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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: albuterol sulfate inhalation aerosol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00144846

SB030002

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

Under 23 months old

Volunteers

No Healthy Volunteers

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).