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重度から非常に重度の慢性閉塞性肺疾患患者における中等度から重度の増悪を軽減する上でのチオトロピウム＋オロダテロール（5/5 µg）固定用量配合剤（FDC）とチオトロピウム5µgの有効性の比較。

基本情報

NCT ID
NCT02296138
ステータス
完了
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
7,903
治験依頼者名
Boehringer Ingelheim

概要

The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

対象疾患

Pulmonary Disease, Chronic Obstructive

介入

olodaterol(DRUG)
tiotropium(DRUG)
tiotropium(DRUG)

依頼者（Sponsor）

日本ベーリンガーインゲルハイム株式会社(INDUSTRY)

実施施設 (50)

1237.19.81125 Boehringer Ingelheim Investigational Site

Okayama, Japan

1237.19.81007 Boehringer Ingelheim Investigational Site

Hokkaido, Chitose, Japan

1237.19.81019 Boehringer Ingelheim Investigational Site

Miyagi, Sendai, Japan

1237.19.81040 Boehringer Ingelheim Investigational Site

Tokyo, Chuo-ku, Japan

1237.19.81030 Boehringer Ingelheim Investigational Site

Chiba, Chiba, Japan

1237.19.81111 Boehringer Ingelheim Investigational Site

Fukuoka, Kurume, Japan

1237.19.81017 Boehringer Ingelheim Investigational Site

Hokkaido, Sapporo, Japan

1237.19.81051 Boehringer Ingelheim Investigational Site

Kanagawa, Yokohama, Japan

1237.19.81011 Boehringer Ingelheim Investigational Site

Hokkaido, Sapporo, Japan

1237.19.81058 Boehringer Ingelheim Investigational Site

Niigata, Niigata, Japan

1237.19.81035 Boehringer Ingelheim Investigational Site

Tokyo, Itabashi-ku, Japan

1237.19.81091 Boehringer Ingelheim Investigational Site

Hyogo, Kobe, Japan

1237.19.81024 Boehringer Ingelheim Investigational Site

Ibaraki, Hitachinaka, Japan

1237.19.81013 Boehringer Ingelheim Investigational Site

Hokkaido, Hakodate, Japan

1237.19.81014 Boehringer Ingelheim Investigational Site

Hokkaido, Sapporo, Japan

1237.19.81009 Boehringer Ingelheim Investigational Site

Hokkaido, Obihiro, Japan

1237.19.81069 Boehringer Ingelheim Investigational Site

Aichi, Seto, Japan

1237.19.81025 Boehringer Ingelheim Investigational Site

Gunma, Fujioka, Japan

1237.19.81048 Boehringer Ingelheim Investigational Site

Tokyo, Toshima-ku, Japan

1237.19.81092 Boehringer Ingelheim Investigational Site

Hyogo, Nishinomiya, Japan

1237.19.81065 Boehringer Ingelheim Investigational Site

Gifu, Ogaki, Japan

1237.19.81119 Boehringer Ingelheim Investigational Site

Okinawa, Urasoe, Japan

1237.19.81038 Boehringer Ingelheim Investigational Site

Miyagi, Sendai, Japan

1237.19.81046 Boehringer Ingelheim Investigational Site

Tokyo, Koto-ku, Japan

1237.19.81093 Boehringer Ingelheim Investigational Site

Hyogo, Himeji, Japan

1237.19.81028 Boehringer Ingelheim Investigational Site

Saitama, Koshigaya, Japan

1237.19.81096 Boehringer Ingelheim Investigational Site

Wakayama, Wakayama, Japan

1237.19.81104 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, Japan

1237.19.81001 Boehringer Ingelheim Investigational Site

Hokkaido, Sapporo, Japan

1237.19.81044 Boehringer Ingelheim Investigational Site

Tokyo, Tachikawa, Japan

1237.19.81042 Boehringer Ingelheim Investigational Site

Tokyo, Shinjuku-ku, Japan

1237.19.81050 Boehringer Ingelheim Investigational Site

Kanagawa, Isehara, Japan

1237.19.81032 Boehringer Ingelheim Investigational Site

Tokyo, Minato-ku, Japan

1237.19.81056 Boehringer Ingelheim Investigational Site

Kanagawa, Sagamihara, Japan

1237.19.81083 Boehringer Ingelheim Investigational Site

Osaka, Sakai, Japan

1237.19.81016 Boehringer Ingelheim Investigational Site

Hokkaido, Otaru, Japan

1237.19.81054 Boehringer Ingelheim Investigational Site

Kanagawa, Sagamihara, Japan

1237.19.81090 Boehringer Ingelheim Investigational Site

Hyogo, Himeji, Japan

1237.19.81010 Boehringer Ingelheim Investigational Site

Hokkaido, Asahikawa, Japan

1237.19.81110 Boehringer Ingelheim Investigational Site

Kochi, Kochi, Japan

1237.19.81126 Boehringer Ingelheim Investigational Site

Tokyo, Japan

1237.19.81101 Boehringer Ingelheim Investigational Site

Hiroshima, Fukuyama, Japan

1237.19.81063 Boehringer Ingelheim Investigational Site

Nagano, Matumoto, Japan

1237.19.81023 Boehringer Ingelheim Investigational Site

Ibaraki, Naka-gun, Japan

1237.19.81120 Boehringer Ingelheim Investigational Site

Okinawa, Uruma, Japan

1237.19.81066 Boehringer Ingelheim Investigational Site

Gifu, Mizunami, Japan

1237.19.81005 Boehringer Ingelheim Investigational Site

Miyagi, Sendai, Japan

1237.19.81081 Boehringer Ingelheim Investigational Site

Osaka, Takatsuki, Japan

1237.19.81106 Boehringer Ingelheim Investigational Site

Yamaguchi, Iwakuni, Japan

1237.19.81064 Boehringer Ingelheim Investigational Site

Nagano, Matsumoto, Japan