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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: September 1, 2005
Last updated: March 1, 2013
Last verified: March 2013
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.

Condition Intervention Phase
Airway Disease
Acute Wheezing
Drug: albuterol sulfate inhalation aerosol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 80
Study Start Date: September 2004
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   up to 23 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT00144846

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Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

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

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00144846     History of Changes
Other Study ID Numbers: SB030002 
Study First Received: September 1, 2005
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
albuterol sulfate HFA

Additional relevant MeSH terms:
Respiratory Sounds
Lung Diseases, Obstructive
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 25, 2016