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Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

9. února 2015 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

2488

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

40 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: fluticasone high dose
fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate
Lék: salmeterol xinafoate
Lék: flutikason propionát
Lék: tiotropium inhalation
Experimentální: fluticasone medium & low doses
fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
Lék: salmeterol xinafoate
Lék: flutikason propionát
Lék: tiotropium inhalation
Lék: placebo matched for fluticasone propionate

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to First Moderate or Severe On-treatment COPD Exacerbation
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Moderate or Severe On-treatment COPD Exacerbations
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Boehringer Ingelheim

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. února 2009

Primární dokončení (Aktuální)

1. července 2013

Dokončení studie (Aktuální)

1. července 2013

Termíny zápisu do studia

První předloženo

10. září 2009

První předloženo, které splnilo kritéria kontroly kvality

10. září 2009

První zveřejněno (Odhad)

11. září 2009

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

10. února 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. února 2015

Naposledy ověřeno

1. února 2015

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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