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| ID | Type | Description | Link |
|---|---|---|---|
| D5896C00725 |
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The purpose of this study is to compare Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | budesonide/formoterol |
|
| 2 | Active Comparator | budesonide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide/formoterol (Symbicort) | Drug |
|
| |
| budesonide |
| Measure | Description | Time Frame |
|---|---|---|
| Change in evening PEF | Daily throughout the 12 week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes | Daily throughout the 12 week treatment period | |
| Routine safety assessments described in the protocol | 2-4 assessments within 12 week treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Bonuccelli | AstraZeneca | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20713475 | Derived | Eid NS, Noonan MJ, Chipps B, Parasuraman B, Miller CJ, O'Brien CD. Once- vs twice-daily budesonide/formoterol in 6- to 15-year-old patients with stable asthma. Pediatrics. 2010 Sep;126(3):e565-75. doi: 10.1542/peds.2009-2970. Epub 2010 Aug 16. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |