Last updated: 11/04/2018 11:30:26
Inhaled Albuterol Sulfate For Acute Wheezing Due To Obstructive Airways Disease In Children
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants with adverse events (AE) and serious adverse events (SAE)
Timeframe: Up to follow-up (5-7 days) after the last dose of study treatment (approximately 8 days)
Number of participants with overall abnormal continuous Holter ECG
Timeframe: Up to 240 minutes (Assessment 10)
Summary of mean pulse oximetry
Timeframe: Up to 240 minutes (Assessment 10)
Change from Baseline (Screening, Assessment 1) in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Timeframe: Baseline (Screening, Assessment 1) and up to 240 minutes (Assessment 10)
Summary of mean respiratory rate (RR)
Timeframe: Up to 240 minutes (Assessment 10)
Change from Baseline (Screening, Assessment 1) in pulse rate (PR)
Timeframe: Baseline (Screening, Assessment 1) and up to 240 minutes (Assessment 10)
Summary of mean body temperature
Timeframe: Up to 240 minutes (Assessment 10)
Change from Baseline (Screening, Assessment 1) in blood glucose and serum potassium
Timeframe: Baseline (Screening, Assessment 1) and 240 minutes (Assessment 10)
Number of participants with arrhythmia on Holter (measured as ventricular and supraventricular ectopic cardiac rhythm abnormalities) as a sign of adrenergic stimulation
Timeframe: Up to 240 minutes (Assessment 10)
Signs of adrenergic stimulation: change from Baseline (Assessment 2) in heart rate from pre to post study dose administration
Timeframe: Baseline (Assessment 2) and up to 240 minutes (Assessment 10)
Number of participants with AEs possibly related to adrenergic stimulation
Timeframe: Up to follow-up (5-7 days) after the last dose of study treatment (approximately 8 days)
Number of participants with pulse rate increase by 20% when compared to Baseline as a signs of adrenergic stimulation
Timeframe: Up to 240 minutes (Assessment 10)
Number of participants with physical examination abnormalities
Timeframe: Up to 240 minutes (Assessment 10)
Secondary outcomes:
Mean percent change from Baseline (Screening, Assessment 1) over the entire treatment period in the Modified Tal Asthma Symptoms Score
Timeframe: Baseline (Screening, Assessment 1) and up to 240 minutes (Assessment 10)
Change from Baseline (Screening, Assessment 1) in the absolute Modified Tal Asthma Symptoms Score over the entire treatment period
Timeframe: Baseline (Screening, Assessment 1) and up to 240 minutes (Assessment 10)
Number of participants with use of rescue albuterol
Timeframe: Up to 240 minutes (Assessment 10)
Interventions:
Drug: Abuterol sulfate inhalation aerosol ( VENTOLIN HFA 180 µg)
Drug: Placebo
Drug: Abuterol sulfate inhalation aerosol ( VENTOLIN HFA 360 µg)
Enrollment:
87
Observational study model:
Not applicable
Primary completion date:
2006-28-02
Time perspective:
Not applicable
Clinical 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
Medical condition
Asthma
Product
salbutamol
Collaborators
Not applicable
Study date(s)
September 2004 to February 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
Not applicable - 23 months
Accepts healthy volunteers
No
- Must be an outpatient.
- Age at second visit must be birth to <24 months old.
- 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.
Inclusion and exclusion 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).
Trial location(s)
Location
GSK Investigational Site
Huber Heights, Ohio, United States, 45424
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114-3139
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70001
Status
Study Complete
Location
GSK Investigational Site
Vienna, Virginia, United States, 22180
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Columbus, Ohio, United States, 43205
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Savannah, Georgia, United States, 31406
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Fort Mohave, Arizona, United States, 86426
Status
Study Complete
Location
GSK Investigational Site
Hato Rey, Puerto Rico, Puerto Rico, 00917
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64108
Status
Study Complete
Location
GSK Investigational Site
Alhambra, California, United States, 91801
Status
Study Complete
Location
GSK Investigational Site
Ponce, Puerto Rico, Puerto Rico, 00716
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Clearwater, Florida, United States, 33765
Status
Study Complete
Location
GSK Investigational Site
Paramount, California, United States, 90723
Status
Study Complete
Location
GSK Investigational Site
Alliance, Nebraska, United States, 69301
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Denver, Colorado, United States, 80218
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Hershey, Pennsylvania, United States, 17033
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Johnson City, New York, United States, 13790
Status
Terminated/Withdrawn
Location
GSK Investigational Site
DeKalb, Illinois, United States, 60115
Status
Study Complete
Location
GSK Investigational Site
Mandeville, Louisiana, United States, 70471
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-28-02
Actual study completion date
2006-28-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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