Clinical trial NCT00144846: Inhaled Albuterol Sulfate For Acute Wheezing Due To Obstructive Airways Disease In Children
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: wheezing
bronchospasm
albuterol sulfate HFA
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 80
Sex: ALL
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 month old subjects who are experiencing acute wheezing due to obstructive airways disease.


Eligibility 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).

Primary outcomes:
measure: To evaluate safety (adverse events, vital signs, physical exams, ECG monitoring etc.) of cumulative dosing of albuterol sulfate inhalation aerosol
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Hoover
country: United States
facility: GSK Investigational Site
state: Alabama
city: Fort Mohave
country: United States
facility: GSK Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Alhambra
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Paramount
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: DeKalb
country: United States
facility: GSK Investigational Site
state: Illinois
city: Mandeville
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Alliance
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Johnson City
country: United States
facility: GSK Investigational Site
state: New York
city: Utica
country: United States
facility: GSK Investigational Site
state: New York
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Huber Heights
country: United States
facility: GSK Investigational Site
state: Ohio
city: Hershey
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Vienna
country: United States
facility: GSK Investigational Site
state: Virginia
city: Hato Rey
country: Puerto Rico
facility: GSK Investigational Site
city: Ponce
country: Puerto Rico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Abstract submitted to AAAAI 2007: Efficacy of Ventolin( HFA MDI cumulative dosing in children &lt;24 months old. AM Davis, MD, W Lincourt, BS, R Trivedi, MS, A Ellsworth, BS, C Crim, MD. GlaxoSmithKline, RTP, NC