Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

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

Summary

The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).

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

Details

• Lead Sponsor: Sunovion
• Treatments: Albuterol

Criteria

Inclusion Criteria

• Willing and able to comply with the study procedures and visit schedules

• Male or female, at least 12 years of age

• Female subjects 12-60 years of age must have a negative serum pregnancy test at study start.

• Women of child bearing potential must be using an acceptable method of birth control

• 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 OTC asthma medication for at least 6 months prior to study start

• 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

• Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease, etc.

• Must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions, 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

• 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

• Have a history of hospitalization for asthma within 45 days prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery

• Have a known sensitivity to levalbuterol or racemic albuterol, or any excipients in any of these formulations

• Subject using any prescription drug with which albuterol sulfate administration is contraindicated

• Subject with currently diagnosed life-threatening asthma

• History of cancer (exception: basal cell carcinoma in remission).

• Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication

• History of substance abuse or drug abuse within 12 months preceding study start

• Subject with greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 months of study start

• Documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis

• Have suffered from a clinically significant upper or lower respiratory tract infection in the 2 weeks prior to study start

• Subject who is a staff member or relative of a staff member