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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: albuterol sulfate inhalation aerosol

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Hato Rey, Puerto Rico, 00917
    • GSK Investigational Site
  • Ponce, Puerto Rico, 00716
    • GSK Investigational Site
• United States
  • Alabama
    • Hoover, Alabama, United States, 35216
      • GSK Investigational Site
  • Arizona
    • Fort Mohave, Arizona, United States, 86426
      • GSK Investigational Site
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • GSK Investigational Site
  • California
    • Alhambra, California, United States, 91801
      • GSK Investigational Site
    • Huntington Beach, California, United States, 92647
      • GSK Investigational Site
    • Paramount, California, United States, 90723
      • GSK Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80218
      • GSK Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33765
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • GSK Investigational Site
    • Savannah, Georgia, United States, 31406
      • GSK Investigational Site
  • Illinois
    • DeKalb, Illinois, United States, 60115
      • GSK Investigational Site
  • Louisiana
    • Mandeville, Louisiana, United States, 70471
      • GSK Investigational Site
    • Metairie, Louisiana, United States, 70001
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114-3139
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • GSK Investigational Site
    • St. Louis, Missouri, United States, 63141
      • GSK Investigational Site
  • Nebraska
    • Alliance, Nebraska, United States, 69301
      • GSK Investigational Site
  • New York
    • Johnson City, New York, United States, 13790
      • GSK Investigational Site
    • Utica, New York, United States, 13502
      • GSK Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43205
      • GSK Investigational Site
    • Dayton, Ohio, United States, 45406
      • GSK Investigational Site
    • Huber Heights, Ohio, United States, 45424
      • GSK Investigational Site
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15241
      • GSK Investigational Site
  • Texas
    • Dallas, Texas, United States, 75230
      • GSK Investigational Site
    • Houston, Texas, United States, 77070
      • GSK Investigational Site
  • Virginia
    • Vienna, Virginia, United States, 22180
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1	Drug: albuterol sulfate inhalation aerosol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Abstract submitted to AAAAI 2007: Efficacy of Ventolin( HFA MDI cumulative dosing in children <24 months old. AM Davis, MD, W Lincourt, BS, R Trivedi, MS, A Ellsworth, BS, C Crim, MD. GlaxoSmithKline, RTP, NC

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): February 1, 2006
• Study Completion (Actual): February 1, 2006

Study Registration Dates

• First Submitted: September 1, 2005
• First Submitted That Met QC Criteria: September 1, 2005
• First Posted (Estimate): September 5, 2005

Study Record Updates

• Last Update Posted (Estimate): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: wheezing; bronchospasm; albuterol sulfate HFA
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Respiratory Sounds; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: SB030002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Clinical Study Report
   Information identifier: SB030002
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Annotated Case Report Form
   Information identifier: SB030002
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: SB030002
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Study Protocol
   Information identifier: SB030002
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Dataset Specification
   Information identifier: SB030002
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Statistical Analysis Plan
   Information identifier: SB030002
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Informed Consent Form
   Information identifier: SB030002
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register