このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

2015年2月9日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

2488

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • イギリス
      • Baillieston, Glasgow、イギリス
        • 352.2046.44008 Boehringer Ingelheim Investigational Site
      • Barnsley、イギリス
        • 352.2046.44009 Boehringer Ingelheim Investigational Site
      • Belfast、イギリス
        • 352.2046.44018 Boehringer Ingelheim Investigational Site
      • Birmingham、イギリス
        • 352.2046.44010 Boehringer Ingelheim Investigational Site
      • Cambridge、イギリス
        • 352.2046.44003 Boehringer Ingelheim Investigational Site
      • Chertsey、イギリス
        • 352.2046.44026 Boehringer Ingelheim Investigational Site
      • Chesterfield、イギリス
        • 352.2046.44006 Boehringer Ingelheim Investigational Site
      • Cottingham, Hull、イギリス
        • 352.2046.44012 Boehringer Ingelheim Investigational Site
      • Inverness、イギリス
        • 352.2046.44028 Boehringer Ingelheim Investigational Site
      • Isleworth、イギリス
        • 352.2046.44016 Boehringer Ingelheim Investigational Site
      • Liverpool、イギリス
        • 352.2046.44002 Boehringer Ingelheim Investigational Site
      • London、イギリス
        • 352.2046.44001 Boehringer Ingelheim Investigational Site
      • Norwich、イギリス
        • 352.2046.44017 Boehringer Ingelheim Investigational Site
      • Sheffield、イギリス
        • 352.2046.44021 Boehringer Ingelheim Investigational Site
      • Sunderland、イギリス
        • 352.2046.44019 Boehringer Ingelheim Investigational Site
      • Windsor、イギリス
        • 352.2046.44025 Boehringer Ingelheim Investigational Site
  • イタリア
      • Catania、イタリア
        • 352.2046.39002 Boehringer Ingelheim Investigational Site
      • Cona、イタリア
        • 352.2046.39007 Boehringer Ingelheim Investigational Site
      • Foggia、イタリア
        • 352.2046.39005 Boehringer Ingelheim Investigational Site
      • Modena、イタリア
        • 352.2046.39003 Boehringer Ingelheim Investigational Site
      • Montescano (pv)、イタリア
        • 352.2046.39006 Boehringer Ingelheim Investigational Site
      • Pisa、イタリア
        • 352.2046.39001 Boehringer Ingelheim Investigational Site
      • Sesto S. Giovanni (mi)、イタリア
        • 352.2046.39004 Boehringer Ingelheim Investigational Site
      • Tradate (va)、イタリア
        • 352.2046.39008 Boehringer Ingelheim Investigational Site
  • ウクライナ
      • Ivano-Frankivsk、ウクライナ
        • 352.2046.38007 Boehringer Ingelheim Investigational Site
      • Kharkiv、ウクライナ
        • 352.2046.38002 Boehringer Ingelheim Investigational Site
      • Kharkov、ウクライナ
        • 352.2046.38003 Boehringer Ingelheim Investigational Site
      • Kiev、ウクライナ
        • 352.2046.38004 Boehringer Ingelheim Investigational Site
      • Kiev、ウクライナ
        • 352.2046.38006 Boehringer Ingelheim Investigational Site
      • Vinnitsa、ウクライナ
        • 352.2046.38005 Boehringer Ingelheim Investigational Site
      • Vinnytsya、ウクライナ
        • 352.2046.38001 Boehringer Ingelheim Investigational Site
  • オランダ
      • Heerlen、オランダ
        • 352.2046.31004 Boehringer Ingelheim Investigational Site
      • Leeuwarden、オランダ
        • 352.2046.31001 Boehringer Ingelheim Investigational Site
      • Rotterdam、オランダ
        • 352.2046.31003 Boehringer Ingelheim Investigational Site
      • Veldhoven、オランダ
        • 352.2046.31002 Boehringer Ingelheim Investigational Site
  • オーストラリア
    • New South Wales
      • Concord、New South Wales、オーストラリア
        • 352.2046.61006 Boehringer Ingelheim Investigational Site
      • Glebe、New South Wales、オーストラリア
        • 352.2046.61001 Boehringer Ingelheim Investigational Site
      • Westmead、New South Wales、オーストラリア
        • 352.2046.61002 Boehringer Ingelheim Investigational Site
    • South Australia
      • Daw Park、South Australia、オーストラリア
        • 352.2046.61004 Boehringer Ingelheim Investigational Site
      • Toorak Gardens、South Australia、オーストラリア
        • 352.2046.61003 Boehringer Ingelheim Investigational Site
      • Woodville、South Australia、オーストラリア
        • 352.2046.61005 Boehringer Ingelheim Investigational Site
  • ギリシャ
      • Athens、ギリシャ
        • 352.2046.30003 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 352.2046.30004 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 352.2046.30005 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 352.2046.30007 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 352.2046.30008 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 352.2046.30011 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 352.2046.30012 Boehringer Ingelheim Investigational Site
      • Heraklion、ギリシャ
        • 352.2046.30006 Boehringer Ingelheim Investigational Site
      • Larisa、ギリシャ
        • 352.2046.30009 Boehringer Ingelheim Investigational Site
      • Thessaloniki、ギリシャ
        • 352.2046.30001 Boehringer Ingelheim Investigational Site
      • Thessaloniki、ギリシャ
        • 352.2046.30002 Boehringer Ingelheim Investigational Site
  • スペイン
      • Badajoz、スペイン
        • 352.2046.34008 Boehringer Ingelheim Investigational Site
      • Barakaldo (Bilbao)、スペイン
        • 352.2046.34002 Boehringer Ingelheim Investigational Site
      • Barcelona、スペイン
        • 352.2046.34001 Boehringer Ingelheim Investigational Site
      • Barcelona、スペイン
        • 352.2046.34004 Boehringer Ingelheim Investigational Site
      • Hospitalet de Llobregat、スペイン
        • 352.2046.34009 Boehringer Ingelheim Investigational Site
      • Palma de Mallorca、スペイン
        • 352.2046.34006 Boehringer Ingelheim Investigational Site
      • Pozuelo de Alarcón、スペイン
        • 352.2046.34010 Boehringer Ingelheim Investigational Site
      • Salt (Girona)、スペイン
        • 352.2046.34013 Boehringer Ingelheim Investigational Site
      • Sevilla、スペイン
        • 352.2046.34011 Boehringer Ingelheim Investigational Site
  • チュニジア
      • Ariana、チュニジア
        • 352.2046.2161A Boehringer Ingelheim Investigational Site
      • Ariana、チュニジア
        • 352.2046.2162A Boehringer Ingelheim Investigational Site
      • Sfax、チュニジア
        • 352.2046.2165A Boehringer Ingelheim Investigational Site
      • Sousse、チュニジア
        • 352.2046.2164A Boehringer Ingelheim Investigational Site
      • Tunis、チュニジア
        • 352.2046.2163A Boehringer Ingelheim Investigational Site
  • デンマーク
      • Aarhus C、デンマーク
        • 352.2046.45001 Boehringer Ingelheim Investigational Site
      • København NV、デンマーク
        • 352.2046.45003 Boehringer Ingelheim Investigational Site
      • Odense C、デンマーク
        • 352.2046.45002 Boehringer Ingelheim Investigational Site
  • ドイツ
      • Berlin、ドイツ
        • 352.2046.49012 Boehringer Ingelheim Investigational Site
      • Berlin、ドイツ
        • 352.2046.49020 Boehringer Ingelheim Investigational Site
      • Berlin、ドイツ
        • 352.2046.49021 Boehringer Ingelheim Investigational Site
      • Bochum、ドイツ
        • 352.2046.49008 Boehringer Ingelheim Investigational Site
      • Cottbus、ドイツ
        • 352.2046.49019 Boehringer Ingelheim Investigational Site
      • Donaustauf、ドイツ
        • 352.2046.49002 Boehringer Ingelheim Investigational Site
      • Frankfurt、ドイツ
        • 352.2046.49013 Boehringer Ingelheim Investigational Site
      • Frankfurt、ドイツ
        • 352.2046.49025 Boehringer Ingelheim Investigational Site
      • Frankfurt/Main、ドイツ
        • 352.2046.49023 Boehringer Ingelheim Investigational Site
      • Geesthacht、ドイツ
        • 352.2046.49024 Boehringer Ingelheim Investigational Site
      • Gelnhausen、ドイツ
        • 352.2046.49022 Boehringer Ingelheim Investigational Site
      • Großhansdorf、ドイツ
        • 352.2046.49001 Boehringer Ingelheim Investigational Site
      • Heidelberg、ドイツ
        • 352.2046.49006 Boehringer Ingelheim Investigational Site
      • Immenhausen、ドイツ
        • 352.2046.49014 Boehringer Ingelheim Investigational Site
      • Kiel、ドイツ
        • 352.2046.49016 Boehringer Ingelheim Investigational Site
      • Köln、ドイツ
        • 352.2046.49003 Boehringer Ingelheim Investigational Site
      • Mainz、ドイツ
        • 352.2046.49004 Boehringer Ingelheim Investigational Site
      • Marburg、ドイツ
        • 352.2046.49005 Boehringer Ingelheim Investigational Site
      • München、ドイツ
        • 352.2046.49015 Boehringer Ingelheim Investigational Site
  • ニュージーランド
      • Auckland NZ、ニュージーランド
        • 352.2046.64007 Boehringer Ingelheim Investigational Site
      • Christchurch、ニュージーランド
        • 352.2046.64003 Boehringer Ingelheim Investigational Site
      • Dunedin、ニュージーランド
        • 352.2046.64004 Boehringer Ingelheim Investigational Site
      • Hamilton、ニュージーランド
        • 352.2046.64006 Boehringer Ingelheim Investigational Site
      • Newtown Wellington NZ、ニュージーランド
        • 352.2046.64001 Boehringer Ingelheim Investigational Site
      • Otahuhu New Zealand、ニュージーランド
        • 352.2046.64005 Boehringer Ingelheim Investigational Site
      • Tauranga、ニュージーランド
        • 352.2046.64002 Boehringer Ingelheim Investigational Site
  • ハンガリー
      • Cegled、ハンガリー
        • 352.2046.36003 Boehringer Ingelheim Investigational Site
      • Deszk、ハンガリー
        • 352.2046.36002 Boehringer Ingelheim Investigational Site
      • Komarom、ハンガリー
        • 352.2046.36004 Boehringer Ingelheim Investigational Site
      • Pecs、ハンガリー
        • 352.2046.36006 Boehringer Ingelheim Investigational Site
      • Szarvas、ハンガリー
        • 352.2046.36001 Boehringer Ingelheim Investigational Site
      • Szazhalombatta、ハンガリー
        • 352.2046.36005 Boehringer Ingelheim Investigational Site
      • Szigetszentmiklos、ハンガリー
        • 352.2046.36011 Boehringer Ingelheim Investigational Site
  • フィリピン
      • Caloocan、フィリピン
        • 352.2046.63001 Boehringer Ingelheim Investigational Site
      • Manila、フィリピン
        • 352.2046.63003 Boehringer Ingelheim Investigational Site
      • Manila、フィリピン
        • 352.2046.63004 Boehringer Ingelheim Investigational Site
      • Muntinlupa、フィリピン
        • 352.2046.63009 Boehringer Ingelheim Investigational Site
      • Quezon、フィリピン
        • 352.2046.63005 Boehringer Ingelheim Investigational Site
      • Quezon、フィリピン
        • 352.2046.63007 Boehringer Ingelheim Investigational Site
      • Quezon City、フィリピン
        • 352.2046.63006 Boehringer Ingelheim Investigational Site
      • Quezon City、フィリピン
        • 352.2046.63008 Boehringer Ingelheim Investigational Site
  • フランス
      • Brest、フランス
        • 352.2046.3317A Boehringer Ingelheim Investigational Site
      • Brest、フランス
        • 352.2046.3317B Boehringer Ingelheim Investigational Site
      • Brest、フランス
        • 352.2046.3317C Boehringer Ingelheim Investigational Site
      • Castelnau le Lez、フランス
        • 352.2046.3320A Boehringer Ingelheim Investigational Site
      • Castelnau le Lez、フランス
        • 352.2046.3320B Boehringer Ingelheim Investigational Site
      • Castelnau le Lez、フランス
        • 352.2046.3320C Boehringer Ingelheim Investigational Site
      • Clermont Ferrand cedex 1、フランス
        • 352.2046.3335A Boehringer Ingelheim Investigational Site
      • Forbach、フランス
        • 352.2046.3314A Boehringer Ingelheim Investigational Site
      • Marseille、フランス
        • 352.2046.3333A Boehringer Ingelheim Investigational Site
      • Marseille cedex 20、フランス
        • 352.2046.3301A Boehringer Ingelheim Investigational Site
      • Montpellier、フランス
        • 352.2046.3326A Boehringer Ingelheim Investigational Site
      • Montpellier、フランス
        • 352.2046.3326C Boehringer Ingelheim Investigational Site
      • Nantes、フランス
        • 352.2046.3334A Boehringer Ingelheim Investigational Site
      • Nantes Cedex 1、フランス
        • 352.2046.3325A Boehringer Ingelheim Investigational Site
      • Nantes Cedex 1、フランス
        • 352.2046.3325C Boehringer Ingelheim Investigational Site
      • Nantes Cedex 1、フランス
        • 352.2046.3325D Boehringer Ingelheim Investigational Site
      • Nîmes、フランス
        • 352.2046.3324A Boehringer Ingelheim Investigational Site
      • Nîmes、フランス
        • 352.2046.3332A Boehringer Ingelheim Investigational Site
      • Nîmes、フランス
        • 352.2046.3332B Boehringer Ingelheim Investigational Site
      • Nîmes、フランス
        • 352.2046.3332C Boehringer Ingelheim Investigational Site
      • Perpignan、フランス
        • 352.2046.3331A Boehringer Ingelheim Investigational Site
      • Perpignan、フランス
        • 352.2046.3331B Boehringer Ingelheim Investigational Site
      • Perpignan、フランス
        • 352.2046.3331C Boehringer Ingelheim Investigational Site
      • Saint Laurent du Var、フランス
        • 352.2046.3329A Boehringer Ingelheim Investigational Site
      • Saint Laurent du Var、フランス
        • 352.2046.3329B Boehringer Ingelheim Investigational Site
      • Saint-Pierre cedex、フランス
        • 352.2046.3302A Boehringer Ingelheim Investigational Site
      • Saint-Pierre cedex、フランス
        • 352.2046.3302B Boehringer Ingelheim Investigational Site
      • Saint-Pierre cedex、フランス
        • 352.2046.3302C Boehringer Ingelheim Investigational Site
      • Saint-Pierre cedex、フランス
        • 352.2046.3302D Boehringer Ingelheim Investigational Site
      • Toulouse、フランス
        • 352.2046.3337A Boehringer Ingelheim Investigational Site
      • Toulouse cedex 9、フランス
        • 352.2046.3336A Boehringer Ingelheim Investigational Site
      • Toulouse cedex 9、フランス
        • 352.2046.3336B Boehringer Ingelheim Investigational Site
      • Toulouse cedex 9、フランス
        • 352.2046.3336C Boehringer Ingelheim Investigational Site
  • ブラジル
      • Goiania、ブラジル
        • 352.2046.55005 Boehringer Ingelheim Investigational Site
      • Goiânia、ブラジル
        • 352.2046.55002 Boehringer Ingelheim Investigational Site
      • Porto Alegre、ブラジル
        • 352.2046.55001 Boehringer Ingelheim Investigational Site
      • Porto Alegre、ブラジル
        • 352.2046.55006 Boehringer Ingelheim Investigational Site
      • Sao Paulo、ブラジル
        • 352.2046.55003 Boehringer Ingelheim Investigational Site
  • ブルガリア
      • Bourgas、ブルガリア
        • 352.2046.35905 Boehringer Ingelheim Investigational Site
      • Rousse、ブルガリア
        • 352.2046.35902 Boehringer Ingelheim Investigational Site
      • Sofia、ブルガリア
        • 352.2046.35904 Boehringer Ingelheim Investigational Site
      • Sofia、ブルガリア
        • 352.2046.35906 Boehringer Ingelheim Investigational Site
      • Sofia、ブルガリア
        • 352.2046.35907 Boehringer Ingelheim Investigational Site
      • Sofia、ブルガリア
        • 352.2046.35908 Boehringer Ingelheim Investigational Site
      • Stara Zagora、ブルガリア
        • 352.2046.35903 Boehringer Ingelheim Investigational Site
      • Veliko Tarnovo、ブルガリア
        • 352.2046.35909 Boehringer Ingelheim Investigational Site
  • ベルギー
      • Bruxelles、ベルギー
        • 352.2046.32002 Boehringer Ingelheim Investigational Site
      • Bruxelles、ベルギー
        • 352.2046.32016 Boehringer Ingelheim Investigational Site
      • Eupen、ベルギー
        • 352.2046.32015 Boehringer Ingelheim Investigational Site
      • Gilly、ベルギー
        • 352.2046.32017 Boehringer Ingelheim Investigational Site
      • Herentals、ベルギー
        • 352.2046.32014 Boehringer Ingelheim Investigational Site
      • Jambes、ベルギー
        • 352.2046.32006 Boehringer Ingelheim Investigational Site
      • Lebbeke、ベルギー
        • 352.2046.32008 Boehringer Ingelheim Investigational Site
      • Leuven、ベルギー
        • 352.2046.32001 Boehringer Ingelheim Investigational Site
      • Middelheim、ベルギー
        • 352.2046.32004 Boehringer Ingelheim Investigational Site
      • Montigny-le-Tilleul、ベルギー
        • 352.2046.32010 Boehringer Ingelheim Investigational Site
      • Turnhout、ベルギー
        • 352.2046.32013 Boehringer Ingelheim Investigational Site
  • ポーランド
      • Bytom、ポーランド
        • 352.2046.48006 Boehringer Ingelheim Investigational Site
      • Ostrow Wielkopolska、ポーランド
        • 352.2046.48003 Boehringer Ingelheim Investigational Site
      • Poznan、ポーランド
        • 352.2046.48001 Boehringer Ingelheim Investigational Site
      • Poznan、ポーランド
        • 352.2046.48002 Boehringer Ingelheim Investigational Site
      • Rzeszow、ポーランド
        • 352.2046.48009 Boehringer Ingelheim Investigational Site
      • Tarnowskie Gory、ポーランド
        • 352.2046.48011 Boehringer Ingelheim Investigational Site
      • Warsaw、ポーランド
        • 352.2046.48005 Boehringer Ingelheim Investigational Site
      • Wroclaw、ポーランド
        • 352.2046.48007 Boehringer Ingelheim Investigational Site
  • ロシア連邦
      • Ekaterinburg、ロシア連邦
        • 352.2046.07011 Boehringer Ingelheim Investigational Site
      • Ivanovo、ロシア連邦
        • 352.2046.07006 Boehringer Ingelheim Investigational Site
      • Moscow、ロシア連邦
        • 352.2046.07008 Boehringer Ingelheim Investigational Site
      • Moscow、ロシア連邦
        • 352.2046.07009 Boehringer Ingelheim Investigational Site
      • Samara、ロシア連邦
        • 352.2046.07002 Boehringer Ingelheim Investigational Site
      • Saratov、ロシア連邦
        • 352.2046.07003 Boehringer Ingelheim Investigational Site
      • St. Petersburg、ロシア連邦
        • 352.2046.07001 Boehringer Ingelheim Investigational Site
      • Yaroslavl、ロシア連邦
        • 352.2046.07004 Boehringer Ingelheim Investigational Site
      • Yaroslavl、ロシア連邦
        • 352.2046.07005 Boehringer Ingelheim Investigational Site
  • 七面鳥
      • Ankara、七面鳥
        • 352.2046.90009 Boehringer Ingelheim Investigational Site
      • Ankara、七面鳥
        • 352.2046.90019 Boehringer Ingelheim Investigational Site
      • Bursa、七面鳥
        • 352.2046.90016 Boehringer Ingelheim Investigational Site
      • Denizli、七面鳥
        • 352.2046.90010 Boehringer Ingelheim Investigational Site
      • Istanbul、七面鳥
        • 352.2046.90003 Boehringer Ingelheim Investigational Site
      • Istanbul、七面鳥
        • 352.2046.90004 Boehringer Ingelheim Investigational Site
      • Istanbul、七面鳥
        • 352.2046.90006 Boehringer Ingelheim Investigational Site
      • Istanbul、七面鳥
        • 352.2046.90008 Boehringer Ingelheim Investigational Site
      • Istanbul、七面鳥
        • 352.2046.90012 Boehringer Ingelheim Investigational Site
      • Istanbul、七面鳥
        • 352.2046.90017 Boehringer Ingelheim Investigational Site
      • Izmir、七面鳥
        • 352.2046.90011 Boehringer Ingelheim Investigational Site
      • Izmir、七面鳥
        • 352.2046.90014 Boehringer Ingelheim Investigational Site
      • Izmir、七面鳥
        • 352.2046.90018 Boehringer Ingelheim Investigational Site
      • Izmit、七面鳥
        • 352.2046.90005 Boehringer Ingelheim Investigational Site
      • Kayseri、七面鳥
        • 352.2046.90007 Boehringer Ingelheim Investigational Site
      • Mersin、七面鳥
        • 352.2046.90001 Boehringer Ingelheim Investigational Site
      • Samsun、七面鳥
        • 352.2046.90002 Boehringer Ingelheim Investigational Site
  • 中国
      • Beijing、中国
        • 352.2046.86002 Boehringer Ingelheim Investigational Site
      • Beijing、中国
        • 352.2046.86003 Boehringer Ingelheim Investigational Site
      • Beijing、中国
        • 352.2046.86006 Boehringer Ingelheim Investigational Site
      • Chongqing、中国
        • 352.2046.86008 Boehringer Ingelheim Investigational Site
      • Guangzhou、中国
        • 352.2046.86001 Boehringer Ingelheim Investigational Site
      • Shanghai、中国
        • 352.2046.86004 Boehringer Ingelheim Investigational Site
      • Shanghai、中国
        • 352.2046.86005 Boehringer Ingelheim Investigational Site
      • Wuhan、中国
        • 352.2046.86007 Boehringer Ingelheim Investigational Site
  • 南アフリカ
      • Amanzimtoti、南アフリカ
        • 352.2046.27006 Boehringer Ingelheim Investigational Site
      • Bellville、南アフリカ
        • 352.2046.27002 Boehringer Ingelheim Investigational Site
      • Cape Town、南アフリカ
        • 352.2046.27001 Boehringer Ingelheim Investigational Site
      • Cape Town、南アフリカ
        • 352.2046.27003 Boehringer Ingelheim Investigational Site
      • Pretoria、南アフリカ
        • 352.2046.27007 Boehringer Ingelheim Investigational Site
      • Somerset West、南アフリカ
        • 352.2046.27005 Boehringer Ingelheim Investigational Site
      • Tygerberg、南アフリカ
        • 352.2046.27004 Boehringer Ingelheim Investigational Site
  • 台湾
      • Kaohsiung、台湾
        • 352.2046.88606 Boehringer Ingelheim Investigational Site
      • Taichung、台湾
        • 352.2046.88604 Boehringer Ingelheim Investigational Site
      • Taipei、台湾
        • 352.2046.88601 Boehringer Ingelheim Investigational Site
      • Taipei、台湾
        • 352.2046.88603 Boehringer Ingelheim Investigational Site
      • Taiwan、台湾
        • 352.2046.88607 Boehringer Ingelheim Investigational Site
      • Taiwan、台湾
        • 352.2046.88608 Boehringer Ingelheim Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

40年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：fluticasone high dose
fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate
薬：salmeterol xinafoate
薬：プロピオン酸フルチカゾン
薬：tiotropium inhalation
実験的：fluticasone medium & low doses
fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
薬：salmeterol xinafoate
薬：プロピオン酸フルチカゾン
薬：tiotropium inhalation
薬：placebo matched for fluticasone propionate

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Time to First Moderate or Severe On-treatment COPD Exacerbation
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Moderate or Severe On-treatment COPD Exacerbations
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Boehringer Ingelheim

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年2月1日

一次修了 (実際)

2013年7月1日

研究の完了 (実際)

2013年7月1日

試験登録日

最初に提出

2009年9月10日

QC基準を満たした最初の提出物

2009年9月10日

最初の投稿 (見積もり)

2009年9月11日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年2月10日

QC基準を満たした最後の更新が送信されました

2015年2月9日

最終確認日

2015年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する