Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT ID: NCT01069289
Last Updated: 2012-10-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1293 participants
INTERVENTIONAL
2010-01-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily
Budesonide/formoterol (Symbicort Turbuhaler)
2x160/4.5 microgram, inhalation, twice daily, 12 weeks
2
Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily
Formoterol (Oxis Turbuhaler)
2 X 4.5 microgram, inhalation, twice daily, 12 weeks
Interventions
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Budesonide/formoterol (Symbicort Turbuhaler)
2x160/4.5 microgram, inhalation, twice daily, 12 weeks
Formoterol (Oxis Turbuhaler)
2 X 4.5 microgram, inhalation, twice daily, 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years
* A smoking history of at least 10 pack years
Exclusion Criteria
* History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Lars-Göran Carlsson, MD
Role: STUDY_CHAIR
AstraZeneca R&D, Lund, Sweden
Yoshinosuke Fukuchi, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Respiratory medicine, Juntendo University
Locations
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Research Site
Bangalore, Karnataka, India
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Mysore, Karnataka, India
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Trivandrum, Kerala, India
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Indore, Madhya Pradesh, India
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Nagpur, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Coimbatore, Tamil Nadu, India
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Nagoya, Aichi-ken, Japan
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Okazaki, Aichi-ken, Japan
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Seto, Aichi-ken, Japan
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Toyota, Aichi-ken, Japan
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Toyota-shi, Aichi-ken, Japan
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Akita, Akita, Japan
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Fukuoka, Fukuoka, Japan
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Yanagawa, Fukuoka, Japan
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Gifu, Gifu, Japan
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Takayama-shi, Gifu, Japan
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Maebashi, Gunma, Japan
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Ōta, Gunma, Japan
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Hiroshima, Hiroshima, Japan
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Asahikawa, Hokkaido, Japan
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Obihiro, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Tomakomai, Hokkaido, Japan
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Himeji, Hyōgo, Japan
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Itami, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Naka-gun, Ibaragi, Japan
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Hitachi, Ibaraki, Japan
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Tsukuba, Ibaraki, Japan
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Kanazawa, Ishikawa-ken, Japan
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Sakaidechō, Kagawa-ken, Japan
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Kagoshima, Kagoshima-ken, Japan
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Fujisawa, Kanagawa, Japan
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Kawasaki-shi, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Zama-shi, Kanagawa, Japan
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Kochi, Kochi, Japan
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Kyoto, Kyoto, Japan
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Matsusaka-shi, Mie-ken, Japan
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Murata, Miyagi, Japan
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Sendai, Miyagi, Japan
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Chino-shi, Nagano, Japan
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Matsumoto, Nagano, Japan
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Isahaya-shi, Nagasaki, Japan
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Nagaoka, Niigata, Japan
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Saiki-shi, Oita Prefecture, Japan
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Yufu-shi, Oita Prefecture, Japan
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Kurashiki-shi, Okayama-ken, Japan
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Okayama, Okayama-ken, Japan
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Urasoe-shi, Okinawa, Japan
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Izumi-shi, Osaka, Japan
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Kishiwada, Osaka, Japan
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Moriguchi, Osaka, Japan
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Osaka, Osaka, Japan
Researche Site
Sakai-shi, Osaka, Japan
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Saga, Saga-ken, Japan
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Kitakatsushika-gun, Saitama, Japan
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Koshigaya-shi, Saitama, Japan
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Matsue, Shimane, Japan
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Chūō, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Meguro City, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Setagaya City, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Suginami-ku, Tokyo, Japan
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Sumida-ku, Tokyo, Japan
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Wakayama, Wakayama, Japan
Researche Site
San Fernando City, Pampanga, Philippines
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Davao City, Philippines, Philippines
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Iloilo City, , Philippines
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Lipa City, Batangas, , Philippines
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Olongapo City, , Philippines
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Quezon City, , Philippines
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Chodzież, , Poland
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Jarosław, , Poland
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Karpacz, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Loma, , Poland
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Lublin, , Poland
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Ostrów Wielkopolski, , Poland
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Piła, , Poland
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Poznan, , Poland
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Ruda Śląska, , Poland
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Słupca, , Poland
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Tczew, , Poland
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Torun, , Poland
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Turek, , Poland
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Włoszczowa, , Poland
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Zabrze, , Poland
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Zawadzkie, , Poland
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Żnin, , Poland
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Barnaul, Russia, Russia
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Kazan', Russia, Russia
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Moscow, Russia, Russia
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Saint Petersburg, Russia, Russia
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Yekaterinburg, Russia, Russia
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Novosibirsk, , Russia
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Vladikavkaz, , Russia
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Ansan, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Chiayi City, , Taiwan
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Kaohsiung City, , Taiwan
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Keelung, , Taiwan
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Taipei, , Taiwan
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Kyiv, , Ukraine
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Poltava, , Ukraine
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Uzhhorod, , Ukraine
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Vinytsa, , Ukraine
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Zaporozye, , Ukraine
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Ho Chi Minh City, Vietnam, Vietnam
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Hanoi, , Vietnam
Countries
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Other Identifiers
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D589DC00007
Identifier Type: -
Identifier Source: org_study_id