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

Condition(s) targeted: Acute Wheezing; Airway Disease

Intervention: albuterol sulfate inhalation aerosol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

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

Study design: Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To evaluate safety (adverse events, vital signs, physical exams, ECG monitoring etc.) of cumulative dosing of albuterol sulfate inhalation aerosol

Secondary outcome: 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.

Minimum age: N/A. Maximum age: 23 Months. Gender(s): 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).

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Starting date: July 2004
Last updated: January 18, 2008