Status:
COMPLETED
Inhaled Albuterol Sulfate For Acute Wheezing Due To Obstructive Airways Disease In Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
Up to 23 years
Phase:
PHASE3
Brief Summary
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 m...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00144846
Start Date
September 1 2004
End Date
February 1 2006
Last Update
September 23 2016
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Hoover, Alabama, United States, 35216
2
GSK Investigational Site
Fort Mohave, Arizona, United States, 86426
3
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
4
GSK Investigational Site
Alhambra, California, United States, 91801