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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00144846 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Wheezing Airway Disease |
Drug: albuterol sulfate inhalation aerosol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Parallel-Group, Multi-Center Study of Albuterol Sulfate HFA Inhalation Aerosol Delivered Cumulatively With a Valved Holding Chamber and an Attached Facemask in Subjects Between Birth to 23 Months of Age With Acute Wheezing Due to Obstructive Airways Disease |
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2004 |
Eligibility| Ages Eligible for Study: | up to 23 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| GSK Investigational Site | |
| Hoover, Alabama, United States, 35216 | |
| United States, Arizona | |
| GSK Investigational Site | |
| Fort Mohave, Arizona, United States, 86426 | |
| United States, Arkansas | |
| GSK Investigational Site | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| GSK Investigational Site | |
| Paramount, California, United States, 90723 | |
| GSK Investigational Site | |
| Alhambra, California, United States, 91801 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80218 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30342 | |
| GSK Investigational Site | |
| Savannah, Georgia, United States, 31406 | |
| United States, Illinois | |
| GSK Investigational Site | |
| DeKalb, Illinois, United States, 60115 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| Mandeville, Louisiana, United States, 70471 | |
| GSK Investigational Site | |
| Metairie, Louisiana, United States, 70001 | |
| United States, Missouri | |
| GSK Investigational Site | |
| Kansas City, Missouri, United States, 64108 | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| GSK Investigational Site | |
| Alliance, Nebraska, United States, 69301 | |
| United States, New York | |
| GSK Investigational Site | |
| Utica, New York, United States, 13502 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Huber Heights, Ohio, United States, 45424 | |
| GSK Investigational Site | |
| Dayton, Ohio, United States, 45406 | |
| GSK Investigational Site | |
| Columbus, Ohio, United States, 43205 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Hershey, Pennsylvania, United States, 17033 | |
| GSK Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| United States, Texas | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77070 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75230 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Vienna, Virginia, United States, 22180 | |
| Puerto Rico | |
| GSK Investigational Site | |
| Ponce, Puerto Rico, 00716 | |
| GSK Investigational Site | |
| Hato Rey, Puerto Rico, 00917 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | SB030002 |
| Study First Received: | September 1, 2005 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00144846 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
albuterol sulfate HFA wheezing bronchospasm |
|
Respiratory System Agents Neurotransmitter Agents Respiratory Sounds Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists Albuterol Physiological Effects of Drugs Anti-Asthmatic Agents Reproductive Control Agents Adrenergic Agonists |
Pharmacologic Actions Signs and Symptoms Lung Diseases, Obstructive Tocolytic Agents Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Signs and Symptoms, Respiratory Peripheral Nervous System Agents Bronchodilator Agents |