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| ID | Type | Description | Link |
|---|---|---|---|
| D5254C00111 |
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A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma. Patients will receive either Pulmicort or a non-active treatment for three years. Neither patients or investigators will be aware of the treatment received. After three years of treatment all patients will receive Pulmicort for 2 further years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B) | At week 6 and12, and every 3 months thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-bronchodilator FEV1 % of predicted normal | At week 6 and12, and every 3 months thereafter | |
| HE: Asthma related events and health care utilisation, and symptom free days (SFD) | At week 6 and12, and every 3 months thereafter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Romain Pauwels | Steering Committee Chairman | Study Chair |
| William Busse | Steering Committee Chairman | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18990678 | Derived | O'Byrne PM, Pedersen S, Lamm CJ, Tan WC, Busse WW; START Investigators Group. Severe exacerbations and decline in lung function in asthma. Am J Respir Crit Care Med. 2009 Jan 1;179(1):19-24. doi: 10.1164/rccm.200807-1126OC. Epub 2008 Oct 31. |
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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 |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
|
| Post-bronchodilator FVC % of predicted | At week 6 and12, and every 3 months thereafter |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |