Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Albuterol

Criteria

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