Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients
NCT ID: NCT00252785
Last Updated: 2011-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
340 participants
INTERVENTIONAL
2005-10-31
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Budesonide/Formoterol
Budesonide
Theophylline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prescribed daily use of an IGCS for \>=12 weeks prior to Visit 1. The dose of IGCS must be 400 to 800 µg/day of Pulmicort® Turbuhaler® or corresponding dose of IGCS. The prescribed dose of IGCS should be constant for at least 4 weeks prior to Visit 1
* Prescribed daily use of sustained release theophylline for at least 8 weeks prior to Visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 µg/mL) during 8 weeks prior to Visit 1. The prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to Visit 1
Exclusion Criteria
* Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1
* Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1
16 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Symbicort Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Komaki, Aichi-ken, Japan
Research Site
Seto, Aichi-ken, Japan
Research Site
Asahi, Chiba, Japan
Research Site
Noda, Chiba, Japan
Research Site
Touon, Ehime, Japan
Research Site
Miyaodai, Fukuoka, Japan
Research Site
Gifu, Gifu, Japan
Research Site
Isesaki, Gunma, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Ōta, Gunma, Japan
Research Site
Ōwa, Gunma, Japan
Research Site
Hiroshima, Hiroshima, Japan
Research Site
Chitose, Hokkaido, Japan
Research Site
Kitahiroshima, Hokkaido, Japan
Research Site
Obihiro, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Tomakomai, Hokkaido, Japan
Research Site
Morioka, Iwate, Japan
Research Site
Takamatsu, Kagawa-ken, Japan
Research Site
Kagoshima, Kagoshima-ken, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Beppu, Ohita, Japan
Research Site
Ōita, Oita Prefecture, Japan
Research Site
Okayama, Okayama-ken, Japan
Research Site
Tsukubo, Okayama-ken, Japan
Research Site
Kishiwada, Osaka, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Oskasayama, Osaka, Japan
Research Site
Takatsuiki, Osaka, Japan
Research Site
Koshigaya, Saitama, Japan
Research Site
Minamisaitama, Saitama, Japan
Research Site
Arakawa City, Tokyo, Japan
Research Site
Chiyoda City, Tokyo, Japan
Research Site
Kodaira, Tokyo, Japan
Research Site
Nakano-ku, Tokyo, Japan
Research Site
Ōta-ku, Tokyo, Japan
Research Site
Shinagawa-ku, Tokyo, Japan
Research Site
Sumida City, Tokyo, Japan
Research Site
tabashi City, Tokyo, Japan
Research Site
Toyama, Toyama, Japan
Research Site
Ube, Yamaguchi, Japan
Research Site
Tochigi, , Japan
Countries
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Other Identifiers
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D5890C00010
Identifier Type: -
Identifier Source: org_study_id
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