Status:
COMPLETED
Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol in Pediatric Subjects
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Asthma
Bronchoconstriction
Eligibility:
All Genders
6-11 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate, using an exercise challenge approach, the dose response of levalbuterol HFA MDI in pediatric subjects with asthma
Detailed Description
A randomized, double-blind, active controlled, multicenter, parallel treatment, 3x3 dose level crossover study evaluating the dose response of levalbuterol in pediatric subjects between the ages of 6 ...
Eligibility Criteria
Inclusion
- Subject, male or female, must be between the ages of 6 to 11 years, inclusive, at the time of consent.
- Female subjects who are 8 years of age or older must have a negative serum pregnancy test.
- Subject must have a documented diagnosis of asthma for a minimum of 6 months prior to study start
- Subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
- Subject must have a chest X-ray for the study or within 12 months prior to randomization.
- Subject's parent/legal guardian must be able to complete the diary cards and medical event calendars reliably on a daily basis and understand dosing instructions. Any minor subject who is not able to do this must have a parent/legal guardian who can assist them during the study with these activities.
Exclusion
- Female subject who is pregnant or lactating.
- Subject who has participated in an investigational drug study within 30 days of study start, or who is currently participating in another clinical trial.
- Subject whose schedule prevents him or her from starting study visits before 2:30-4:00 PM.
- Subject who is unwilling or physically unable to perform the exercise challenges as described in the protocol.
- Subject who has travel commitments during the study that would interfere with trial measurements or compliance or both.
- Subject who has a history of hospitalization for asthma within 4 weeks prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
- Subject with 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.
- Subject with currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior to study start.
- Subject with a history of cancer (exception: basal cell carcinoma in remission).
- Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
- Subject with a history of substance abuse or drug abuse within 12 months preceding study start.
- Subject with a history of cigarette smoking or use of any tobacco products.
- Subject with a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis.
- Subject who has suffered from a clinically significant upper or lower respiratory tract infection in the 3 weeks prior to study start.
- Subjects with unstable asthma; or who have had a change in asthma therapy; or a visit to the Emergency Department or hospital for worsening asthma within 4 weeks.
- Subject who is a staff member or relative of a staff member.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00685347
Start Date
January 1 2003
End Date
June 1 2003
Last Update
February 22 2012
Active Locations (6)
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1
Long Beach, California, United States
2
Denver, Colorado, United States
3
Englewood, Colorado, United States
4
Russells Mills, Massachusetts, United States