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Tiotropium in the Treatment of the Patients With Chronic Obstructive Pulmonary Disease (COPD)

26. juni 2014 opdateret af: Boehringer Ingelheim

Drug Use Results Survey of Tiotropium Bromide

To collect post-marketing safety and effectiveness information on the use of Tiotropium Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily clinical settings

Studieoversigt

Status

Afsluttet

Betingelser

Lungesygdom, kronisk obstruktiv

Intervention / Behandling

Medicin: Spiriva (tiotropium bromide) inhalation capsules

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

3588

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Japan
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  - Aizubangemachi, Japan
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  - Aizumisatomachi, Japan
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  - Aizuwakamatsu, Japan
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  - Akashi, Japan
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  - Akita, Japan
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  - Ako, Japan
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  - Amagasaki, Japan
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  - Amakusa, Japan
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  - Amimachi, Japan
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  - Anan, Japan
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  - Anjo, Japan
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  - Arakawamachi, Japan
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  - Arao, Japan
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  - Aritacho, Japan
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  - Asahikawa, Japan
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  - Ashikaga, Japan
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  - Atami, Japan
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  - Atsugi, Japan
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  - Awa, Japan
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  - Ayabe, Japan
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  - Ayagawacho, Japan
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  - Ayase, Japan
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  - Beppu, Japan
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  - Bibai, Japan
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  - Bungoohno, Japan
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  - Chiba, Japan
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  - Chigasaki, Japan
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  - Chikusei, Japan
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  - Chikushino, Japan
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  - Chitose, Japan
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  - Date, Japan
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  - Ebetsu, Japan
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  - Echizen, Japan
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  - Emukaecho, Japan
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  - Engarucho, Japan
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  - Fuchuu, Japan
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  - Fuji, Japan
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  - Fujiidera, Japan
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  - Fujikawaguchiko, Japan
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  - Fujinomiya, Japan
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  - Fukagawa, Japan
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  - Fukaya, Japan
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  - Fukuchiyama, Japan
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  - Fukui, Japan
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  - Fukuoka, Japan
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  - Fukuroi, Japan
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  - Fukushima, Japan
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  - Fukutsu, Japan
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  - Fukuyama, Japan
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  - Funabashi, Japan
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  - Futabamachi, Japan
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  - Geiseimura, Japan
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  - Gifu, Japan
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  - Ginowan, Japan
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  - Gobo, Japan
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  - Gosen, Japan
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  - Gotenba, Japan
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  - Gyouda, Japan
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  - Habikino, Japan
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  - Hachinohe, Japan
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  - Hachirogatamachi, Japan
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  - Hagi, Japan
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  - Hakodate, Japan
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  - Hakusan, Japan
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  - Hamada, Japan
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  - Hamamatsu, Japan
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  - Handa, Japan
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  - Hanyuu, Japan
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  - Hatsukaichi, Japan
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  - Hayashimacho, Japan
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  - Higashihiroshima, Japan
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  - Higashimatsushima, Japan
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  - Higashiomi, Japan
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  - Higashiosaka, Japan
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  - Hikari, Japan
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  - Himeji, Japan
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  - Hirakata, Japan
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  - Hiratsuka, Japan
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  - Hirosaki, Japan
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  - Hiroshima, Japan
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  - Hita, Japan
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  - Hitachi, Japan
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  - Hitoyoshi, Japan
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  - Hofu, Japan
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  - Iamabari, Japan
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  - Ibaraki, Japan
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  - Ibarakimachi, Japan
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  - Ibigawacho, Japan
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  - Ibusuki, Japan
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  - Ichihara, Japan
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  - Ichinomiya, Japan
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  - Ichinoseki, Japan
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  - Iga, Japan
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  - Iida, Japan
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  - Iizuka, Japan
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  - Ikoma, Japan
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  - Imari, Japan
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  - Imizu, Japan
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  - Ina, Japan
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  - Inazawa, Japan
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  - Inuyama, Japan
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  - Isahaya, Japan
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  - Ise, Japan
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  - Isehara, Japan
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  - Ishikari, Japan
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  - Ishinomaki, Japan
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  - Itami, Japan
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  - Itanocho, Japan
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  - Ito, Japan
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  - Iwaki, Japan
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  - Iwakuni, Japan
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  - Iwamizawa, Japan
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  - Iwanaicho, Japan
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  - Iwata, Japan
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  - Iyo, Japan
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  - Izu, Japan
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  - Izumisano, Japan
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  - Izumo, Japan
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  - Izunokuni, Japan
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  - Jimokujicho, Japan
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  - Joso, Japan
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  - Jouetsu, Japan
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  - Joyo, Japan
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  - Kaga, Japan
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  - Kagoshima, Japan
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  - Kaizuka, Japan
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  - Kajikicho, Japan
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  - Kakegawa, Japan
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  - Kami, Japan
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  - Kamiamakusa, Japan
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  - Kamisu, Japan
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  - Kanazawa, Japan
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  - Kandamachi, Japan
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  - Kanonji, Japan
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  - Kasai, Japan
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  - Kasama, Japan
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  - Kasaoka, Japan
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  - Kashihara, Japan
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  - Kashima, Japan
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  - Kashiwazaki, Japan
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  - Kasuga, Japan
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  - Kasuigai, Japan
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  - Kasukabe, Japan
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  - Kasuyamachi, Japan
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  - Kato, Japan
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  - Katsuyama, Japan
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  - Kawachinagano, Japan
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  - Kawagoe, Japan
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  - Kawaguchi, Japan
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  - Kawanishimachi, Japan
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  - Kawasaki, Japan
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  - Kayano, Japan
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  - Kazuno, Japan
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  - Kinkocho, Japan
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  - Kitakami, Japan
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  - Kitakyushu, Japan
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  - Kitami, Japan
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  - Kobe, Japan
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  - Kochi, Japan
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  - Koga, Japan
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  - Komonocho, Japan
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  - Konan, Japan
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  - Koriyama, Japan
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  - Kouriyama, Japan
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  - Koushi, Japan
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  - Koushu, Japan
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  - Kozakaicho, Japan
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  - Kudamatsu, Japan
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  - Kumamoto, Japan
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  - Kunimimachi, Japan
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  - Kunisaki, Japan
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  - Kurashiki, Japan
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  - Kurayoshi, Japan
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  - Kure, Japan
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  - Kurihara, Japan
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  - Kurume, Japan
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  - Kushiro, Japan
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  - Kuwana, Japan
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  - Kyotango, Japan
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  - Kyoto, Japan
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  - Maebashi, Japan
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  - Marugame, Japan
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  - Masuda, Japan
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  - Matsudo, Japan
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  - Matsue, Japan
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  - Matsumoto, Japan
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  - Matsusaka, Japan
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  - Matsuyama, Japan
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  - Mibumachi, Japan
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  - Mihamacho, Japan
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  - Mihara, Japan
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  - Minamisatsuma, Japan
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  - Minamisouma, Japan
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  - Minamiuonuma, Japan
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  - Mino, Japan
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  - Minoh, Japan
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  - Misasacho, Japan
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  - Misato, Japan
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  - Mishima, Japan
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  - Mito, Japan
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  - Miyakicho, Japan
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  - Miyakonojo, Japan
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  - Miyazaki, Japan
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  - Miyoshi, Japan
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  - Mizunami, Japan
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  - Mobara, Japan
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  - Moriguchi, Japan
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  - Morioka, Japan
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  - Muroran, Japan
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  - Nabari, Japan
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  - Nagahama, Japan
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  - Nagano, Japan
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  - Nagaoka, Japan
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  - Nagasaki, Japan
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  - Nagato, Japan
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  - Nago, Japan
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  - Nagoya, Japan
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  - Naha, Japan
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  - Nakama, Japan
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  - Nakashibetsucho, Japan
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  - Nanao, Japan
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  - Nankoku, Japan
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  - Nantan, Japan
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  - Nara, Japan
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  - Naruto, Japan
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  - Nasukarasuyama, Japan
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  - Neyagawa, Japan
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  - Nihonmatsu, Japan
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  - Niigata, Japan
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  - Niihamashi, Japan
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  - Nikko, Japan
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  - Nishiiyo, Japan
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  - Nishinomiya, Japan
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  - Nishio, Japan
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  - Nobeoka, Japan
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  - Noboribetsu, Japan
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  - Noda, Japan
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  - Nomi, Japan
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  - Noshiro, Japan
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  - Notocho, Japan
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  - Numata, Japan
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  - Numazu, Japan
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  - Oaraimachi, Japan
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  - Obama, Japan
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  - Obihiro, Japan
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  - Odate, Japan
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  - Odawara, Japan
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  - Ogawaramachi, Japan
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  - Ogi, Japan
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  - Oita, Japan
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  - Ojiya, Japan
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  - Okayama, Japan
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  - Okinawa, Japan
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  - Omihachiman, Japan
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  - Omuta, Japan
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  - Onomachi, Japan
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  - Osaka, Japan
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  - Osakasayama, Japan
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  - Ota, Japan
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  - Otake, Japan
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  - Otaru, Japan
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  - Otsu, Japan
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  - Otsumachi, Japan
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  - Owariasahi, Japan
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  - Ritto, Japan
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  - Ryugasaki, Japan
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  - Sado, Japan
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  - Saga, Japan
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  - Sagamihara, Japan
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  - Saiki, Japan
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  - Saitama, Japan
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  - Sakacho, Japan
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  - Sakai, Japan
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  - Sakaimachi, Japan
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  - Sakaiminato, Japan
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  - Sakata, Japan
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  - Saku, Japan
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  - Sanjyo, Japan
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  - Sanuki, Japan
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  - Sanyoonoda, Japan
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  - Sapporo, Japan
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  - Sasayama, Japan
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  - Sasebo, Japan
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  - Satsumasendai, Japan
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  - Sayama, Japan
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  - Sendai, Japan
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  - Sennan, Japan
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  - Shibetsu, Japan
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  - Shibukawa, Japan
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  - Shimada, Japan
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  - Shimonoseki, Japan
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  - Shimotsuke, Japan
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  - Shimotsuma, Japan
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  - Shingu, Japan
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  - Shiogama, Japan
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  - Shirahamacho, Japan
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  - Shiroishi, Japan
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  - Shiroishicho, Japan
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  - Shizuoka, Japan
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  - Shoocho, Japan
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  - Shunan, Japan
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  - Soo, Japan
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  - Souka, Japan
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  - Suita, Japan
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  - Sukagawa, Japan
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  - Sukumo, Japan
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  - Sunagawa, Japan
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  - Susono, Japan
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  - Suwa, Japan
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  - Suzuka, Japan
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  - Tagawa, Japan
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  - Tainai, Japan
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  - Takahashi, Japan
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  - Takamatsu, Japan
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  - Takaoka, Japan
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  - Takarazuka, Japan
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  - Takasago, Japan
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  - Takashima, Japan
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  - Takatsuki, Japan
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  - Taku, Japan
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  - Tamana, Japan
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  - Tamano, Japan
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  - Tanabe, Japan
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  - Taragimachi, Japan
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  - Tenri, Japan
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  - Tokaimura, Japan
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  - Tokamachi, Japan
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  - Tokorozawa, Japan
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  - Tokunoshimacho, Japan
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  - Tokushima, Japan
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  - Tokyo Adachi-ku, Japan
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  - Tokyo Akishima, Japan
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  - Tokyo Bunkyo-ku, Japan
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  - Tokyo Chiyoda-ku, Japan
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  - Tokyo Edogawa-ku, Japan
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  - Tokyo Hachioji, Japan
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  - Tokyo Higashimurayama, Japan
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  - Tokyo Higashiyamato, Japan
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  - Tokyo Hino, Japan
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  - Tokyo Itabashi-ku, Japan
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  - Tokyo Katsushika-ku, Japan
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  - Tokyo Kiyose, Japan
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  - Tokyo Komae, Japan
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  - Tokyo Koto-ku, Japan
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  - Tokyo Meguro-ku, Japan
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  - Tokyo Minato-ku, Japan
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  - Tokyo Nakano-ku, Japan
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  - Tokyo Nerima-ku, Japan
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  - Tokyo Nishitokyo, Japan
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  - Tokyo Ome, Japan
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  - Tokyo Ota-ku, Japan
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  - Tokyo Setagaya-ku, Japan
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  - Tokyo Shibuya-ku, Japan
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  - Tokyo Shinagawa-ku, Japan
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  - Tokyo Shinjuku-ku, Japan
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  - Tokyo Suginami-ku, Japan
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  - Tokyo Sumida-ku, Japan
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  - Tokyo Taito-ku, Japan
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  - Tokyo Toshima-ku, Japan
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  - Tomakomai, Japan
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  - Tomigusu, Japan
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  - Tomioka, Japan
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  - Tondabayashi, Japan
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  - Toride, Japan
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  - Tottori, Japan
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  - Toyama, Japan
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  - Toyohashi, Japan
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  - Toyokawa, Japan
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  - Toyooka, Japan
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  - Toyosatocho, Japan
    - Boehringer Ingelheim Investigational Site
  - Toyota, Japan
    - Boehringer Ingelheim Investigational Site
  - Tsu, Japan
    - Boehringer Ingelheim Investigational Site
  - Tsukuba, Japan
    - Boehringer Ingelheim Investigational Site
  - Tsurugicho, Japan
    - Boehringer Ingelheim Investigational Site
  - Tsuruoka, Japan
    - Boehringer Ingelheim Investigational Site
  - Tsushima, Japan
    - Boehringer Ingelheim Investigational Site
  - Tsuyama, Japan
    - Boehringer Ingelheim Investigational Site
  - Ube, Japan
    - Boehringer Ingelheim Investigational Site
  - Uchikocho, Japan
    - Boehringer Ingelheim Investigational Site
  - Uchinadamachi, Japan
    - Boehringer Ingelheim Investigational Site
  - Uekimachi, Japan
    - Boehringer Ingelheim Investigational Site
  - Uji, Japan
    - Boehringer Ingelheim Investigational Site
  - Uki, Japan
    - Boehringer Ingelheim Investigational Site
  - Unzen, Japan
    - Boehringer Ingelheim Investigational Site
  - Urakawacho, Japan
    - Boehringer Ingelheim Investigational Site
  - Urasoe, Japan
    - Boehringer Ingelheim Investigational Site
  - Urayasu, Japan
    - Boehringer Ingelheim Investigational Site
  - Uruma, Japan
    - Boehringer Ingelheim Investigational Site
  - Usa, Japan
    - Boehringer Ingelheim Investigational Site
  - Usuki, Japan
    - Boehringer Ingelheim Investigational Site
  - Utsunomiya, Japan
    - Boehringer Ingelheim Investigational Site
  - Wakayama, Japan
    - Boehringer Ingelheim Investigational Site
  - Yabu, Japan
    - Boehringer Ingelheim Investigational Site
  - Yachimata, Japan
    - Boehringer Ingelheim Investigational Site
  - Yachiyo, Japan
    - Boehringer Ingelheim Investigational Site
  - Yaizu, Japan
    - Boehringer Ingelheim Investigational Site
  - Yakumocho, Japan
    - Boehringer Ingelheim Investigational Site
  - Yakushimacho, Japan
    - Boehringer Ingelheim Investigational Site
  - Yamaga, Japan
    - Boehringer Ingelheim Investigational Site
  - Yamagata, Japan
    - Boehringer Ingelheim Investigational Site
  - Yamato, Japan
    - Boehringer Ingelheim Investigational Site
  - Yamatotakada, Japan
    - Boehringer Ingelheim Investigational Site
  - Yanai, Japan
    - Boehringer Ingelheim Investigational Site
  - Yao, Japan
    - Boehringer Ingelheim Investigational Site
  - Yatomi, Japan
    - Boehringer Ingelheim Investigational Site
  - Yatsushiro, Japan
    - Boehringer Ingelheim Investigational Site
  - Yawata, Japan
    - Boehringer Ingelheim Investigational Site
  - Yokkaichi, Japan
    - Boehringer Ingelheim Investigational Site
  - Yokohama, Japan
    - Boehringer Ingelheim Investigational Site
  - Yokosuka, Japan
    - Boehringer Ingelheim Investigational Site
  - Yokote, Japan
    - Boehringer Ingelheim Investigational Site
  - Yonabarucho, Japan
    - Boehringer Ingelheim Investigational Site
  - Yonezawa, Japan
    - Boehringer Ingelheim Investigational Site
  - Yorocho, Japan
    - Boehringer Ingelheim Investigational Site
  - Yoshinocho, Japan
    - Boehringer Ingelheim Investigational Site
  - Yufu, Japan
    - Boehringer Ingelheim Investigational Site
  - Yurihonjou, Japan
    - Boehringer Ingelheim Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

COPD patients in daily clinical settings.

Beskrivelse

Inclusion Criteria:

- Patients with COPD

Exclusion Criteria:

-There is no exclusion criterion, because this post marketing study (PMS) is observational survey under condition of normal clinical practice

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte	Intervention / Behandling
Patienter med KOL	Medicin: Spiriva (tiotropium bromide) inhalation capsules Survey of patients with COPD using Spiriva (tiotropium bromide) inhalation capsules

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Number of patients with adverse events Tidsramme: Up to 4 weeks after start of treatment	Up to 4 weeks after start of treatment
Number of patients with adverse drug reactions Tidsramme: Up to 4 weeks after start of treatment	Up to 4 weeks after start of treatment
Number of patients with serious adverse events Tidsramme: Up to 4 weeks after start of treatment	Up to 4 weeks after start of treatment

Sekundære resultatmål

Resultatmål	Tidsramme
Physician's overall judgement by medical interview into four grades: 1. Improved 2. No Change 3. Aggravated 4.Unassessable Tidsramme: Up to 4 weeks after start of treatment	Up to 4 weeks after start of treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2005

Primær færdiggørelse (Faktiske)

1. september 2007

Datoer for studieregistrering

Først indsendt

31. januar 2008

Først indsendt, der opfyldte QC-kriterier

26. juni 2014

Først opslået (Skøn)

27. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

205.314

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Spiriva (tiotropium bromide) inhalation capsules

Orion Corporation, Orion Pharma

Afsluttet

Inspiratoriske flowparametre med Placebo Easyhaler og Placebo HandiHaler (TIOPIF)

Sund frivillig | KOL

Estland
Solventum US LLC
Quotient Clinical; 3M

Afsluttet

Sammenligning af farmakokinetikken for Tiotropium leveret fra testinhalatorprodukter med to referenceprodukter

Sund og rask

Det Forenede Kongerige
Medical University of Bialystok

Suspenderet

Sammenlignende effektivitet af en gang daglige LAMA/LABA-kombinationer versus tiotropium på konstant arbejdscykeludholdenhed ved KOL (COMPETE)

KOL (kronisk obstruktiv lungesygdom)

Polen
Teva Branded Pharmaceutical Products R&D, Inc.

Afsluttet

At sammenligne farmakokinetikken af Tiotropium hos personer med kronisk obstruktiv lungesygdom (KOL)

KOL

Tyskland
The Korean Academy of Tuberculosis and Respiratory...
GlaxoSmithKline

Afsluttet

Kliniske resultater af Tiotropium Plus Fluticason Propionat/Salmeterol sammenlignet med Tiotropium for kronisk obstruktiv lungesygdom (KOL) i Korea

Kronisk obstruktiv lungesygdom

Korea, Republikken
Boehringer Ingelheim

Afsluttet

Tidlig interventionseffektivitet ved KOL

Lungesygdom, kronisk obstruktiv

Japan
Teva Branded Pharmaceutical Products R&D, Inc.

Trukket tilbage

En undersøgelse af 3 doser Tiotropium Hydrofluoralkane (HFA) Breath Actuated Inhalator (BAI) hos patienter med kronisk obstruktiv lungesygdom

Kronisk obstruktiv lungesygdom | KOL
Boehringer Ingelheim

Afsluttet

Tiotropium/Salmeterol-inhalationspulver (Spiriva Handihaler og Salmeterol PE-kapsel) ved KOL

Lungesygdom, kronisk obstruktiv

Forenede Stater, Østrig, Belgien, Canada, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Italien, Korea, Republikken, Letland, Litauen, Holland, Slovakiet, Sverige
Mylan Inc.
Theravance Biopharma

Afsluttet

Revefenacin Peak Inspiratory Flow Rate (PIFR) undersøgelse i KOL

Kronisk obstruktiv lungesygdom, KOL | Low Peak Inspiratory Flow Rate (PIFR)

Forenede Stater
Chiesi Farmaceutici S.p.A.

Afsluttet

Effektiviteten af fast kombination af Beclometason + Formoterol + Glycopyrrolat ved kronisk obstruktiv lungesygdom

Kronisk obstruktiv lungesygdom

Italien, Tyskland, Ungarn

Tiotropium in the Treatment of the Patients With Chronic Obstructive Pulmonary Disease (COPD)

Drug Use Results Survey of Tiotropium Bromide

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Faktiske)

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Prøveudtagningsmetode

Studiebefolkning

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Tidsramme

Sekundære resultatmål

Resultatmål

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Spiriva (tiotropium bromide) inhalation capsules

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Austria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer