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

Information source: Sepracor, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI (Drug); Racemic Albuterol followed by levalbuterol HFA MDI (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Sepracor, Inc.

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

Clinical Details

Official title: A Cumulative Dose Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatric Subjects With Asthma

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study

Primary outcome: Increases from visit pre-dose to each post-dose dose measurement in heart rate, blood pressure (systolic and diastolic), potassium and glucose

Secondary outcome:

Percent change in FEV1 (from visit pre-dose to each post dose measure)

Percent change in FVC (from visit pre-dose to each post dose measure)

Percent change in FEF25-75% (from visit pre-dose to each post dose measure)

Number of cumulative actuations received

Detailed description: A randomized, double-blind, active-controlled multicenter, two-way crossover study of HFA levalbuterol (with and without a spacer) in subjects 4-11 years of age with asthma

Eligibility

Minimum age: 4 Years. Maximum age: 11 Years. Gender(s): Both.

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.

Locations and Contacts

Madera, California, United States

San Diego, California, United States

Savannah, Georgia, United States

Louisville, Kentucky, United States

Cortland, New York, United States

Medford, Oregon, United States

Portland, Oregon, United States

Chester, Pennsylvania, United States

Knoxville, Tennessee, United States

Houston, Texas, United States

Dallas, Texas, United States

Additional Information

Starting date: January 2003
Ending date: July 2003
Last updated: June 19, 2008

Page last updated: June 20, 2008

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