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| ID | Type | Description | Link |
|---|---|---|---|
| D5896C00717 |
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The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents and adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator | budesonide |
|
| 3 | Active Comparator | formoterol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide/formoterol | Drug |
|
| |
| budesonide |
| Measure | Description | Time Frame |
|---|---|---|
| 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation | FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments | Throughout the 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 |
|---|---|---|---|
| 27039236 | Derived | Tashkin DP, Moore GE, Trudo F, DePietro M, Chipps BE. Assessment of Consistency of Fixed Airflow Obstruction Status during Budesonide/Formoterol Treatment and Its Effects on Treatment Outcomes in Patients with Asthma. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):705-12. doi: 10.1016/j.jaip.2016.02.014. Epub 2016 Mar 30. | |
| 24524222 |
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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 |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Drug |
|
| formoterol | Drug |
|
| Tashkin DP, Chipps BE, Trudo F, Zangrilli JG. Fixed airflow obstruction in asthma: a descriptive study of patient profiles and effect on treatment responses. J Asthma. 2014 Aug;51(6):603-9. doi: 10.3109/02770903.2014.895012. Epub 2014 Mar 19. |
| 22329608 | Derived | Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |