Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma

• Status: Completed
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years of age with asthma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Albuterol

Criteria

Inclusion Criteria:

• Subject, male or female, must be between the ages of 4 to 11 years, inclusive, at the time of consent.

• Female subjects who are 8 years of age or older will have a negative serum pregnancy test at study start.

• 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 or have one taken within 12 months prior to randomization may be used.

• 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 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 Criteria:

• Female subject who is pregnant or lactating.

• Subject who has participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial.

• Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM.

• 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.

• 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 2 weeks prior to study start.

• Subject 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.