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 obstructive airways disease	Drug: albuterol sulfate inhalation aerosol	Phase III

Further Study Details: 

Primary Outcomes: To evaluate safety (adverse events, vital signs, physical exams, ECG monitoring etc.) of cumulative dosing of albuterol sulfate inhalation aerosol
Secondary Outcomes: 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.
Expected Total Enrollment:  80

Ages Eligible for Study:  up to  23 Months,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• 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.

Exclusion criteria:

• 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 ClinicalTrials.gov identifier  NCT00144846

Alabama
      GSK Clinical Trials Call Center, Birmingham,  Alabama,  35216,  United States; Recruiting
Arizona
      GSK Clinical Trials Call Center, Bullhead City,  Arizona,  86442,  United States; Recruiting
California
      GSK Clinical Trials Call Center, Paramount,  California,  90723,  United States; Recruiting
      GSK Clinical Trials Call Center, San Marino,  California,  91108,  United States; Recruiting
      GSK Clinical Trials Call Center, Huntington Beach,  California,  92647,  United States; Recruiting
Colorado
      GSK Clinical Trials Call Center, Denver,  Colorado,  80218,  United States; Recruiting
Florida
      GSK Clinical Trials Call Center, Tampa,  Florida,  33603,  United States; Recruiting
Georgia
      GSK Clinical Trials Call Center, Savannah,  Georgia,  31406,  United States; Recruiting
      GSK Clinical Trials Call Center, Atlanta,  Georgia,  30342,  United States; Recruiting
Illinois
      GSK Clinical Trials Call Center, Dekalb,  Illinois,  60115,  United States; Recruiting
Louisiana
      GSK Clinical Trials Call Center, Metairie,  Louisiana,  70001,  United States; Recruiting
      GSK Clinical Trials Call Center, Mandeville,  Louisiana,  70471,  United States; Recruiting
Missouri
      GSK Clinical Trials Call Center, Kansas City,  Missouri,  64108,  United States; Recruiting
      GSK Clinical Trials Call Center, St. Louis,  Missouri,  63141,  United States; Recruiting
Nebraska
      GSK Clinical Trials Call Center, Alliance,  Nebraska,  69301,  United States; Recruiting
New York
      GSK Clinical Trials Call Center, Utica,  New York,  13502,  United States; Recruiting
      GSK Clinical Trials Call Center, Binghamton,  New York,  13901,  United States; Recruiting
Ohio
      GSK Clinical Trials Call Center, Dayton,  Ohio,  45406,  United States; Recruiting
      GSK Clinical Trials Call Center, Huber Heights,  Ohio,  45424,  United States; Recruiting
Pennsylvania
      GSK Clinical Trials Call Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting
      GSK Clinical Trials Call Center, Pittsburgh,  Pennsylvania,  15214,  United States; Recruiting
Texas
      GSK Clinical Trials Call Center, Tomball,  Texas,  77070,  United States; Recruiting
      GSK Clinical Trials Call Center, Dallas,  Texas,  75230,  United States; Recruiting
Puerto Rico
      GSK Clinical Trials Call Center, Ponce,  00716,  Puerto Rico; Recruiting
      GSK Clinical Trials Call Center, Hato Rey,  00917,  Puerto Rico; Recruiting

Study chairs or principal investigators

GSK Clinical Trials, MD,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  SB030002
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00144846
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06