- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01069289
Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients (SUMIRE)
September 25, 2012 updated by: AstraZeneca
A Phase III, 12-week, Double-blind, Randomised, Parallel-group, Active-controlled, Multinational, Efficacy and Safety Study of Symbicort® Turbuhaler® 160/4.5 μg 2 Inhalations Twice Daily (Bid) Compared to Oxis® Turbuhaler® 4.5 μg 2 Inhalations Twice Daily (Bid) in Patients With Chronic Obstructive Pulmonary Disease
The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1293
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Delhi
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New Delhi, Delhi, India
- Research Site
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Karnataka
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Bangalore, Karnataka, India
- Research Site
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Mysore, Karnataka, India
- Research Site
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Kerala
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Trivandrum, Kerala, India
- Research Site
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Madhya Pradesh
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Indore, Madhya Pradesh, India
- Research Site
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Maharashtra
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Nagpur, Maharashtra, India
- Research Site
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Tamil Nadu
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Coimbatore, Tamil Nadu, India
- Research Site
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Fukuoka, Japan
- Research Site
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Gifu, Japan
- Research Site
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Kochi, Japan
- Research Site
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Kyoto, Japan
- Research Site
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Saga, Japan
- Research Site
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Wakayama, Japan
- Research Site
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Aichi
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Nagoya, Aichi, Japan
- Research Site
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Okazaki, Aichi, Japan
- Research Site
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Seto, Aichi, Japan
- Research Site
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Toyota, Aichi, Japan
- Research Site
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Toyota-shi, Aichi, Japan
- Research Site
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Akita
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Akita-shi, Akita, Japan
- Research Site
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Fukuoka
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Yanagawa, Fukuoka, Japan
- Research Site
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Gifu
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Takayama-shi, Gifu, Japan
- Research Site
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Gunma
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Maebashi, Gunma, Japan
- Research Site
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OTA, Gunma, Japan
- Research Site
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Hiroshima
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Hiroshima-shi, Hiroshima, Japan
- Research Site
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Hokkaido
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Asahikawa, Hokkaido, Japan
- Research Site
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Obihiro, Hokkaido, Japan
- Research Site
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Sapporo, Hokkaido, Japan
- Research Site
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Tomakomai, Hokkaido, Japan
- Research Site
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Hyogo
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Himeji, Hyogo, Japan
- Research Site
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Itami, Hyogo, Japan
- Research Site
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Kobe, Hyogo, Japan
- Research Site
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Ibaragi
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Naka-gun, Ibaragi, Japan
- Research Site
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Ibaraki
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Hitachi, Ibaraki, Japan
- Research Site
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Tsukuba, Ibaraki, Japan
- Research Site
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Ishikawa
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Kanazawa, Ishikawa, Japan
- Research Site
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Kagawa
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Sakaide, Kagawa, Japan
- Research Site
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Kagoshima
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Kagoshima-shi, Kagoshima, Japan
- Research Site
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Kanagawa
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Fujisawa, Kanagawa, Japan
- Research Site
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Kawasaki-shi, Kanagawa, Japan
- Research Site
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Yokohama, Kanagawa, Japan
- Research Site
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Yokohama-shi, Kanagawa, Japan
- Research Site
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Zama-shi, Kanagawa, Japan
- Research Site
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MIE
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Matsusaka-shi, MIE, Japan
- Research Site
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Miyagi
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Sendai, Miyagi, Japan
- Research Site
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Shibata, Miyagi, Japan
- Research Site
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Nagano
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Chino-shi, Nagano, Japan
- Research Site
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Matsumoto, Nagano, Japan
- Research Site
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Nagasaki
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Isahaya-shi, Nagasaki, Japan
- Research Site
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Niigata
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Nagaoka, Niigata, Japan
- Research Site
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Oita
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Saiki-shi, Oita, Japan
- Research Site
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Yufu-shi, Oita, Japan
- Research Site
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Okayama
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Kurashiki-shi, Okayama, Japan
- Research Site
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Okayama-shi, Okayama, Japan
- Research Site
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Okinawa
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Urasoe-shi, Okinawa, Japan
- Research Site
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Osaka
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Izumi-shi, Osaka, Japan
- Research Site
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Kishiwada, Osaka, Japan
- Research Site
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Moriguchi, Osaka, Japan
- Research Site
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Osaka-shi, Osaka, Japan
- Research Site
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Sakai-shi, Osaka, Japan
- Researche Site
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Saitama
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Kitakatsushika-gun, Saitama, Japan
- Research Site
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Koshigaya-shi, Saitama, Japan
- Research Site
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Shimane
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Matsue, Shimane, Japan
- Research Site
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Tokyo
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Chuo, Tokyo, Japan
- Research Site
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Itabashi-ku, Tokyo, Japan
- Research Site
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Meguro, Tokyo, Japan
- Research Site
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Minato-ku, Tokyo, Japan
- Research Site
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Setagaya, Tokyo, Japan
- Research Site
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Shinagawa-ku, Tokyo, Japan
- Research Site
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Suginami-ku, Tokyo, Japan
- Research Site
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Sumida-ku, Tokyo, Japan
- Research Site
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Ansan, Korea, Republic of
- Research Site
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Incheon, Korea, Republic of
- Research Site
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Seoul, Korea, Republic of
- Research Site
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Davao City, Philippines
- Research Site
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Iloilo City, Philippines
- Research Site
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Lipa City, Batangas, Philippines
- Research Site
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Olongapo City, Philippines
- Research Site
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Quezon City, Philippines
- Research Site
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Pampanga
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San Fernando, Pampanga, Philippines
- Researche Site
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Bialystok, Poland
- Research Site
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Bydgoszcz, Poland
- Research Site
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Chodziez, Poland
- Research Site
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Jaroslaw, Poland
- Research Site
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Karpacz, Poland
- Research Site
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Krakow, Poland
- Research Site
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Lodz, Poland
- Research Site
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Loma, Poland
- Research Site
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Lublin, Poland
- Research Site
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Ostrow Wielkopolski, Poland
- Research Site
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Pila, Poland
- Research Site
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Poznan, Poland
- Research Site
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Ruda Slaska, Poland
- Research Site
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Slupca, Poland
- Research Site
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Tczew, Poland
- Research Site
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Torun, Poland
- Research Site
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Turek, Poland
- Research Site
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Wloszczowa, Poland
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Zabrze, Poland
- Research Site
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Zawadzkie, Poland
- Research Site
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Znin, Poland
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Novosibirsk, Russian Federation
- Research Site
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Vladikavkaz, Russian Federation
- Research Site
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Russia
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Barnaul, Russia, Russian Federation
- Research Site
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Ekaterinburg, Russia, Russian Federation
- Research Site
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Kazan, Russia, Russian Federation
- Research Site
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Moscow, Russia, Russian Federation
- Research Site
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St.petersburg, Russia, Russian Federation
- Research Site
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Chiayi, Taiwan
- Research Site
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Kaohsiung, Taiwan
- Research Site
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Keelung, Taiwan
- Research Site
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Taipei, Taiwan
- Research Site
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Dnipropetrovsk, Ukraine
- Research Site
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Donetsk, Ukraine
- Research Site
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Kyiv, Ukraine
- Research Site
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Poltava, Ukraine
- Research Site
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Uzhgorod, Ukraine
- Research Site
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Vinytsa, Ukraine
- Research Site
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Zaporozye, Ukraine
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Hanoi, Vietnam
- Research Site
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Ho Chi Minh, Vietnam
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A current clinical diagnosis of Chronic Obstructive Pulmonary Disease
- 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 asthma
- History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily
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2x160/4.5 microgram, inhalation, twice daily, 12 weeks
Other Names:
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Active Comparator: 2
Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily
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2 X 4.5 microgram, inhalation, twice daily, 12 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pre-dose Forced Expiratory Volume in One Second (FEV1)
Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization
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The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
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Before randomization, 0, 4, 8 and 12 weeks after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)
Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization
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The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
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Before randomization, 0, 4, 8 and 12 weeks after randomization
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Pre-dose Forced Vital Capacity (FVC)
Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization
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The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
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Before randomization, 0, 4, 8 and 12 weeks after randomization
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1 Hour Post-dose Forced Vital Capacity (FVC)
Time Frame: Before randomization, 0, 4, 8 and 12 weeks after randomization
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The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
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Before randomization, 0, 4, 8 and 12 weeks after randomization
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Percentage of Participants With Exacerbations
Time Frame: Daily during 12-week randomization treatment
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A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation.
The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.
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Daily during 12-week randomization treatment
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Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Time Frame: Daily during 12-week randomization treatment
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A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation.
Number of COPD exacerbation during 12-week randomization treatment
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Daily during 12-week randomization treatment
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Morning Peak Expiratory Flow(PEF)
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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The change from Run-in period average to Treatment period average for each treatment group
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Daily during run-in period and daily during 12-week randomization treatment
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Evening Peak Expiratory Flow (PEF)
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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The change from Run-in period average to Treatment period average for each treatment group
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Daily during run-in period and daily during 12-week randomization treatment
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Total Number of Day With Exacerbation
Time Frame: Daily during 12-week randomization treatment
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Total number of days with COPD exacerbation for each treatment group
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Daily during 12-week randomization treatment
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Morning Forced Expiratory Volume in One Second (FEV1)
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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The change from Run-in period average to Treatment period average for each treatment group
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Daily during run-in period and daily during 12-week randomization treatment
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Evening Forced Expiratory Volume in One Second (FEV1)
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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The change from Run-in period average to Treatment period average for each treatment group
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Daily during run-in period and daily during 12-week randomization treatment
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Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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Scored 0 to 1 (0 = no awakening and 1 = awakening).
The change from Run-in period average to Treatment period average for each treatment group
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Daily during run-in period and daily during 12-week randomization treatment
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Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition).
The change from Run-in period average to Treatment period average for each treatment group
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Daily during run-in period and daily during 12-week randomization treatment
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Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition).
The change from Run-in period average to Treatment period average for each treatment group
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Daily during run-in period and daily during 12-week randomization treatment
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Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe.
The change from Run-in period average to Treatment period average for each treatment group.
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Daily during run-in period and daily during 12-week randomization treatment
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Use of Rescue Medication
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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The change from Run-in period average to Treatment period average for each treatment group.
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Daily during run-in period and daily during 12-week randomization treatment
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St George's Respiratory Questionnaire (SGRQ) Total Score
Time Frame: Daily during run-in period and daily during 12-week randomization treatment
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The change from Run-in period average to Treatment period average for each treatment group.
The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
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Daily during run-in period and daily during 12-week randomization treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Lars-Göran Carlsson, MD, AstraZeneca R&D, Lund, Sweden
- Principal Investigator: Yoshinosuke Fukuchi, M.D., PhD, Department of Respiratory Medicine, Juntendo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
February 11, 2010
First Submitted That Met QC Criteria
February 16, 2010
First Posted (Estimate)
February 17, 2010
Study Record Updates
Last Update Posted (Estimate)
October 25, 2012
Last Update Submitted That Met QC Criteria
September 25, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Budesonide
- Formoterol Fumarate
- Budesonide, Formoterol Fumarate Drug Combination
Other Study ID Numbers
- D589DC00007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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