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

Completed · Phase 3

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00144846

Run by

GlaxoSmithKline

People needed

80

Starts

2004-09-01

Expected to finish

2006-02-01

Last updated by the study team

2016-09-23

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• GSK Investigational Site — Hoover, Alabama, United States
• GSK Investigational Site — Fort Mohave, Arizona, United States
• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — Alhambra, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Paramount, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Savannah, Georgia, United States
• GSK Investigational Site — DeKalb, Illinois, United States
• GSK Investigational Site — Mandeville, Louisiana, United States
• GSK Investigational Site — Metairie, Louisiana, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Alliance, Nebraska, United States
• GSK Investigational Site — Johnson City, New York, United States
• GSK Investigational Site — Utica, New York, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — Dayton, Ohio, United States
• GSK Investigational Site — Huber Heights, Ohio, United States
• GSK Investigational Site — Hershey, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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