Inhaled Albuterol Sulfate For Acute Wheezing Due To Obstructive Airways Disease In Children

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).