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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
Show 25 Study Locations| 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 |
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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 |