Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to confirm the safety of Symbicort® Turbuhaler® 160/4.5 µg 1, 2 or 4 inhalation b.i.d. over a 52 week treatment period in asthmatic patients who are being treated with IGCS and long acting β2-agonist (LABA) and/or other anti-asthmatic drugs.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/Formoterol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Adverse events (nature, incidence and severity) Haematology, clinical chemistry, morning plasma cortisol, urinalysis, and ACTH challenge test 12-lead ECGs, blood pressure, pulse rate |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcomes regarding disease status (incl. PEF), collected via diaries | ||
| Forced expiratory volume in one second (FEV1) | ||
| - all variables assessed over the 52 week treatment period |
Not provided
Inclusion Criteria:
Theophylline, long acting β2-agonist (LABA), other anti-asthmatic drugs (leucotrine antagonists, inhaled anti-cholinergics, Th2 cytokine inhibitor) for at least 4 weeks prior to Visit 1 at a constant dose
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Seto |
| Aichi-ken |
| Japan |
| Research Site | Gifu | Gifu | Japan |
| Research Site | Ōwa | Gunma | Japan |
| Research Site | Hiroshima | Hiroshima | 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 | Kochi | Kochi | Japan |
| Research Site | Beppu | Ohita | Japan |
| Research Site | Tsukubo-gun | Okayama-ken | Japan |
| Research Site | Kishiwada | Osaka | Japan |
| Research Site | Takatsuki | Osaka | Japan |
| Research Site | Ōta-ku | Tokyo | Japan |
| Research Site | Shinjuku-ku | Tokyo | Japan |
| Research Site | Ube | Yamaguchi | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided