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Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

9. februar 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

2488

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: fluticasone high dose
fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate
Legemiddel: salmeterol xinafoate
Legemiddel: flutikasonpropionat
Legemiddel: tiotropium inhalation
Eksperimentell: fluticasone medium & low doses
fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
Legemiddel: salmeterol xinafoate
Legemiddel: flutikasonpropionat
Legemiddel: tiotropium inhalation
Legemiddel: placebo matched for fluticasone propionate

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to First Moderate or Severe On-treatment COPD Exacerbation
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Moderate or Severe On-treatment COPD Exacerbations
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

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Studer hoveddatoer

Studiestart

1. februar 2009

Primær fullføring (Faktiske)

1. juli 2013

Studiet fullført (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først innsendt

10. september 2009

Først innsendt som oppfylte QC-kriteriene

10. september 2009

Først lagt ut (Anslag)

11. september 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

10. februar 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. februar 2015

Sist bekreftet

1. februar 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

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