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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The Early Head Start program serves lower socioeconomic inner-city children from birth to 3 years. This population has a higher incidence of asthma due to increased exposures. The primary objective of this study is:
To evaluate the effect of early identification of these high risk, inner-city asthmatic infants, age 1-3 years, and early treatment with pulmicort respules on asthma morbidity (asthma symptoms and use of rescue medications), infant pulmonary functions, and use of health care resources (unscheduled clinic visits, emergency room visits and hospitalizations).
To obtain pilot behavior information using Carey Temperament Scale, Bitsea and expand to Itsea if indicated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide respules | Drug | Budesonide respules 0.5 mg nebulized once a day for 4 months of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV0.5 | 2 months and 6 months into study |
| Measure | Description | Time Frame |
|---|---|---|
| emergency room visits | number of visits from baseline to 2 months and 2 months to 6months of study | |
| behavior scores | measured at baseline, 2 months and 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peggy Radford, MD | Contact | 602-546-0985 | pradfor@phoenixchildrens.com |
| Name | Affiliation | Role |
|---|---|---|
| Peggy Radford, MD | Phoenix Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Recruiting | Phoenix | Arizona | 85016 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 28, 2015 | |
| Reset | May 14, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 28, 2015 | May 14, 2015 |
| 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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| number of asthma exacerbations from baseline to 2 months and 2 months to 6 months |
| 6 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |