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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Airway Disease; Asthma; Acute Wheezing

Intervention: albuterol sulfate inhalation aerosol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

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

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

Secondary outcome: 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.

Eligibility

Minimum age: N/A. Maximum age: 23 Months. Gender(s): Both.

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).

Locations and Contacts

GSK Investigational Site, Hato Rey 00917, Puerto Rico

GSK Investigational Site, Ponce 00716, Puerto Rico

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, Paramount, California 90723, United States

GSK Investigational Site, Denver, Colorado 80218, 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, 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, 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

Additional Information

Starting date: September 2004
Last updated: March 1, 2013

Page last updated: August 23, 2015

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