chiesi Clinical Trial Site 643708
      • Vladimir, Россия
        • Chiesi Clinical Trial Site 643738
      • Voronezh, Россия
        • Chiesi Clinical Trial Site 643710
      • Yaroslavl, Россия
        • Chiesi Clinical Trial Site 643720
      • Yaroslavl, Россия
        • Chiesi Clinical Trial Site 643734
      • Yaroslavl, Россия
        • Chiesi Clinical Trial Site 643742
      • Yaroslavl, Россия
        • Chiesi Clinical Trial Site 643749
      • Yekaterinburg, Россия
        • Chiesi Clinical Trial Site 643721
  • Румыния
      • Alexandru cel Bun, Румыния
        • Chiesi Clinical Trial Site 642715
      • Arad, Румыния
        • Chiesi Clinical Trial Site 642713
      • Bacau, Румыния
        • Chiesi Clinical Trial Site 642722
      • Bragadiru, Румыния
        • Chiesi Clinical Trial Site 642717
      • Brasov, Румыния
        • Chiesi Clinical Trial Site 642706
      • Bucharest, Румыния
        • Chiesi Clinical Trial Site 642703
      • Bucharest, Румыния
        • Chiesi Clinical Trial Site 642707
      • Bucharest, Румыния
        • Chiesi Clinical Trial Site 642708
      • Bucharest, Румыния
        • Chiesi Clinical Trial Site 642719
      • Bucharest, Румыния
        • Chiesi Clinical Trial Site 642723
      • Cluj-Napoca, Румыния
        • Chiesi Clinical Trial Site 642709
      • Cluj-Napoca, Румыния
        • Chiesi Clinical Trial Site 642714
      • Cluj-Napoca, Румыния
        • Chiesi Clinical Trial Site 642716
      • Cluj-Napoca, Румыния
        • Chiesi Clinical Trial Site 642718
      • Cluj-Napoca, Румыния
        • Chiesi Clinical Trial Site 642726
      • Craiova, Румыния
        • Chiesi Clinical Trial Site 642712
      • Iași, Румыния
        • Chiesi Clinical Trial Site 642704
      • Iași, Румыния
        • Chiesi Clinical Trial Site 642710
      • Oradea, Румыния
        • Chiesi Clinical Trial Site 642705
      • Suceava, Румыния
        • Chiesi Clinical Trial Site 642711
      • Timișoara, Румыния
        • Chiesi Clinical Trial Site 642721
  • Словакия
      • Bratislava, Словакия
        • Chiesi Clinical Trial Site 703704
      • Bratislava, Словакия
        • Chiesi Clinical Trial Site 703707
      • Ilava, Словакия
        • Chiesi Clinical Trial Site 703702
      • Košice, Словакия
        • Chiesi Clinical Trial Site 703705
      • Košice, Словакия
        • Chiesi Clinical Trial Site 703706
      • Nové Zámky, Словакия
        • Chiesi Clinical Trial Site 703701
      • Prievidza, Словакия
        • Chiesi Clinical Trial Site 703709
      • Spišská Nová Ves, Словакия
        • Chiesi Clinical Trial Site 703703
      • Štúrovo, Словакия
        • Chiesi Clinical Trial Site 703708
  • Соединенное Королевство
      • Llanelli, Соединенное Королевство
        • Chiesi Clinical Trial Site 826702
      • London, Соединенное Королевство
        • Chiesi Clinical Trial Site 826703
      • Manchester, Соединенное Королевство
        • Chiesi Clinical Trial Site 826704
      • Soham, Соединенное Королевство
        • Chiesi Clinical Trial Site 826701
  • Турция (Туркие)
      • Ankara, Турция (Туркие)
        • Chiesi Clinical Trial Site 792701
      • Ankara, Турция (Туркие)
        • Chiesi Clinical Trial Site 792702
      • Antalya, Турция (Туркие)
        • Chiesi Clinical Trial Site 792703
      • Aydin, Турция (Туркие)
        • Chiesi Clinical Trial Site 792710
      • Istanbul, Турция (Туркие)
        • Chiesi Clinical Trial Site 792707
      • Kocaeli, Турция (Туркие)
        • Chiesi Clinical Trial Site 792706
      • Maltepe, Турция (Туркие)
        • Chiesi Clinical Trial Site 792705
      • Mersin, Турция (Туркие)
        • Chiesi Clinical Trial Site 792708
      • Yenişehir, Турция (Туркие)
        • Chiesi Clinical Trial Site 792709
  • Украина
      • Dnipro, Украина
        • Chiesi Clinical Trial Site 804701
      • Ivano-Frankivsk, Украина
        • Chiesi Clinical Trial Site 804711
      • Kharkiv, Украина
        • Chiesi Clinical Trial Site 804709
      • Kherson, Украина
        • Chiesi Clinical Trial Site 804710
      • Kiev, Украина
        • Chiesi Clinical Trial Site 804713
      • Kyiv, Украина
        • Chiesi Clinical Trial Site 804705
      • Lviv, Украина
        • Chiesi Clinical Trial Site 804712
      • Sumy, Украина
        • Chiesi Clinical Trial Site 804715
      • Vinnytsia, Украина
        • Chiesi Clinical Trial Site 804703
      • Vinnytsia, Украина
        • Chiesi Clinical Trial Site 804706
      • Vinnytsia, Украина
        • Chiesi Clinical Trial Site 804707
      • Vinnytsia, Украина
        • Chiesi Clinical Trial Site 804714
      • Zaporizhzhya, Украина
        • Chiesi Clinical Trial Site 804704
      • Zhytomyr, Украина
        • Chiesi Clinical Trial Site 804708
  • Чехия
      • Blansko, Чехия
        • Chiesi Clinical Trial Site 203711
      • Brandýs nad Labem, Чехия
        • Chiesi Clinical Trial Site 203702
      • Brno, Чехия
        • Chiesi Clinical Trial Site 203708
      • Jindřichův Hradec, Чехия
        • Chiesi Clinical Trial Site 203707
      • Kralupy nad Vltavou, Чехия
        • Chiesi Clinical Trial Site 203705
      • Miroslav, Чехия
        • Chiesi Clinical Trial Site 203709
      • Opava, Чехия
        • Chiesi Clinical Trial Site 203704
      • Prague, Чехия
        • Chiesi Clinical Trial Site 203701
      • Prague, Чехия
        • Chiesi Clinical Trial Site 203703
      • Prague, Чехия
        • Chiesi Clinical Trial Site 203710
      • Rokycany, Чехия
        • Chiesi Clinical Trial Site 203713
      • Teplice, Чехия
        • Chiesi Clinical Trial Site 203706
      • Varnsdorf, Чехия
        • Chiesi Clinical Trial Site 203712

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 75 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Описание

Критерии включения:

  • История астмы ≥ 1 года и диагноз до 40 лет
  • Неконтролируемая астма с двойной терапией только высокими дозами ингаляционных кортикостероидов (ICS) в сочетании с бета2-агонистом длительного действия (LABA) с ACQ-7 (опросник контроля астмы) ≥1,5
  • ОФВ1 до бронходилататора <80% от прогнозируемого нормального значения
  • Положительный тест на обратимость
  • По крайней мере, 1 документально подтвержденное обострение астмы в течение предыдущего года.

Критерий исключения:

  • Беременные или кормящие женщины
  • Диагностика хронической обструктивной болезни легких (ХОБЛ)
  • Пациенты с любым обострением астмы или инфекцией дыхательных путей за 4 недели до скрининга
  • Текущий курильщик или бывший курильщик (>= 10 пачек в год)
  • Любое изменение дозы, графика или состава комбинации ICS + LABA за 4 недели до скрининга

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 5993 швейцарских франка 200/6/12,5 мкг

Лечение А:

5993 швейцарских франка 200/6/12,5 мкг: 2 ингаляции два раза в день Общая суточная доза: 800/24/50 мкг BDP/FF/GB
Лекарство: 5993 швейцарских франка 200/6/12,5 мкг
Активный компаратор: 1535 швейцарских франков 200/6 мкг

Лечение Б:

1535 швейцарских франков 200/6 мкг: 2 ингаляции два раза в день Общая суточная доза: 800/24 ​​мкг BDP/FF
Лекарство: 1535 швейцарских франков 200/6 мкг
Активный компаратор: CHF 1535 200/6 мкг + тиотропий респимат 2,5 мкг

Лечение C (открытая группа):

1535 швейцарских франков 200/6 мкг: 2 ингаляции два раза в день

+ Тиотропий Респимат 2,5 мкг: 2 ингаляции 1 раз в сутки Общая суточная доза: 800/24 ​​мкг BDP/FF + 5 мкг Тио
Лекарство: CHF 1535 200/6 мкг + тиотропий респимат 2,5 мкг

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26.

Change from baseline in pre-dose FEV1, analysed at Week 26 of treatment.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 26.
2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.

Asthma exacerbation intensity: Moderate AND Severe Asthma Exacerbation

Severe: asthma worsening requiring initiation of treatment with systemic corticosteroids for at least 3 days (courses of corticosteroids separated by ≥1 week treated as separate severe exacerbations).

Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:

  • Nocturnal awakening(s) due to asthma requiring SABA for 2 consecutive nights/increase of ≥ 0.75 from baseline in daily symptom score on 2 consecutive days; increase from baseline in occasions of SABA use on 2 consecutive days (minimum increase 4 puffs/day);
  • ≥20% decrease in peak expiratory flow from baseline on at least 2 consecutive mornings/evenings or ≥ 20% decrease in FEV1 from baseline;
  • Visit to the ER/trial site for asthma treatment not requiring systemic corticosteroid;
Week 0 (pre-treatment, baseline) to Week 52.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
3_Change From Baseline in Peak(0-3h) FEV1 at Week 26
Временное ограничение: Week 0 (pre-treatment, baseline) and Week 26.

Peak peak of forced expiratory volume in the first second (FEV1) within 3 hours post-dose.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) and Week 26.
4_Change From Baseline in Morning Peak Expiratory Flow (PEF) Over the 26-Week Treatment
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26.

Change from baseline in the average morning PEF (Litre/min), measured by patients at home over the 26-week treatment period (i.e., up to Week 26).

PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 26.
5_Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period - Pooled Analysis
Временное ограничение: The entire treatment period; up to Week 52.

Severe asthma exacerbation rate over the 52-Week treatment period in a pre-specified pooled analysis of 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
The entire treatment period; up to Week 52.
6_Change From Baseline in Peak FEV1 (0-3h) at All Clinical Visits
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.

The peak (0-3h) FEV1 at baseline and at all subsequent visits, and the respective changes from baseline are presented by treatment group for all clinical visits.

Baseline for pre-dose FEV1 was calculated as average of the FEV1 measurements (L) from the visit 2 (V2) Pre45min & V2 Pre15min. If one of the two pre-dose values was missing, the baseline was equal to the available pre-dose value.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 52.
7_Change From Baseline in Pre-Dose FEV1 at All Clinical Visits
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in pre-dose FEV1 at all clinical visits.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 52.
8_FEV1 Response (FEV1 ≥ 100 mL) at Week 26 and Week 52
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Results show the percentage of patients classified as FEV1 responders at Week 26 and at Week 52.

The FEV1 response was defined as: Change from baseline in pre-dose morning FEV1 ≥ 100 mL.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
9_Change From Baseline in FEV1 Area Under the Curve (AUC) (0-3h) Normalised by Time at All Clinical Visits
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.

Baseline definition: mean of two pre-dose FEV1 measurements at visit 2 (V2).

Results show the change from baseline in FEV1 area under the curve [AUC] (0-3h) at all subsequent visits (i.e. change from baseline of the AUC of the serial post-dose spirometry assessments till 3h post-dose).

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 52.
10_Change From Baseline in the Asthma Control Questionnaire-7 (ACQ-7) Score at All Clinical Visits
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.

ACQ-7 Questionnaire.

ACQ-7 allows assessment of asthma control in individual patients.

The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on lung function (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control (no impairment) and 6 indicating poor control (maximum impairment). The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer.

Baseline for ACQ-7 was the total score recorded at Visit 2 (Week 0) of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. A negative change from baseline indicates improvement in lung function.
Week 0 (pre-treatment, baseline) to Week 52.
11_Asthma Control Questionnaire©-7 Response at Week 26 and Week 52
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Asthma Control Questionnaire (ACQ) and Asthma Control Questionnaire-7 (QAC-7) are defined in the description of Outcome measure 10 above.

An ACQ-7 response was defined as change from baseline (Week 0, pre-dose) in ACQ-7 score ≤ -0.5; non-response was defined as change from baseline in ACQ-7 score >-0.5 or missing data.

Results represent responders (i.e. change from baseline in ACQ-7 Score ≤ -0.5) at Week 26 and at Week 52.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
12_Change From Baseline in Average Morning PEF (L/Min) Over 52 Weeks of Treatment
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.

Change from baseline in average MORNING PEF (L/min) over 52 weeks of treatment.

PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 52.
12a_Change From Baseline in Average Evening PEF (L/Min) Over 26 and 52 Weeks of Treatment
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in average EVENING PEF (L/min) over 26 and 52 weeks of treatment.

PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
13_Number of Patients at Risk of Moderate or Severe Asthma Exacerbation Over 52 Weeks
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.

Number of patients at risk of a moderate or severe asthma exacerbation.

Results show the number of patients who had moderate or severe asthma exacerbation over the 52 weeks treatment period.
Week 0 (pre-treatment, baseline) to Week 52.
14_Number of Patients at Risk of Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Временное ограничение: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Number of patients at risk of a SEVERE asthma exacerbation in the pooled analysis of the two pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER), over the 52 weeks treatment period.

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
15_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02.
Временное ограничение: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

MODERATE asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-055993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
16_Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Временное ограничение: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02.

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
17_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02
Временное ограничение: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Moderate AND severe asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
18_Number of Patients at Risk of Moderate OR Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Временное ограничение: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Time to first MODERATE OR SEVERE asthma exacerbation in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
19_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.

MODERATE asthma exacerbation rate over the 52-Week treatment period.

Asthma exacerbation intensity: Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:

  • Nocturnal awakening(s) due to asthma requiring SABA for 2 consecutive nights/increase of ≥ 0.75 from baseline in daily symptom score on 2 consecutive days; increase from baseline in occasions of SABA use on 2 consecutive days (minimum increase 4 puffs/day);
  • ≥20% decrease in peak expiratory flow from baseline on at least 2 consecutive mornings/evenings or ≥ 20% decrease in FEV1 from baseline;
  • Visit to the ER/trial site for asthma treatment not requiring systemic corticosteroid;
Week 0 (pre-treatment, baseline) to Week 52.
20_Number of Patients at Risk of a MODERATE Asthma Exacerbation
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
Data were analysed for the number of patients at risk of a MODERATE asthma exacerbation.
Week 0 (pre-treatment, baseline) to Week 52.
21_Change From Baseline in the Average Use of Rescue Medication Over the 26- and 52-Week Treatment Periods
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in the average use of rescue medication over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
21a_Change From Baseline in the Average Use of Rescue Medication in Each Inter-Visit Period
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the average use (puffs/day) of rescue medication in each inter-visit period.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 52.
22_Change From Baseline in the Percentage of Rescue Medication-Free Days Over the 26- and 52-Week Treatment Periods
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in the percentage of rescue medication-free days over the 26- and 52-Week treatment periods.

Data was collected using an electronic daily diary, from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
22a_Change From Baseline in the Percentage of Rescue Medication-Free Days in Each Inter-Visit Period Over the Treatment
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the percentage of rescue medication-free days in each inter-visit period over the entire treatment.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 52.
23_Change From Baseline in the Average Total Daily Asthma Symptom Scores Over the 26- and 52-Week Treatment Periods
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Results show the change from baseline in the average total daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered: cough, wheeze, chest tightness, breathlessness.

Morning (night-time asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Symptoms not causing awakening;
  • 2 Moderate = Discomfort enough to cause awakenings;
  • 3 Severe = Causing awakenings for most of the night/did not sleep at all.

Evening (daytime asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Aware of symptoms, which could be easily tolerated;
  • 2 Moderate = Discomfort enough to cause interference with daily activity;
  • 3 Severe = Incapacitating
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
23a_Change From Baseline in the Average Daily Asthma Symptom Scores in Each Inter-Visit Period
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the average total daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered: cough, wheeze, chest tightness, breathlessness.

Morning (night-time asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Symptoms not causing awakening;
  • 2 Moderate = Discomfort enough to cause awakenings;
  • 3 Severe = Causing awakenings for most of the night/did not sleep at all.

Evening (daytime asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Aware of symptoms, which could be easily tolerated;
  • 2 Moderate = Discomfort enough to cause interference with daily activity;
  • 3 Severe = Incapacitating
Week 0 (pre-treatment, baseline) to Week 52.
24_Change From Baseline in the Percentage of Asthma Symptom-Free Days Over the 26- and 52-Week Treatment Periods
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in the percentage of asthma symptom-free days over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.

Results show the change from baseline in the average daily asthma symptom scores over the 26- and 52-Week treatment periods. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness.

An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
24a_Change From Baseline in the Percentage of Asthma Symptom-Free Days in Each Inter-Visit Periods
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the percentage of asthma symptom-free days in each inter-visit periods over the entire treatment.

Data was collected through an electronic daily diary from screening to end of the study.

A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness.

An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23.
Week 0 (pre-treatment, baseline) to Week 52.
25_Change From Baseline in the Percentage of Asthma Control Days Over the 26- and 52-Week Treatment Periods
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Results show the change from baseline in the percentage of asthma control days over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.

Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness):

Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all).

Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/take part in usual activity).
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
25a_Change From Baseline in the Percentage of Asthma Control Days in Each Inter-Visit Period
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.

A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Data was collected through an electronic daily diary from screening to the end of the study.

Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness):

Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all).

Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/ take part in usual activity).
Week 0 (pre-treatment, baseline) to Week 52.

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Побочные явления и нежелательные реакции на лекарства
Временное ограничение: До 52 недели
До 52 недели
Сборник результатов экономики здравоохранения
Временное ограничение: С 0 по 52 неделю
Общее использование ресурсов здравоохранения и отсутствие на работе
С 0 по 52 неделю

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Chiesi Farmaceutici S.p.A.

Следователи

  • Главный следователь: Georgio Walter Canonica, MD, University of Medicine, Genoa, Italy

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

6 апреля 2016 г.

Первичное завершение (Действительный)

28 мая 2018 г.

Завершение исследования (Действительный)

28 мая 2018 г.

Даты регистрации исследования

Первый отправленный

3 февраля 2016 г.

Впервые представлено, что соответствует критериям контроля качества

3 февраля 2016 г.

Первый опубликованный (Оцененный)

8 февраля 2016 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

26 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CCD-05993AB2-02
  • 2015-000717-40 (Номер EudraCT)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Chiesi обязуется делиться с квалифицированными научными и медицинскими исследователями, проводя законные исследования, данными на уровне пациента, данными на уровне исследования, клиническим протоколом и полной CSR, предоставляя доступ к информации о клинических испытаниях в соответствии с принципом защиты коммерческой конфиденциальной информации и пациентов. Конфиденциальность. Любые передаваемые данные на уровне пациента обезличиваются для защиты информации, позволяющей установить личность.

Критерии доступа Chiesi и полный процесс обмена клиническими данными доступны на веб-сайте Chiesi Group.

Сроки обмена IPD

See information above in Plan Description regarding Chiesi's commitment to share information with qualified scientific and medical researchers, conducting legitimate research

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

Критерии совместного доступа к IPD

Критерии доступа Chiesi и полный процесс обмена клиническими данными доступны на веб-сайте Chiesi Group.

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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