Official Title: “An Efficacy, Safety, and Tolerability Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2003

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 (via HFA MDI) was followed by 28 days of QID, double-blind treatment. A follow-up visit was required only for subjects who had, in the opinion of the investigator, a clinically significant finding at Visit 6 /ET that would put the subject at risk. A final follow up phone evaluation was conducted 7 days after the completion of Visit 6/ET.

Intervention(s) in this Clinical Trial

• Drug: Levalbuterol tartrate MDI
  • levalbuterol MDI 90 mcg QID
• Drug: racemic albuterol MDI
  • racemic albuterol MDI 180 mcg QID
• Drug: Placebo
  • Placebo MDI QID

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • levalbuterol MDI 90 mcg QID
• Active Comparator: 2
  • racemic albuterol MDI 190 mcg QID
• Placebo Comparator: 3
  • Placebo MDI QID

Primary Measures

• was peak percent change in FEV1 from visit predose averaged over the double-blind period
  • Time Frame: Week 0, 2, 4
    Safety Issue?: No

Secondary Measures

• under the FEV1 percent change from visit predose curve averaged over the double-blind period
  • Time Frame: Week 0, 2, 4
    Safety Issue?: No
• peak change and peak percent change in FEV1 from visit predose to each visit
  • Time Frame: Week 0, 2, 4
    Safety Issue?: No
• peak change in FEV1 from visit predose to each visit
  • Time Frame: Week 0, 2, 4
    Safety Issue?: No
• peak percent change in FEV1 from study baseline over the double blind period
  • Time Frame: Week 0, 2, 4
    Safety Issue?: No
• time to peak change
  • Time Frame: Week 0, 2, 4
    Safety Issue?: No
• peak percent of predicted FEV1 at each visit and over the double-blind period
  • Time Frame: Week 0, 2, 4
    Safety Issue?: No
• area under the FEV1 percent change from predose curve at each visit
  • Time Frame: Week 0, 2, 4
    Safety Issue?: No
• area under the FEV1 percent change from study baseline curve at each visit and averaged over the double-blind period
  • Time Frame: Week 0, 2, 4
    Safety Issue?: No
• percent of predicted FEV1 AUC at each visit
  • Time Frame: Week 0, 2, 4
    Safety Issue?: No
• percent change in predose FEV1 from study baseline at each visit
  • Time Frame: Week 0, 2, 4
    Safety Issue?: No
• number and percent of responders
  • Time Frame: Week 0, 2, 4
    Safety Issue?: No
• time to onset of response and duration of response
  • Time Frame: Week 0, 2, 4
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 11 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sepracor, Inc.

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00073814

Study ID Number: 051-354

ClinicalTrials.gov Identifier: NCT00073814

Health Authority: United States: Food and Drug Administration