Inhaled Albuterol Sulfate For Acute Wheezing Due To Obstructive Airways Disease In Children
This study has been completed.
Information provided by:
First received: September 1, 2005
Last updated: March 1, 2013
Last verified: March 2013
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.
Drug: albuterol sulfate inhalation aerosol
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- To evaluate safety (adverse events, vital signs, physical exams, ECG monitoring etc.) of cumulative dosing of albuterol sulfate inhalation aerosol
Secondary Outcome Measures:
- 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.
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||February 2006 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||up to 23 Months
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Must be an outpatient.
- Age at second visit must be birth to <24 months old.
- Parent/guardian who is willing to sign, or has signed, an informed consent.
- Must have acute wheezing consistent with reversible obstructive airway disease.
- Must have an asthma symptoms score between 4-9 based on the TAL score (Modified Tal Asthma Symptoms Score measured by the study site) at Screening (Visit 1) while the subject is breathing room air.
- History of life-threatening asthma or wheezing that requires admission to an intensive care unit for treatment within 3 months prior to Screening, or he/she has been treated in the emergency room and admitted to the hospital for airways obstruction on two or more occasions within 3 months prior to Screening, or there is a history of intubation for respiratory distress due to airways obstruction.
- Has impending respiratory failure.
- Taken medications such as acute/chronic systemic corticosteroids, CNS stimulants, investigational medications, theophylline or aminophylline, anti-arrhythmic within a certain time period prior to the study.
- Having the following signs or symptoms: 1)present with fever (rectal temperature >100.5 ºF or tympanic temperature >101.5ºF); 2) present with known pulmonary (lung) and/or cardiac (heart) congenital malformations; 3) have an underlying chronic disease (respiratory (Chronic pulmonary disease includes congenital anomalies, bronchopulmonary dysplasia, and cystic fibrosis), cardiac, renal, or liver insufficiency, immunodeficiency, encephalopathy); 4) known or suspected foreign body aspiration; 5) their Modified Tal Asthma Symptoms Score is 10; 6) their weight is below a certain limit for the average for their age; 8) they were born before 34 weeks' gestation. 9) Laboratory tests for serum potassium and blood glucose within the following limits (potassium between 3.0-5.8 mEq/L and glucose between 45-140mg/dL).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144846
||GSK Clinical Trials, MD
No publications provided
||Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 1, 2005
||March 1, 2013
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
albuterol sulfate HFA
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 05, 2014
Lung Diseases, Obstructive
Respiratory Tract Diseases
Immune System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Reproductive Control Agents
Physiological Effects of Drugs
Adrenergic beta-2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Respiratory System Agents