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This study evaluates the effect of cumulative dose administration of albuterol sulfate inhalation aerosol delivered with valved holding chamber and facemask. This is a four week study in birth to 23 month old subjects who are experiencing acute wheezing due to obstructive airways disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albuterol sulfate inhalation aerosol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety (adverse events, vital signs, physical exams, ECG monitoring etc.) of cumulative dosing of albuterol sulfate inhalation aerosol |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy measures (percent change from baseline over entire treatment period in the TAL score, respiratory rate, wheezing etc.) of cumulative dosing of albuterol sulfate inhalation aerosol. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hoover | Alabama | 35216 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Abstract submitted to AAAAI 2007: Efficacy of Ventolin( HFA MDI cumulative dosing in children <24 months old. AM Davis, MD, W Lincourt, BS, R Trivedi, MS, A Ellsworth, BS, C Crim, MD. GlaxoSmithKline, RTP, NC |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SB030002 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 2, 2017 | |
| Reset | Feb 14, 2018 | |
| Release | Feb 15, 2018 |
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| Fort Mohave |
| Arizona |
| 86426 |
| United States |
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | United States |
| GSK Investigational Site | Alhambra | California | 91801 | United States |
| GSK Investigational Site | Huntington Beach | California | 92647 | United States |
| GSK Investigational Site | Paramount | California | 90723 | United States |
| GSK Investigational Site | Denver | Colorado | 80218 | United States |
| GSK Investigational Site | Clearwater | Florida | 33765 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Savannah | Georgia | 31406 | United States |
| GSK Investigational Site | DeKalb | Illinois | 60115 | United States |
| GSK Investigational Site | Mandeville | Louisiana | 70471 | United States |
| GSK Investigational Site | Metairie | Louisiana | 70001 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02114-3139 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64108 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Alliance | Nebraska | 69301 | United States |
| GSK Investigational Site | Johnson City | New York | 13790 | United States |
| GSK Investigational Site | Utica | New York | 13502 | United States |
| GSK Investigational Site | Columbus | Ohio | 43205 | United States |
| GSK Investigational Site | Dayton | Ohio | 45406 | United States |
| GSK Investigational Site | Huber Heights | Ohio | 45424 | United States |
| GSK Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Houston | Texas | 77070 | United States |
| GSK Investigational Site | Vienna | Virginia | 22180 | United States |
| GSK Investigational Site | Hato Rey | Puerto Rico | 00917 | Puerto Rico |
| GSK Investigational Site | Ponce | Puerto Rico | 00716 | Puerto Rico |
For additional information about this study please refer to the GSK Clinical Study Register |
| SB030002 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SB030002 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SB030002 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SB030002 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SB030002 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SB030002 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 2, 2017 | Feb 14, 2018 | |||
| Feb 15, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D012135 | Respiratory Sounds |
| D001986 | Bronchial Spasm |
| 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 |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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