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Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

9 февраля 2015 г. обновлено: Boehringer Ingelheim

A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy

This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

2488

Фаза

  • Фаза 4

Контакты и местонахождение

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

Места учебы

  • Австралия
    • New South Wales
      • Concord, New South Wales, Австралия
        • 352.2046.61006 Boehringer Ingelheim Investigational Site
      • Glebe, New South Wales, Австралия
        • 352.2046.61001 Boehringer Ingelheim Investigational Site
      • Westmead, New South Wales, Австралия
        • 352.2046.61002 Boehringer Ingelheim Investigational Site
    • South Australia
      • Daw Park, South Australia, Австралия
        • 352.2046.61004 Boehringer Ingelheim Investigational Site
      • Toorak Gardens, South Australia, Австралия
        • 352.2046.61003 Boehringer Ingelheim Investigational Site
      • Woodville, South Australia, Австралия
        • 352.2046.61005 Boehringer Ingelheim Investigational Site
  • Бельгия
      • Bruxelles, Бельгия
        • 352.2046.32002 Boehringer Ingelheim Investigational Site
      • Bruxelles, Бельгия
        • 352.2046.32016 Boehringer Ingelheim Investigational Site
      • Eupen, Бельгия
        • 352.2046.32015 Boehringer Ingelheim Investigational Site
      • Gilly, Бельгия
        • 352.2046.32017 Boehringer Ingelheim Investigational Site
      • Herentals, Бельгия
        • 352.2046.32014 Boehringer Ingelheim Investigational Site
      • Jambes, Бельгия
        • 352.2046.32006 Boehringer Ingelheim Investigational Site
      • Lebbeke, Бельгия
        • 352.2046.32008 Boehringer Ingelheim Investigational Site
      • Leuven, Бельгия
        • 352.2046.32001 Boehringer Ingelheim Investigational Site
      • Middelheim, Бельгия
        • 352.2046.32004 Boehringer Ingelheim Investigational Site
      • Montigny-le-Tilleul, Бельгия
        • 352.2046.32010 Boehringer Ingelheim Investigational Site
      • Turnhout, Бельгия
        • 352.2046.32013 Boehringer Ingelheim Investigational Site
  • Болгария
      • Bourgas, Болгария
        • 352.2046.35905 Boehringer Ingelheim Investigational Site
      • Rousse, Болгария
        • 352.2046.35902 Boehringer Ingelheim Investigational Site
      • Sofia, Болгария
        • 352.2046.35904 Boehringer Ingelheim Investigational Site
      • Sofia, Болгария
        • 352.2046.35906 Boehringer Ingelheim Investigational Site
      • Sofia, Болгария
        • 352.2046.35907 Boehringer Ingelheim Investigational Site
      • Sofia, Болгария
        • 352.2046.35908 Boehringer Ingelheim Investigational Site
      • Stara Zagora, Болгария
        • 352.2046.35903 Boehringer Ingelheim Investigational Site
      • Veliko Tarnovo, Болгария
        • 352.2046.35909 Boehringer Ingelheim Investigational Site
  • Бразилия
      • Goiania, Бразилия
        • 352.2046.55005 Boehringer Ingelheim Investigational Site
      • Goiânia, Бразилия
        • 352.2046.55002 Boehringer Ingelheim Investigational Site
      • Porto Alegre, Бразилия
        • 352.2046.55001 Boehringer Ingelheim Investigational Site
      • Porto Alegre, Бразилия
        • 352.2046.55006 Boehringer Ingelheim Investigational Site
      • Sao Paulo, Бразилия
        • 352.2046.55003 Boehringer Ingelheim Investigational Site
  • Венгрия
      • Cegled, Венгрия
        • 352.2046.36003 Boehringer Ingelheim Investigational Site
      • Deszk, Венгрия
        • 352.2046.36002 Boehringer Ingelheim Investigational Site
      • Komarom, Венгрия
        • 352.2046.36004 Boehringer Ingelheim Investigational Site
      • Pecs, Венгрия
        • 352.2046.36006 Boehringer Ingelheim Investigational Site
      • Szarvas, Венгрия
        • 352.2046.36001 Boehringer Ingelheim Investigational Site
      • Szazhalombatta, Венгрия
        • 352.2046.36005 Boehringer Ingelheim Investigational Site
      • Szigetszentmiklos, Венгрия
        • 352.2046.36011 Boehringer Ingelheim Investigational Site
  • Германия
      • Berlin, Германия
        • 352.2046.49012 Boehringer Ingelheim Investigational Site
      • Berlin, Германия
        • 352.2046.49020 Boehringer Ingelheim Investigational Site
      • Berlin, Германия
        • 352.2046.49021 Boehringer Ingelheim Investigational Site
      • Bochum, Германия
        • 352.2046.49008 Boehringer Ingelheim Investigational Site
      • Cottbus, Германия
        • 352.2046.49019 Boehringer Ingelheim Investigational Site
      • Donaustauf, Германия
        • 352.2046.49002 Boehringer Ingelheim Investigational Site
      • Frankfurt, Германия
        • 352.2046.49013 Boehringer Ingelheim Investigational Site
      • Frankfurt, Германия
        • 352.2046.49025 Boehringer Ingelheim Investigational Site
      • Frankfurt/Main, Германия
        • 352.2046.49023 Boehringer Ingelheim Investigational Site
      • Geesthacht, Германия
        • 352.2046.49024 Boehringer Ingelheim Investigational Site
      • Gelnhausen, Германия
        • 352.2046.49022 Boehringer Ingelheim Investigational Site
      • Großhansdorf, Германия
        • 352.2046.49001 Boehringer Ingelheim Investigational Site
      • Heidelberg, Германия
        • 352.2046.49006 Boehringer Ingelheim Investigational Site
      • Immenhausen, Германия
        • 352.2046.49014 Boehringer Ingelheim Investigational Site
      • Kiel, Германия
        • 352.2046.49016 Boehringer Ingelheim Investigational Site
      • Köln, Германия
        • 352.2046.49003 Boehringer Ingelheim Investigational Site
      • Mainz, Германия
        • 352.2046.49004 Boehringer Ingelheim Investigational Site
      • Marburg, Германия
        • 352.2046.49005 Boehringer Ingelheim Investigational Site
      • München, Германия
        • 352.2046.49015 Boehringer Ingelheim Investigational Site
  • Греция
      • Athens, Греция
        • 352.2046.30003 Boehringer Ingelheim Investigational Site
      • Athens, Греция
        • 352.2046.30004 Boehringer Ingelheim Investigational Site
      • Athens, Греция
        • 352.2046.30005 Boehringer Ingelheim Investigational Site
      • Athens, Греция
        • 352.2046.30007 Boehringer Ingelheim Investigational Site
      • Athens, Греция
        • 352.2046.30008 Boehringer Ingelheim Investigational Site
      • Athens, Греция
        • 352.2046.30011 Boehringer Ingelheim Investigational Site
      • Athens, Греция
        • 352.2046.30012 Boehringer Ingelheim Investigational Site
      • Heraklion, Греция
        • 352.2046.30006 Boehringer Ingelheim Investigational Site
      • Larisa, Греция
        • 352.2046.30009 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Греция
        • 352.2046.30001 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Греция
        • 352.2046.30002 Boehringer Ingelheim Investigational Site
  • Дания
      • Aarhus C, Дания
        • 352.2046.45001 Boehringer Ingelheim Investigational Site
      • København NV, Дания
        • 352.2046.45003 Boehringer Ingelheim Investigational Site
      • Odense C, Дания
        • 352.2046.45002 Boehringer Ingelheim Investigational Site
  • Испания
      • Badajoz, Испания
        • 352.2046.34008 Boehringer Ingelheim Investigational Site
      • Barakaldo (Bilbao), Испания
        • 352.2046.34002 Boehringer Ingelheim Investigational Site
      • Barcelona, Испания
        • 352.2046.34001 Boehringer Ingelheim Investigational Site
      • Barcelona, Испания
        • 352.2046.34004 Boehringer Ingelheim Investigational Site
      • Hospitalet de Llobregat, Испания
        • 352.2046.34009 Boehringer Ingelheim Investigational Site
      • Palma de Mallorca, Испания
        • 352.2046.34006 Boehringer Ingelheim Investigational Site
      • Pozuelo de Alarcón, Испания
        • 352.2046.34010 Boehringer Ingelheim Investigational Site
      • Salt (Girona), Испания
        • 352.2046.34013 Boehringer Ingelheim Investigational Site
      • Sevilla, Испания
        • 352.2046.34011 Boehringer Ingelheim Investigational Site
  • Италия
      • Catania, Италия
        • 352.2046.39002 Boehringer Ingelheim Investigational Site
      • Cona, Италия
        • 352.2046.39007 Boehringer Ingelheim Investigational Site
      • Foggia, Италия
        • 352.2046.39005 Boehringer Ingelheim Investigational Site
      • Modena, Италия
        • 352.2046.39003 Boehringer Ingelheim Investigational Site
      • Montescano (pv), Италия
        • 352.2046.39006 Boehringer Ingelheim Investigational Site
      • Pisa, Италия
        • 352.2046.39001 Boehringer Ingelheim Investigational Site
      • Sesto S. Giovanni (mi), Италия
        • 352.2046.39004 Boehringer Ingelheim Investigational Site
      • Tradate (va), Италия
        • 352.2046.39008 Boehringer Ingelheim Investigational Site
  • Китай
      • Beijing, Китай
        • 352.2046.86002 Boehringer Ingelheim Investigational Site
      • Beijing, Китай
        • 352.2046.86003 Boehringer Ingelheim Investigational Site
      • Beijing, Китай
        • 352.2046.86006 Boehringer Ingelheim Investigational Site
      • Chongqing, Китай
        • 352.2046.86008 Boehringer Ingelheim Investigational Site
      • Guangzhou, Китай
        • 352.2046.86001 Boehringer Ingelheim Investigational Site
      • Shanghai, Китай
        • 352.2046.86004 Boehringer Ingelheim Investigational Site
      • Shanghai, Китай
        • 352.2046.86005 Boehringer Ingelheim Investigational Site
      • Wuhan, Китай
        • 352.2046.86007 Boehringer Ingelheim Investigational Site
  • Нидерланды
      • Heerlen, Нидерланды
        • 352.2046.31004 Boehringer Ingelheim Investigational Site
      • Leeuwarden, Нидерланды
        • 352.2046.31001 Boehringer Ingelheim Investigational Site
      • Rotterdam, Нидерланды
        • 352.2046.31003 Boehringer Ingelheim Investigational Site
      • Veldhoven, Нидерланды
        • 352.2046.31002 Boehringer Ingelheim Investigational Site
  • Новая Зеландия
      • Auckland NZ, Новая Зеландия
        • 352.2046.64007 Boehringer Ingelheim Investigational Site
      • Christchurch, Новая Зеландия
        • 352.2046.64003 Boehringer Ingelheim Investigational Site
      • Dunedin, Новая Зеландия
        • 352.2046.64004 Boehringer Ingelheim Investigational Site
      • Hamilton, Новая Зеландия
        • 352.2046.64006 Boehringer Ingelheim Investigational Site
      • Newtown Wellington NZ, Новая Зеландия
        • 352.2046.64001 Boehringer Ingelheim Investigational Site
      • Otahuhu New Zealand, Новая Зеландия
        • 352.2046.64005 Boehringer Ingelheim Investigational Site
      • Tauranga, Новая Зеландия
        • 352.2046.64002 Boehringer Ingelheim Investigational Site
  • Польша
      • Bytom, Польша
        • 352.2046.48006 Boehringer Ingelheim Investigational Site
      • Ostrow Wielkopolska, Польша
        • 352.2046.48003 Boehringer Ingelheim Investigational Site
      • Poznan, Польша
        • 352.2046.48001 Boehringer Ingelheim Investigational Site
      • Poznan, Польша
        • 352.2046.48002 Boehringer Ingelheim Investigational Site
      • Rzeszow, Польша
        • 352.2046.48009 Boehringer Ingelheim Investigational Site
      • Tarnowskie Gory, Польша
        • 352.2046.48011 Boehringer Ingelheim Investigational Site
      • Warsaw, Польша
        • 352.2046.48005 Boehringer Ingelheim Investigational Site
      • Wroclaw, Польша
        • 352.2046.48007 Boehringer Ingelheim Investigational Site
  • Российская Федерация
      • Ekaterinburg, Российская Федерация
        • 352.2046.07011 Boehringer Ingelheim Investigational Site
      • Ivanovo, Российская Федерация
        • 352.2046.07006 Boehringer Ingelheim Investigational Site
      • Moscow, Российская Федерация
        • 352.2046.07008 Boehringer Ingelheim Investigational Site
      • Moscow, Российская Федерация
        • 352.2046.07009 Boehringer Ingelheim Investigational Site
      • Samara, Российская Федерация
        • 352.2046.07002 Boehringer Ingelheim Investigational Site
      • Saratov, Российская Федерация
        • 352.2046.07003 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Российская Федерация
        • 352.2046.07001 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Российская Федерация
        • 352.2046.07004 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Российская Федерация
        • 352.2046.07005 Boehringer Ingelheim Investigational Site
  • Соединенное Королевство
      • Baillieston, Glasgow, Соединенное Королевство
        • 352.2046.44008 Boehringer Ingelheim Investigational Site
      • Barnsley, Соединенное Королевство
        • 352.2046.44009 Boehringer Ingelheim Investigational Site
      • Belfast, Соединенное Королевство
        • 352.2046.44018 Boehringer Ingelheim Investigational Site
      • Birmingham, Соединенное Королевство
        • 352.2046.44010 Boehringer Ingelheim Investigational Site
      • Cambridge, Соединенное Королевство
        • 352.2046.44003 Boehringer Ingelheim Investigational Site
      • Chertsey, Соединенное Королевство
        • 352.2046.44026 Boehringer Ingelheim Investigational Site
      • Chesterfield, Соединенное Королевство
        • 352.2046.44006 Boehringer Ingelheim Investigational Site
      • Cottingham, Hull, Соединенное Королевство
        • 352.2046.44012 Boehringer Ingelheim Investigational Site
      • Inverness, Соединенное Королевство
        • 352.2046.44028 Boehringer Ingelheim Investigational Site
      • Isleworth, Соединенное Королевство
        • 352.2046.44016 Boehringer Ingelheim Investigational Site
      • Liverpool, Соединенное Королевство
        • 352.2046.44002 Boehringer Ingelheim Investigational Site
      • London, Соединенное Королевство
        • 352.2046.44001 Boehringer Ingelheim Investigational Site
      • Norwich, Соединенное Королевство
        • 352.2046.44017 Boehringer Ingelheim Investigational Site
      • Sheffield, Соединенное Королевство
        • 352.2046.44021 Boehringer Ingelheim Investigational Site
      • Sunderland, Соединенное Королевство
        • 352.2046.44019 Boehringer Ingelheim Investigational Site
      • Windsor, Соединенное Королевство
        • 352.2046.44025 Boehringer Ingelheim Investigational Site
  • Тайвань
      • Kaohsiung, Тайвань
        • 352.2046.88606 Boehringer Ingelheim Investigational Site
      • Taichung, Тайвань
        • 352.2046.88604 Boehringer Ingelheim Investigational Site
      • Taipei, Тайвань
        • 352.2046.88601 Boehringer Ingelheim Investigational Site
      • Taipei, Тайвань
        • 352.2046.88603 Boehringer Ingelheim Investigational Site
      • Taiwan, Тайвань
        • 352.2046.88607 Boehringer Ingelheim Investigational Site
      • Taiwan, Тайвань
        • 352.2046.88608 Boehringer Ingelheim Investigational Site
  • Тунис
      • Ariana, Тунис
        • 352.2046.2161A Boehringer Ingelheim Investigational Site
      • Ariana, Тунис
        • 352.2046.2162A Boehringer Ingelheim Investigational Site
      • Sfax, Тунис
        • 352.2046.2165A Boehringer Ingelheim Investigational Site
      • Sousse, Тунис
        • 352.2046.2164A Boehringer Ingelheim Investigational Site
      • Tunis, Тунис
        • 352.2046.2163A Boehringer Ingelheim Investigational Site
  • Турция
      • Ankara, Турция
        • 352.2046.90009 Boehringer Ingelheim Investigational Site
      • Ankara, Турция
        • 352.2046.90019 Boehringer Ingelheim Investigational Site
      • Bursa, Турция
        • 352.2046.90016 Boehringer Ingelheim Investigational Site
      • Denizli, Турция
        • 352.2046.90010 Boehringer Ingelheim Investigational Site
      • Istanbul, Турция
        • 352.2046.90003 Boehringer Ingelheim Investigational Site
      • Istanbul, Турция
        • 352.2046.90004 Boehringer Ingelheim Investigational Site
      • Istanbul, Турция
        • 352.2046.90006 Boehringer Ingelheim Investigational Site
      • Istanbul, Турция
        • 352.2046.90008 Boehringer Ingelheim Investigational Site
      • Istanbul, Турция
        • 352.2046.90012 Boehringer Ingelheim Investigational Site
      • Istanbul, Турция
        • 352.2046.90017 Boehringer Ingelheim Investigational Site
      • Izmir, Турция
        • 352.2046.90011 Boehringer Ingelheim Investigational Site
      • Izmir, Турция
        • 352.2046.90014 Boehringer Ingelheim Investigational Site
      • Izmir, Турция
        • 352.2046.90018 Boehringer Ingelheim Investigational Site
      • Izmit, Турция
        • 352.2046.90005 Boehringer Ingelheim Investigational Site
      • Kayseri, Турция
        • 352.2046.90007 Boehringer Ingelheim Investigational Site
      • Mersin, Турция
        • 352.2046.90001 Boehringer Ingelheim Investigational Site
      • Samsun, Турция
        • 352.2046.90002 Boehringer Ingelheim Investigational Site
  • Украина
      • Ivano-Frankivsk, Украина
        • 352.2046.38007 Boehringer Ingelheim Investigational Site
      • Kharkiv, Украина
        • 352.2046.38002 Boehringer Ingelheim Investigational Site
      • Kharkov, Украина
        • 352.2046.38003 Boehringer Ingelheim Investigational Site
      • Kiev, Украина
        • 352.2046.38004 Boehringer Ingelheim Investigational Site
      • Kiev, Украина
        • 352.2046.38006 Boehringer Ingelheim Investigational Site
      • Vinnitsa, Украина
        • 352.2046.38005 Boehringer Ingelheim Investigational Site
      • Vinnytsya, Украина
        • 352.2046.38001 Boehringer Ingelheim Investigational Site
  • Филиппины
      • Caloocan, Филиппины
        • 352.2046.63001 Boehringer Ingelheim Investigational Site
      • Manila, Филиппины
        • 352.2046.63003 Boehringer Ingelheim Investigational Site
      • Manila, Филиппины
        • 352.2046.63004 Boehringer Ingelheim Investigational Site
      • Muntinlupa, Филиппины
        • 352.2046.63009 Boehringer Ingelheim Investigational Site
      • Quezon, Филиппины
        • 352.2046.63005 Boehringer Ingelheim Investigational Site
      • Quezon, Филиппины
        • 352.2046.63007 Boehringer Ingelheim Investigational Site
      • Quezon City, Филиппины
        • 352.2046.63006 Boehringer Ingelheim Investigational Site
      • Quezon City, Филиппины
        • 352.2046.63008 Boehringer Ingelheim Investigational Site
  • Франция
      • Brest, Франция
        • 352.2046.3317A Boehringer Ingelheim Investigational Site
      • Brest, Франция
        • 352.2046.3317B Boehringer Ingelheim Investigational Site
      • Brest, Франция
        • 352.2046.3317C Boehringer Ingelheim Investigational Site
      • Castelnau le Lez, Франция
        • 352.2046.3320A Boehringer Ingelheim Investigational Site
      • Castelnau le Lez, Франция
        • 352.2046.3320B Boehringer Ingelheim Investigational Site
      • Castelnau le Lez, Франция
        • 352.2046.3320C Boehringer Ingelheim Investigational Site
      • Clermont Ferrand cedex 1, Франция
        • 352.2046.3335A Boehringer Ingelheim Investigational Site
      • Forbach, Франция
        • 352.2046.3314A Boehringer Ingelheim Investigational Site
      • Marseille, Франция
        • 352.2046.3333A Boehringer Ingelheim Investigational Site
      • Marseille cedex 20, Франция
        • 352.2046.3301A Boehringer Ingelheim Investigational Site
      • Montpellier, Франция
        • 352.2046.3326A Boehringer Ingelheim Investigational Site
      • Montpellier, Франция
        • 352.2046.3326C Boehringer Ingelheim Investigational Site
      • Nantes, Франция
        • 352.2046.3334A Boehringer Ingelheim Investigational Site
      • Nantes Cedex 1, Франция
        • 352.2046.3325A Boehringer Ingelheim Investigational Site
      • Nantes Cedex 1, Франция
        • 352.2046.3325C Boehringer Ingelheim Investigational Site
      • Nantes Cedex 1, Франция
        • 352.2046.3325D Boehringer Ingelheim Investigational Site
      • Nîmes, Франция
        • 352.2046.3324A Boehringer Ingelheim Investigational Site
      • Nîmes, Франция
        • 352.2046.3332A Boehringer Ingelheim Investigational Site
      • Nîmes, Франция
        • 352.2046.3332B Boehringer Ingelheim Investigational Site
      • Nîmes, Франция
        • 352.2046.3332C Boehringer Ingelheim Investigational Site
      • Perpignan, Франция
        • 352.2046.3331A Boehringer Ingelheim Investigational Site
      • Perpignan, Франция
        • 352.2046.3331B Boehringer Ingelheim Investigational Site
      • Perpignan, Франция
        • 352.2046.3331C Boehringer Ingelheim Investigational Site
      • Saint Laurent du Var, Франция
        • 352.2046.3329A Boehringer Ingelheim Investigational Site
      • Saint Laurent du Var, Франция
        • 352.2046.3329B Boehringer Ingelheim Investigational Site
      • Saint-Pierre cedex, Франция
        • 352.2046.3302A Boehringer Ingelheim Investigational Site
      • Saint-Pierre cedex, Франция
        • 352.2046.3302B Boehringer Ingelheim Investigational Site
      • Saint-Pierre cedex, Франция
        • 352.2046.3302C Boehringer Ingelheim Investigational Site
      • Saint-Pierre cedex, Франция
        • 352.2046.3302D Boehringer Ingelheim Investigational Site
      • Toulouse, Франция
        • 352.2046.3337A Boehringer Ingelheim Investigational Site
      • Toulouse cedex 9, Франция
        • 352.2046.3336A Boehringer Ingelheim Investigational Site
      • Toulouse cedex 9, Франция
        • 352.2046.3336B Boehringer Ingelheim Investigational Site
      • Toulouse cedex 9, Франция
        • 352.2046.3336C Boehringer Ingelheim Investigational Site
  • Южная Африка
      • Amanzimtoti, Южная Африка
        • 352.2046.27006 Boehringer Ingelheim Investigational Site
      • Bellville, Южная Африка
        • 352.2046.27002 Boehringer Ingelheim Investigational Site
      • Cape Town, Южная Африка
        • 352.2046.27001 Boehringer Ingelheim Investigational Site
      • Cape Town, Южная Африка
        • 352.2046.27003 Boehringer Ingelheim Investigational Site
      • Pretoria, Южная Африка
        • 352.2046.27007 Boehringer Ingelheim Investigational Site
      • Somerset West, Южная Африка
        • 352.2046.27005 Boehringer Ingelheim Investigational Site
      • Tygerberg, Южная Африка
        • 352.2046.27004 Boehringer Ingelheim Investigational Site

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

40 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion criteria:

  1. Male or female aged 40 years or more
  2. Severe to very severe chronic obstructive pulmonary disease (COPD)
  3. Current or ex-smoker with smoking history of at least 10 pack years
  4. At least one documented exacerbation of COPD in previous year

Exclusion criteria:

  1. Significant diseases other than COPD; significant alcohol or drug abuse
  2. Current clinical diagnosis of asthma requiring steroid treatment
  3. History of thoracotomy with pulmonary resection
  4. Regular use of daytime oxygen
  5. Recent history (within 3 months) of myocardial infarction
  6. Recent (within 6 weeks) respiratory infection or COPD exacerbation
  7. Recent (within 6 weeks) treatment with systemic corticosteroids at doses in excess of 5milligram / day
  8. Recent (within 3 months) unstable or life-threatening cardiac arrhythmia requiring intervention
  9. Recent (within 1 year) hospitalisation for cardiac failure
  10. Malignancy requiring chemotherapy or radiotherapy
  11. Clinical diagnosis of bronchiectasis
  12. Pregnant or nursing women
  13. Known hypersensitivity to study drugs
  14. Current or recent (within 30 days) participation in another clinical study
  15. Current participation in or recent completion (within 4 weeks) of a pulmonary rehabilitation program

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: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: fluticasone high dose
fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate
Лекарство: salmeterol xinafoate
Лекарство: флутиказона пропионат
Лекарство: tiotropium inhalation
Экспериментальный: fluticasone medium & low doses
fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
Лекарство: salmeterol xinafoate
Лекарство: флутиказона пропионат
Лекарство: tiotropium inhalation
Лекарство: placebo matched for fluticasone propionate

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Time to First Moderate or Severe On-treatment COPD Exacerbation
Временное ограничение: During randomised treatment, up to 488 days
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval.
During randomised treatment, up to 488 days

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Moderate or Severe On-treatment COPD Exacerbations
Временное ограничение: During randomised treatment, up to 488 days

Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.

Measured values show adjusted mean event rate.
During randomised treatment, up to 488 days
Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation
Временное ограничение: During randomised treatment, up to 488 days
Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.
During randomised treatment, up to 488 days
Time to First Severe On-treatment COPD Exacerbation
Временное ограничение: During randomised treatment, up to 488 days

Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.

The "measure type" displays the 25th percentile and its 95% confidence interval.
During randomised treatment, up to 488 days
Number of Severe On-treatment COPD Exacerbations
Временное ограничение: During randomised treatment, up to 488 days

Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.

Measured values show adjusted event rate.
During randomised treatment, up to 488 days
Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.
Временное ограничение: During randomised treatment, up to 488 days
Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.
During randomised treatment, up to 488 days
Time to First On-treatment COPD Exacerbation
Временное ограничение: During randomised treatment, up to 488 days
Time to first on-treatment COPD exacerbation of any severity. The "measure type" displays the 25th percentile and its 95% confidence interval.
During randomised treatment, up to 488 days
Number of On-treatment COPD Exacerbations
Временное ограничение: During randomised treatment, up to 488 days

Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined.

Measured values show adjusted event rate.
During randomised treatment, up to 488 days
Proportion of Patients With at Least One On-treatment COPD Exacerbation
Временное ограничение: During randomised treatment, up to 488 days
Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage.
During randomised treatment, up to 488 days
Severity of On-treatment COPD Exacerbations
Временное ограничение: During randomised treatment, up to 488 days
Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe)
During randomised treatment, up to 488 days
Change in On-treatment Lung Function as Measured by Trough FEV1
Временное ограничение: Baseline and week 6, 12, 18 and 52 visits
Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 6, 12, 18 and 52 visits
Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale
Временное ограничение: Baseline and week 18 and 52 visits

Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health.

Scale from 0 to 4:

  • 0 = not troubled by breathlessness, except during strenuous exercise
  • 1 = short of breath when hurrying or walking up a slight hill
  • 2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace
  • 3 = stops for breath after approximately 100 yards, or after a few minutes on the level
  • 4 = too breathless to leave the house, or breathless when dressing or undressing

"No breathlessness" was given a score of -1

Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 18 and 52 visits
Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)
Временное ограничение: Baseline and week 18 and 52 visits
Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 18 and 52 visits
Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)
Временное ограничение: Baseline and week 18 and 52 visits
Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 18 and 52 visits
Change in On-treatment BODE Index
Временное ограничение: Baseline and week 18 and 52 visits
Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain
Временное ограничение: Baseline and week 12, 18 and 52 visits

Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough.

Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 12, 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain
Временное ограничение: Baseline and week 12, 18 and 52 visits

Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough.

Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 12, 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain
Временное ограничение: Baseline and week 12, 18 and 52 visits

Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum.

Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 12, 18 and 52 visits
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain
Временное ограничение: Baseline and week 12, 18 and 52 visits

Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum.

Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 12, 18 and 52 visits
Change in On-treatment FEV1 as Measured by Home Based Spirometry
Временное ограничение: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change in On-treatment FVC as Measured by Home Based Spirometry
Временное ограничение: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change in On-treatment PEFR as Measured by Home Based Spirometry
Временное ограничение: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain
Временное ограничение: Baseline and week 27 and 52 visits

Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.

Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 27 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain
Временное ограничение: Baseline and week 27 and 52 visits

Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.

Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 27 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain
Временное ограничение: Baseline and week 27 and 52 visits

Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.

Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 27 and 52 visits
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score
Временное ограничение: Baseline and week 27 and 52 visits

Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.

Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 27 and 52 visits
Change in On-treatment Physician Global Evaluation
Временное ограничение: Baseline and week 27 and 52 visits

Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score.

Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Baseline and week 27 and 52 visits

Соавторы и исследователи

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

Спонсор

Boehringer Ingelheim

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

1 февраля 2009 г.

Первичное завершение (Действительный)

1 июля 2013 г.

Завершение исследования (Действительный)

1 июля 2013 г.

Даты регистрации исследования

Первый отправленный

10 сентября 2009 г.

Впервые представлено, что соответствует критериям контроля качества

10 сентября 2009 г.

Первый опубликованный (Оценивать)

11 сентября 2009 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

10 февраля 2015 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

9 февраля 2015 г.

Последняя проверка

1 февраля 2015 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 352.2046
  • 2007-002522-29 (Номер EudraCT: EudraCT)

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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