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The primary objective of this study is to confirm the efficacy (superiority) of Symbicort® Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg twice daily + Theolong® tablet 200 mg twice daily.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/Formoterol | Drug |
| ||
| Budesonide | Drug | |||
| Theophylline | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Morning peak expiratory flow (mPEF) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries | ||
| Forced expiratory volume in one second (FEV1) | ||
| Safety: |
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Inclusion Criteria:
Exclusion Criteria:
Additional inclusion and exclusion criteria will be evaluated by the Investigator
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Symbicort Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Komaki | Aichi-ken | Japan | |||
| Research Site |
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| Adverse events (nature, incidence and severity) |
| Haematology, clinical chemistry and urinalysis |
| 12-lead ECGs, blood pressure, pulse rate |
| - all variables assessed over the 8 week treatment period |
| 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 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D019819 | Budesonide |
| D013806 | Theophylline |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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