이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

2015년 2월 9일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

2488

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

40년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: fluticasone high dose
fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate
의약품: salmeterol xinafoate
의약품: 플루티카손 프로피오네이트
의약품: tiotropium inhalation
실험적: fluticasone medium & low doses
fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
의약품: salmeterol xinafoate
의약품: 플루티카손 프로피오네이트
의약품: tiotropium inhalation
의약품: placebo matched for fluticasone propionate

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Time to First Moderate or Severe On-treatment COPD Exacerbation
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Moderate or Severe On-treatment COPD Exacerbations
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 2월 1일

기본 완료 (실제)

2013년 7월 1일

연구 완료 (실제)

2013년 7월 1일

연구 등록 날짜

최초 제출

2009년 9월 10일

QC 기준을 충족하는 최초 제출

2009년 9월 10일

처음 게시됨 (추정)

2009년 9월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 2월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 2월 9일

마지막으로 확인됨

2015년 2월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

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

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다