Status:
COMPLETED
Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Asthma
Eligibility:
All Genders
4-11 years
Phase:
PHASE3
Brief Summary
Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma
Detailed Description
This was a Phase III, double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group study of up to 6 weeks in duration. Seven days of QID single-blind, placebo administration (...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subject and subject's p/l guardian must be willing and able to comply with the study procedures and visit schedules
- Subject, male or female, between the ages of 4 to 11 yrs
- Female subjects 8 yrs or older will have a negative serum pregnancy test
- Must have a documented diagnosis of asthma for a minimum of 6 months prior to study start
- Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 mos. prior to study start
- Must be in good health with the exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
- Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease etc
- Subject's p/l guardian must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions and questionnaire completion, and demonstrate how to use the MiniWright PEF meter
- Exclusion Criteria
- Female subject who is pregnant or lactating
- Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial
- Schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM
- Have travel commitments during the study that would interfere with trial measurements or compliance or both
- Have a history of hospitalization for asthma within 60 days prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial
- Have a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations
- Subject using any prescription drug with which albuterol sulfate administration is contraindicated
- Have currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 mos. prior to study start
- Have a history of cancer
- Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication or that may interfere with the successful completion of this protocol
- Have a history of substance abuse or drug abuse within 12 months preceding V1 or a positive urine drug screening at study start
- Have a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis
- Has suffered from a clinically significant upper or lower respiratory tract infection in the 2 wks prior to study start
- Have a history of cigarette smoking or use of any tobacco products
- Subject who is a relative of a staff member
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00073814
Start Date
December 1 2002
End Date
June 1 2003
Last Update
February 22 2012
Active Locations (45)
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1
Adolescent & Pediatric Associates, PC
Montgomery, Alabama, United States, 36116
2
The Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, United States, 72401
3
Integrated Research Group
Corona, California, United States, 92879
4
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, United States, 92647