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
1 other identifier
interventional
80
2 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 asthma
Started Sep 2004
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedSeptember 23, 2016
September 1, 2016
1.4 years
September 1, 2005
September 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate safety (adverse events, vital signs, physical exams, ECG monitoring etc.) of cumulative dosing of albuterol sulfate inhalation aerosol
Secondary Outcomes (1)
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.
Study Arms (1)
Arm 1
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (29)
GSK Investigational Site
Hoover, Alabama, 35216, United States
GSK Investigational Site
Fort Mohave, Arizona, 86426, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Alhambra, California, 91801, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Paramount, California, 90723, United States
GSK Investigational Site
Denver, Colorado, 80218, United States
GSK Investigational Site
Clearwater, Florida, 33765, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Savannah, Georgia, 31406, United States
GSK Investigational Site
DeKalb, Illinois, 60115, United States
GSK Investigational Site
Mandeville, Louisiana, 70471, United States
GSK Investigational Site
Metairie, Louisiana, 70001, United States
GSK Investigational Site
Boston, Massachusetts, 02114-3139, United States
GSK Investigational Site
Kansas City, Missouri, 64108, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Alliance, Nebraska, 69301, United States
GSK Investigational Site
Johnson City, New York, 13790, United States
GSK Investigational Site
Utica, New York, 13502, United States
GSK Investigational Site
Columbus, Ohio, 43205, United States
GSK Investigational Site
Dayton, Ohio, 45406, United States
GSK Investigational Site
Huber Heights, Ohio, 45424, United States
GSK Investigational Site
Hershey, Pennsylvania, 17033, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Houston, Texas, 77070, United States
GSK Investigational Site
Vienna, Virginia, 22180, United States
GSK Investigational Site
Hato Rey, Puerto Rico, 00917, Puerto Rico
GSK Investigational Site
Ponce, Puerto Rico, 00716, Puerto Rico
Related Publications (1)
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
RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 5, 2005
Study Start
September 1, 2004
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
September 23, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.