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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144846
• Other study ID #: SB030002
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2005
• Last updated: September 22, 2016
• Start date: September 2004
• Est. completion date: February 2006

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 23 Months

Eligibility

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).

Related Conditions & MeSH terms

• Asthma
• Lung Diseases, Obstructive
• Respiratory Sounds

Intervention

Drug:
• albuterol sulfate inhalation aerosol

Locations

Country	Name	City	State
Puerto Rico	GSK Investigational Site	Hato Rey
Puerto Rico	GSK Investigational Site	Ponce
United States	GSK Investigational Site	Alhambra	California
United States	GSK Investigational Site	Alliance	Nebraska
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	DeKalb	Illinois
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Fort Mohave	Arizona
United States	GSK Investigational Site	Hershey	Pennsylvania
United States	GSK Investigational Site	Hoover	Alabama
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huber Heights	Ohio
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Johnson City	New York
United States	GSK Investigational Site	Jonesboro	Arkansas
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Mandeville	Louisiana
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Paramount	California
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Utica	New York
United States	GSK Investigational Site	Vienna	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate safety (adverse events, vital signs, physical exams, ECG monitoring etc.) of cumulative dosing of albuterol sulfate inhalation aerosol
Secondary	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.

External Links

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